Dermatology News

A systematic review of nine studies provided limited evidence that off-label oral nonselective beta-blockers can be an effective treatment for facial erythema and flushing in rosacea, while at the same time underscoring the paucity of evidence supporting their use, investigators reported.

“The evidence was highest for carvedilol and propranolol, two nonselective beta-blockers,” wrote the authors of the review, Jade G.M. Logger, MD, of the department of dermatology, Radboud University Medical Center in Nijmegen, the Netherlands, and coauthors. Their review is in the Journal of the American Academy of Dermatology.

The systematic review included a case control study of 53,927 patients and an equal number of controls that evaluated beta-blockers in general, but the remaining studies and case reports included only 106 patients in total. The largest was a prospective cohort study of propranolol in 63 patients. Other studies included a 15-patient randomized clinical trial of nadolol published 31 years ago and three single-patient case reports.

The studies included patients with a history of failed therapies; only a small number of beta-blockers were evaluated. Outcomes reported in the studies varied widely, which ruled out doing a meta-analysis. “Erythema and flushing were assessed by using a wide spectrum of mostly subjective clinical and patient-based scores, and method standardization was often missing,” the researchers stated.

“Most studies showed improved erythema and flushing after initiation of oral beta-blockers,” Dr. Logger and colleagues wrote. Treatment of facial erythema and flushing remains a clinical challenge despite approved therapies, for which poor response and reactivation are common. “Diminishing erythema and flushing in rosacea is challenging because it hardly responds to conventional anti-inflammatory treatment,” they noted.

“The study adds no new evidence to support the use of beta-blockers,” Diane M. Thiboutot, MD, professor of dermatology at Penn State University, Hershey, said in an interview. “As the authors point out, the nine studies reviewed were of low quality with a variety of outcome measures that precluded generation of a meta-analysis, which would have represented new information.”

Dr. Thiboutot is lead author of a 2019 update of management options for rosacea published by the National Rosacea Society Expert Committee last year.. Beta blockers are among the drugs that are sometimes prescribed off label to help rosacea-associated flushing, along with nonsteroidal anti-inflammatory drugs, antihistamines, and clonidine, according to the update.

Dr. Logger and coauthors noted that beta-blockers come with risks, and can aggravate asthma and psoriasis and are contraindicated in patients with heart failure, cardiogenic shock, and other cardiovascular diseases, along with hyperactive airway and Raynaud’s disease. “It is important to monitor patients for adverse effects, especially blood pressure and heart rate,” they stated. Carvedilol and propranolol may have more antioxidant and anti-inflammatory properties than other nonselective beta-blockers that may curtail rosacea manifestations, they wrote.

They called for large, prospective clinical trials to more accurately assess the efficacy of beta-blockers in rosacea patients. “Researchers should further focus on the determination of the optimal dosage, treatment duration, and long-term therapeutic effects for adequate treatment of erythema and flushing in rosacea,” they said.

Getting those trials is challenging, Dr. Thiboutot said. “Objective and even subjective measurement of transient and persistent facial erythema is extremely challenging, particularly in the setting of a prospective clinical trial.” The trials would have to control for a number of variables, including room conditions, patient diet, and timing of medication, and large trials require multiple sites,” which could add to the variability of the data,” she said in the interview. Funding such trials would be difficult because adding an indication for rosacea-related symptoms would have limited commercial potential, she added.

Nonetheless, the studies would be welcome, Dr. Thiboutot said. “If standardized outcome measures for facial erythema were to be developed, a study would be more feasible.”

Dr. Logger disclosed financial relationships with Galderma, AbbVie, Novartis, Janssen, and LEO Pharma; one author disclosed conducting clinical trials for AbbVie and Novartis; the third author disclosed relationships with Galderma, Cutanea Life Sciences, AbbVie, Novartis, and Janssen, with fees paid to his institution. Dr. Thiboutot disclosed a financial relationship with Galderma.
 

SOURCE: Logger JGM et al. J Am Acad Dermatol. 2020 Oct;83(4):1088-97.

A systematic review of nine studies provided limited evidence that off-label oral nonselective beta-blockers can be an effective treatment for facial erythema and flushing in rosacea, while at the same time underscoring the paucity of evidence supporting their use, investigators reported.

“The evidence was highest for carvedilol and propranolol, two nonselective beta-blockers,” wrote the authors of the review, Jade G.M. Logger, MD, of the department of dermatology, Radboud University Medical Center in Nijmegen, the Netherlands, and coauthors. Their review is in the Journal of the American Academy of Dermatology.

The systematic review included a case control study of 53,927 patients and an equal number of controls that evaluated beta-blockers in general, but the remaining studies and case reports included only 106 patients in total. The largest was a prospective cohort study of propranolol in 63 patients. Other studies included a 15-patient randomized clinical trial of nadolol published 31 years ago and three single-patient case reports.

The studies included patients with a history of failed therapies; only a small number of beta-blockers were evaluated. Outcomes reported in the studies varied widely, which ruled out doing a meta-analysis. “Erythema and flushing were assessed by using a wide spectrum of mostly subjective clinical and patient-based scores, and method standardization was often missing,” the researchers stated.

“Most studies showed improved erythema and flushing after initiation of oral beta-blockers,” Dr. Logger and colleagues wrote. Treatment of facial erythema and flushing remains a clinical challenge despite approved therapies, for which poor response and reactivation are common. “Diminishing erythema and flushing in rosacea is challenging because it hardly responds to conventional anti-inflammatory treatment,” they noted.

“The study adds no new evidence to support the use of beta-blockers,” Diane M. Thiboutot, MD, professor of dermatology at Penn State University, Hershey, said in an interview. “As the authors point out, the nine studies reviewed were of low quality with a variety of outcome measures that precluded generation of a meta-analysis, which would have represented new information.”

Dr. Thiboutot is lead author of a 2019 update of management options for rosacea published by the National Rosacea Society Expert Committee last year.. Beta blockers are among the drugs that are sometimes prescribed off label to help rosacea-associated flushing, along with nonsteroidal anti-inflammatory drugs, antihistamines, and clonidine, according to the update.

Dr. Logger and coauthors noted that beta-blockers come with risks, and can aggravate asthma and psoriasis and are contraindicated in patients with heart failure, cardiogenic shock, and other cardiovascular diseases, along with hyperactive airway and Raynaud’s disease. “It is important to monitor patients for adverse effects, especially blood pressure and heart rate,” they stated. Carvedilol and propranolol may have more antioxidant and anti-inflammatory properties than other nonselective beta-blockers that may curtail rosacea manifestations, they wrote.

They called for large, prospective clinical trials to more accurately assess the efficacy of beta-blockers in rosacea patients. “Researchers should further focus on the determination of the optimal dosage, treatment duration, and long-term therapeutic effects for adequate treatment of erythema and flushing in rosacea,” they said.

Getting those trials is challenging, Dr. Thiboutot said. “Objective and even subjective measurement of transient and persistent facial erythema is extremely challenging, particularly in the setting of a prospective clinical trial.” The trials would have to control for a number of variables, including room conditions, patient diet, and timing of medication, and large trials require multiple sites,” which could add to the variability of the data,” she said in the interview. Funding such trials would be difficult because adding an indication for rosacea-related symptoms would have limited commercial potential, she added.

Nonetheless, the studies would be welcome, Dr. Thiboutot said. “If standardized outcome measures for facial erythema were to be developed, a study would be more feasible.”

Dr. Logger disclosed financial relationships with Galderma, AbbVie, Novartis, Janssen, and LEO Pharma; one author disclosed conducting clinical trials for AbbVie and Novartis; the third author disclosed relationships with Galderma, Cutanea Life Sciences, AbbVie, Novartis, and Janssen, with fees paid to his institution. Dr. Thiboutot disclosed a financial relationship with Galderma.
 

SOURCE: Logger JGM et al. J Am Acad Dermatol. 2020 Oct;83(4):1088-97.

A systematic review of nine studies provided limited evidence that off-label oral nonselective beta-blockers can be an effective treatment for facial erythema and flushing in rosacea, while at the same time underscoring the paucity of evidence supporting their use, investigators reported.

“The evidence was highest for carvedilol and propranolol, two nonselective beta-blockers,” wrote the authors of the review, Jade G.M. Logger, MD, of the department of dermatology, Radboud University Medical Center in Nijmegen, the Netherlands, and coauthors. Their review is in the Journal of the American Academy of Dermatology.

The systematic review included a case control study of 53,927 patients and an equal number of controls that evaluated beta-blockers in general, but the remaining studies and case reports included only 106 patients in total. The largest was a prospective cohort study of propranolol in 63 patients. Other studies included a 15-patient randomized clinical trial of nadolol published 31 years ago and three single-patient case reports.

The studies included patients with a history of failed therapies; only a small number of beta-blockers were evaluated. Outcomes reported in the studies varied widely, which ruled out doing a meta-analysis. “Erythema and flushing were assessed by using a wide spectrum of mostly subjective clinical and patient-based scores, and method standardization was often missing,” the researchers stated.

“Most studies showed improved erythema and flushing after initiation of oral beta-blockers,” Dr. Logger and colleagues wrote. Treatment of facial erythema and flushing remains a clinical challenge despite approved therapies, for which poor response and reactivation are common. “Diminishing erythema and flushing in rosacea is challenging because it hardly responds to conventional anti-inflammatory treatment,” they noted.

“The study adds no new evidence to support the use of beta-blockers,” Diane M. Thiboutot, MD, professor of dermatology at Penn State University, Hershey, said in an interview. “As the authors point out, the nine studies reviewed were of low quality with a variety of outcome measures that precluded generation of a meta-analysis, which would have represented new information.”

Dr. Thiboutot is lead author of a 2019 update of management options for rosacea published by the National Rosacea Society Expert Committee last year.. Beta blockers are among the drugs that are sometimes prescribed off label to help rosacea-associated flushing, along with nonsteroidal anti-inflammatory drugs, antihistamines, and clonidine, according to the update.

Dr. Logger and coauthors noted that beta-blockers come with risks, and can aggravate asthma and psoriasis and are contraindicated in patients with heart failure, cardiogenic shock, and other cardiovascular diseases, along with hyperactive airway and Raynaud’s disease. “It is important to monitor patients for adverse effects, especially blood pressure and heart rate,” they stated. Carvedilol and propranolol may have more antioxidant and anti-inflammatory properties than other nonselective beta-blockers that may curtail rosacea manifestations, they wrote.

They called for large, prospective clinical trials to more accurately assess the efficacy of beta-blockers in rosacea patients. “Researchers should further focus on the determination of the optimal dosage, treatment duration, and long-term therapeutic effects for adequate treatment of erythema and flushing in rosacea,” they said.

Getting those trials is challenging, Dr. Thiboutot said. “Objective and even subjective measurement of transient and persistent facial erythema is extremely challenging, particularly in the setting of a prospective clinical trial.” The trials would have to control for a number of variables, including room conditions, patient diet, and timing of medication, and large trials require multiple sites,” which could add to the variability of the data,” she said in the interview. Funding such trials would be difficult because adding an indication for rosacea-related symptoms would have limited commercial potential, she added.

Nonetheless, the studies would be welcome, Dr. Thiboutot said. “If standardized outcome measures for facial erythema were to be developed, a study would be more feasible.”

Dr. Logger disclosed financial relationships with Galderma, AbbVie, Novartis, Janssen, and LEO Pharma; one author disclosed conducting clinical trials for AbbVie and Novartis; the third author disclosed relationships with Galderma, Cutanea Life Sciences, AbbVie, Novartis, and Janssen, with fees paid to his institution. Dr. Thiboutot disclosed a financial relationship with Galderma.
 

SOURCE: Logger JGM et al. J Am Acad Dermatol. 2020 Oct;83(4):1088-97.

Application of oil to the hair and scalp – purported to promote increased shine, health, and growth, and decrease graying of the hair – is used in many different cultures worldwide, including in India and among people of the African diaspora. Hair oiling typically entails combing the hair, followed by applying oil from the roots to the ends about once a week prior to shampooing. Hair oiling daily or every other day, often with a hair braid, is also practiced, using coconut oil or other oils. Oil is found in various hair products and has been popular in the United States, particularly as hot oil treatments in the 1980s.

Oils are used as part of Abhyanga massage, either by an Ayurvedic practitioner or as self-massage, as part of ancient Indian Ayurvedic medicine practice. The type of oil used is determined by the practitioner depending on the individual’s needs; cold-pressed sesame oil or coconut oil is often used as the base oil. Abhyanga is often performed with oil on the entire body as an act of self-care, which includes massage of the hair and scalp. The oil and herbs that are often added to the oil, as well as the scalp massage itself, are explained by practitioners as having therapeutic effects on the hair, including exfoliation of a dry scalp and on overall well-being. Outside of Ayurvedic medicine, hair oiling is also sometimes performed in India as part of routine hair care and can be a bonding experience among parents, grandparents, and children.

Amla oil, which is derived from Indian gooseberry (Phyllanthus emblica L.) and is often used in India on the hair, contains Vitamin C and has been shown to have activity against dermatophytes. In a study conducted in India, amla oil was found to have the most activity against Microsporum canis, M. gypseum, and Trichophyton rubrum, followed by cantharidine and coconut oil, while T. mentagrophytes was most susceptible to coconut oil, followed by amla and cantharidine oil.¹ A study conducted in mice in Thailand found that 5-alpha-reductase was reduced with the dried form of the herb Phyllanthus emblica L, as well as with some other traditional Thai herbs used as hair treatments.²

Castor oil has been utilized in many cultures to promote hair growth. Ricinoleic acid, an unsaturated omega-9 fatty acid and hydroxy acid, is the major component of seed oil obtained from mature castor plants. It has anti-inflammatory and antimicrobial effects, and in one study,³ was found to inhibit prostaglandin D2, which has been implicated in the pathogenesis of androgenetic alopecia.⁴ Jamaican black castor oil is darker in color and has a more alkaline pH compared with traditional castor oil (both contain ricinoleic acid). To produce Jamaican black castor oil, the seed is roasted, ground to a thick paste, boiled in a pot of hot water, then the oil is skimmed off of the top into individual bottles, whereas regular castor oil is cold pressed. The alkalinity of Jamaican black castor oil may play a role in opening up the hair cuticle, which may be beneficial, but application also needs to be followed by a routine that includes closing the cuticle to avoid increasing hair fragility; such a routine could include, for example, leave-in conditioner or rinsing conditioner with colder water.

Castor oil is sometimes used on its own or in combination with other oils, and it is also an ingredient in some hair care products. However, publicly available peer-reviewed research articles demonstrating the effects of castor oil when applied directly to the hair and scalp for hair growth are needed.

Different types of hair oils are used in African American hair care products and, worldwide, by people of the African diaspora as part of regular hair care and hair styling. Common oils include jojoba, coconut, castor, argan, olive, sunflower, and almond oils. Very curly hair often dries out more easily, especially in drier climates; and sebum build-up on the scalp does not occur as quickly, so hair typically does not need to be shampooed frequently. As such, over-shampooing also often dries the hair out faster, especially if hair has been chemically processed. Thus, oils help to coat and protect the hair, and smooth the cuticle. Oils themselves do not moisturize, but can seal moisture into the hair or act as humectants and draw moisture in. Rather than applying on dry hair, oils, when used as daily care as opposed to before shampooing, are often applied on clean hair after shampooing and after a leave-in conditioner has been applied to help seal in moisture for the most benefit. For treatment of scalp conditions, depending on the type of hair care practice performed at home, oils may be preferred over potentially drying solutions and foams if available, for optimum hair care.

Hair oiling is a long-standing practice which, when used correctly, can be beneficial for hair management and health. There are, however, caveats to hair oiling, which include being careful not to excessively brush or comb hair that has a lot of oil in it because the hair is slick, which can cause hair to fall out during combing. Some oils have elevated levels of lauric acid (coconut oil has 50%), which has a high affinity for hair proteins.⁵ While this can support hair strength, care should be taken not to overuse some oils or other products known as “protein packs,” which should be used as directed. Since hair is protein, excess protein build-up coating the hair can block needed moisture, making the hair more knotted and brittle, potentially resulting in more breakage with brushing or other hair care practices.

Some oil-containing hair products also contain artificial fragrances and/or dyes, which in some individuals, may promote an immunogenic effect, such as contact dermatitis. Certain oils, particularly olive oil, can promote an environment favorable to yeast growth, especially Malassezia species, implicated in seborrheic dermatitis. Practices that involve excessive application of oil to the scalp can also result in build up if not shampooed regularly. Sulfonated castor oil (also known as Turkey Red oil) has been reported to cause contact dermatitis.⁶
 

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.

Application of oil to the hair and scalp – purported to promote increased shine, health, and growth, and decrease graying of the hair – is used in many different cultures worldwide, including in India and among people of the African diaspora. Hair oiling typically entails combing the hair, followed by applying oil from the roots to the ends about once a week prior to shampooing. Hair oiling daily or every other day, often with a hair braid, is also practiced, using coconut oil or other oils. Oil is found in various hair products and has been popular in the United States, particularly as hot oil treatments in the 1980s.

Oils are used as part of Abhyanga massage, either by an Ayurvedic practitioner or as self-massage, as part of ancient Indian Ayurvedic medicine practice. The type of oil used is determined by the practitioner depending on the individual’s needs; cold-pressed sesame oil or coconut oil is often used as the base oil. Abhyanga is often performed with oil on the entire body as an act of self-care, which includes massage of the hair and scalp. The oil and herbs that are often added to the oil, as well as the scalp massage itself, are explained by practitioners as having therapeutic effects on the hair, including exfoliation of a dry scalp and on overall well-being. Outside of Ayurvedic medicine, hair oiling is also sometimes performed in India as part of routine hair care and can be a bonding experience among parents, grandparents, and children.

Amla oil, which is derived from Indian gooseberry (Phyllanthus emblica L.) and is often used in India on the hair, contains Vitamin C and has been shown to have activity against dermatophytes. In a study conducted in India, amla oil was found to have the most activity against Microsporum canis, M. gypseum, and Trichophyton rubrum, followed by cantharidine and coconut oil, while T. mentagrophytes was most susceptible to coconut oil, followed by amla and cantharidine oil.¹ A study conducted in mice in Thailand found that 5-alpha-reductase was reduced with the dried form of the herb Phyllanthus emblica L, as well as with some other traditional Thai herbs used as hair treatments.²

Castor oil has been utilized in many cultures to promote hair growth. Ricinoleic acid, an unsaturated omega-9 fatty acid and hydroxy acid, is the major component of seed oil obtained from mature castor plants. It has anti-inflammatory and antimicrobial effects, and in one study,³ was found to inhibit prostaglandin D2, which has been implicated in the pathogenesis of androgenetic alopecia.⁴ Jamaican black castor oil is darker in color and has a more alkaline pH compared with traditional castor oil (both contain ricinoleic acid). To produce Jamaican black castor oil, the seed is roasted, ground to a thick paste, boiled in a pot of hot water, then the oil is skimmed off of the top into individual bottles, whereas regular castor oil is cold pressed. The alkalinity of Jamaican black castor oil may play a role in opening up the hair cuticle, which may be beneficial, but application also needs to be followed by a routine that includes closing the cuticle to avoid increasing hair fragility; such a routine could include, for example, leave-in conditioner or rinsing conditioner with colder water.

Castor oil is sometimes used on its own or in combination with other oils, and it is also an ingredient in some hair care products. However, publicly available peer-reviewed research articles demonstrating the effects of castor oil when applied directly to the hair and scalp for hair growth are needed.

Different types of hair oils are used in African American hair care products and, worldwide, by people of the African diaspora as part of regular hair care and hair styling. Common oils include jojoba, coconut, castor, argan, olive, sunflower, and almond oils. Very curly hair often dries out more easily, especially in drier climates; and sebum build-up on the scalp does not occur as quickly, so hair typically does not need to be shampooed frequently. As such, over-shampooing also often dries the hair out faster, especially if hair has been chemically processed. Thus, oils help to coat and protect the hair, and smooth the cuticle. Oils themselves do not moisturize, but can seal moisture into the hair or act as humectants and draw moisture in. Rather than applying on dry hair, oils, when used as daily care as opposed to before shampooing, are often applied on clean hair after shampooing and after a leave-in conditioner has been applied to help seal in moisture for the most benefit. For treatment of scalp conditions, depending on the type of hair care practice performed at home, oils may be preferred over potentially drying solutions and foams if available, for optimum hair care.

Hair oiling is a long-standing practice which, when used correctly, can be beneficial for hair management and health. There are, however, caveats to hair oiling, which include being careful not to excessively brush or comb hair that has a lot of oil in it because the hair is slick, which can cause hair to fall out during combing. Some oils have elevated levels of lauric acid (coconut oil has 50%), which has a high affinity for hair proteins.⁵ While this can support hair strength, care should be taken not to overuse some oils or other products known as “protein packs,” which should be used as directed. Since hair is protein, excess protein build-up coating the hair can block needed moisture, making the hair more knotted and brittle, potentially resulting in more breakage with brushing or other hair care practices.

Some oil-containing hair products also contain artificial fragrances and/or dyes, which in some individuals, may promote an immunogenic effect, such as contact dermatitis. Certain oils, particularly olive oil, can promote an environment favorable to yeast growth, especially Malassezia species, implicated in seborrheic dermatitis. Practices that involve excessive application of oil to the scalp can also result in build up if not shampooed regularly. Sulfonated castor oil (also known as Turkey Red oil) has been reported to cause contact dermatitis.⁶
 

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.

Application of oil to the hair and scalp – purported to promote increased shine, health, and growth, and decrease graying of the hair – is used in many different cultures worldwide, including in India and among people of the African diaspora. Hair oiling typically entails combing the hair, followed by applying oil from the roots to the ends about once a week prior to shampooing. Hair oiling daily or every other day, often with a hair braid, is also practiced, using coconut oil or other oils. Oil is found in various hair products and has been popular in the United States, particularly as hot oil treatments in the 1980s.

Oils are used as part of Abhyanga massage, either by an Ayurvedic practitioner or as self-massage, as part of ancient Indian Ayurvedic medicine practice. The type of oil used is determined by the practitioner depending on the individual’s needs; cold-pressed sesame oil or coconut oil is often used as the base oil. Abhyanga is often performed with oil on the entire body as an act of self-care, which includes massage of the hair and scalp. The oil and herbs that are often added to the oil, as well as the scalp massage itself, are explained by practitioners as having therapeutic effects on the hair, including exfoliation of a dry scalp and on overall well-being. Outside of Ayurvedic medicine, hair oiling is also sometimes performed in India as part of routine hair care and can be a bonding experience among parents, grandparents, and children.

Amla oil, which is derived from Indian gooseberry (Phyllanthus emblica L.) and is often used in India on the hair, contains Vitamin C and has been shown to have activity against dermatophytes. In a study conducted in India, amla oil was found to have the most activity against Microsporum canis, M. gypseum, and Trichophyton rubrum, followed by cantharidine and coconut oil, while T. mentagrophytes was most susceptible to coconut oil, followed by amla and cantharidine oil.¹ A study conducted in mice in Thailand found that 5-alpha-reductase was reduced with the dried form of the herb Phyllanthus emblica L, as well as with some other traditional Thai herbs used as hair treatments.²

Castor oil has been utilized in many cultures to promote hair growth. Ricinoleic acid, an unsaturated omega-9 fatty acid and hydroxy acid, is the major component of seed oil obtained from mature castor plants. It has anti-inflammatory and antimicrobial effects, and in one study,³ was found to inhibit prostaglandin D2, which has been implicated in the pathogenesis of androgenetic alopecia.⁴ Jamaican black castor oil is darker in color and has a more alkaline pH compared with traditional castor oil (both contain ricinoleic acid). To produce Jamaican black castor oil, the seed is roasted, ground to a thick paste, boiled in a pot of hot water, then the oil is skimmed off of the top into individual bottles, whereas regular castor oil is cold pressed. The alkalinity of Jamaican black castor oil may play a role in opening up the hair cuticle, which may be beneficial, but application also needs to be followed by a routine that includes closing the cuticle to avoid increasing hair fragility; such a routine could include, for example, leave-in conditioner or rinsing conditioner with colder water.

Castor oil is sometimes used on its own or in combination with other oils, and it is also an ingredient in some hair care products. However, publicly available peer-reviewed research articles demonstrating the effects of castor oil when applied directly to the hair and scalp for hair growth are needed.

Different types of hair oils are used in African American hair care products and, worldwide, by people of the African diaspora as part of regular hair care and hair styling. Common oils include jojoba, coconut, castor, argan, olive, sunflower, and almond oils. Very curly hair often dries out more easily, especially in drier climates; and sebum build-up on the scalp does not occur as quickly, so hair typically does not need to be shampooed frequently. As such, over-shampooing also often dries the hair out faster, especially if hair has been chemically processed. Thus, oils help to coat and protect the hair, and smooth the cuticle. Oils themselves do not moisturize, but can seal moisture into the hair or act as humectants and draw moisture in. Rather than applying on dry hair, oils, when used as daily care as opposed to before shampooing, are often applied on clean hair after shampooing and after a leave-in conditioner has been applied to help seal in moisture for the most benefit. For treatment of scalp conditions, depending on the type of hair care practice performed at home, oils may be preferred over potentially drying solutions and foams if available, for optimum hair care.

Hair oiling is a long-standing practice which, when used correctly, can be beneficial for hair management and health. There are, however, caveats to hair oiling, which include being careful not to excessively brush or comb hair that has a lot of oil in it because the hair is slick, which can cause hair to fall out during combing. Some oils have elevated levels of lauric acid (coconut oil has 50%), which has a high affinity for hair proteins.⁵ While this can support hair strength, care should be taken not to overuse some oils or other products known as “protein packs,” which should be used as directed. Since hair is protein, excess protein build-up coating the hair can block needed moisture, making the hair more knotted and brittle, potentially resulting in more breakage with brushing or other hair care practices.

Some oil-containing hair products also contain artificial fragrances and/or dyes, which in some individuals, may promote an immunogenic effect, such as contact dermatitis. Certain oils, particularly olive oil, can promote an environment favorable to yeast growth, especially Malassezia species, implicated in seborrheic dermatitis. Practices that involve excessive application of oil to the scalp can also result in build up if not shampooed regularly. Sulfonated castor oil (also known as Turkey Red oil) has been reported to cause contact dermatitis.⁶
 

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Wesley. Write to them at [email protected]. They had no relevant disclosures.

In this historical portrait, I am focusing mainly on dermatologists who have developed a skin care line, and I am loosely following a chronological order. Thanks to all the readers of Part 1 (The interesting history of dermatologist-developed skin care), who gave me interesting feedback on my Facebook and LinkedIn accounts. There was so much interest that I will write Part 3 next month. Feel free to DM me your ideas on LinkedIn.

The history of dermatologist-developed skin care continues as more dermatologists become interested in developing a skin care line or retailing skin care in their medical practice. A report in July 2020 showed that physician-dispensed skin care is the largest growing segment of the skin care business with a projected compound annual growth rate of 9.9% from 2020 to 2027. I have not seen national sales numbers since this July report, but we have noticed a large increase in online sales for the doctors using my Skin Type Solutions System. This is most likely because, in a national crisis, the self-care and beauty business segments often see growth. So as you can see, dermatologist-dispensed skin care is becoming a major player in national skin care sales. Let’s get back to the story of how this came to be the case.

Peter Elias, MD. Dr. Elias is professor in the department of dermatology at the University of California, San Francisco. In 1996, Dr. Elias published a landmark paper in the Journal of Investigative Dermatology demonstrating that a 1:1:1 ratio of ceramides, fatty acids, and cholesterol is required to repair a damaged skin barrier. He filed multiple patents for using these lipids in moisturizers as early as 1992. His lipid research has stood the test of time, and this paper is still frequently cited. Dr. Elias has authored over 500 peer reviewed articles on the skin barrier, has edited or coauthored three books on skin barrier science, and developed EpiCeram, a product that utilizes ceramide, the fatty acid linoleic acid, and cholesterol. EpiCeram is the only barrier repair moisturizer approved by the Food and Drug Administration and is available by prescription only.

Kathy Fields, MD, and Katie Rodan, MD. Dr. Fields and Dr. Rodan met at Stanford (Calif.) University. In the 1980s, these entrepreneurial dermatologists realized that patients did not understand the role of preventing acne rather than just treating it. As dermatologists, they knew that a consistent daily routine to prevent acne was much more effective than waiting for an outbreak and spot-treating lesions. They took an already available OTC medication – benzoyl peroxide – and educated consumers through infomercials that they needed to stay ahead of acne instead of waiting for a breakout. Using infomercials to sell skin care, selling skin care kits, and educating patients about the need to prevent acne rather than spot treat it was very unusual at the time. As we all know, reeducating your patients is a huge challenge. Dr. Fields and Dr. Rodan changed consumers thinking in a genius way that continues to resonate today by choosing a brand name to make their point: Proactiv. Their simple 3-step acne kit encouraged patients to be proactive about their acne and encouraged compliance. (Patients love exact skin care steps as demonstrated again by the success of the skin care line from plastic surgeon Suzan Obagi, MD, which became available around 1988).

Dr. Fields and Dr. Rodan first offered Proactiv to Neutrogena, which turned it down. This early disappointment did not deter them and ended up benefiting them because this gave them the idea to do infomercials. Guthy Renker agreed to market and distribute the product, and the first Proactiv infomercial appeared on TV in 1995. It quickly became popular and is still one of the best selling skin care lines of all time. It’s important to note that the “overnight success” of Proactiv took at least a decade of effort.

Heather Woolery Lloyd, MD. Dr. Woolery Lloyd got her medical degree at the University of Miami where she also completed her dermatology residency. Her interest in skin of color led to her appointment as director of Ethnic Skin Care at the University of Miami, the country’s first cosmetic ethnic skin care department at a major university. She spent years lecturing around the world on skin of color issues and performing clinical trials before she developed the “Specific Beauty” skin care line for melanin rich skin types. Specific Beauty was acquired by Guthy Renker and is available online. It is the most popular dermatologist developed skin care line for skin of color.

In the late 1980s and early 1990s, other dermatologists threw their hats into the ring and came out with skin care lines – some successful and some not. Unfortunately, many skin care lines at that time were based on “pseudoscience” and exaggerated claims, which fueled the fire of those who felt dermatologists should steer clear of these entrepreneurial pursuits. A debate about the ethics of doctors retailing skin care began, and the controversy led to this 2010 statement by the American Medical Association: “In-office sale of health-related products by physicians presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own.”

Many dermatologists dropped out of the AMA as a result because they felt the organization was no longer representing dermatologist’s interests. After all, we know skin care science better than anyone, and many dermatologists were insulted by the suggestion that we would place our personal financial gain over the best interests of our patients.

This is a perfect example of how the actions of a few unscrupulous dermatologists can affect the entire specialty. I like to focus on the ethical entrepreneurial dermatologists who made great contributions to the skin care industry based on science, efficacy, and patient education and encourage the ethical among us to provide this science-based information to our patients to protect them from pseudoscience-based opportunists. It is obvious that I believe that dermatologists have a responsibility to provide medical advice on skin care to their patients. If not us, who will do it as ethically as we will? But I plead with those of you out there who are promoting foolish stem cell–containing creams and other impossible technologies to remember that you are hurting the credibility of our entire dermatology profession.

In my next column, I will discuss dermatologists who have played a significant role behind the scenes in the development of the skin care industry.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].  

References

Castanedo-Tardan MP, Baumann L. Clin Dermatol. Jul-Aug 2009;27(4):355-8.

Gormley DE. Arch Dermatol. 1999 Jul;135(7):765-6.

Miller RC. Arch Dermatol. 1999 Mar;135(3):255-6.

Virtual Mentor. 2010;12(12):925-7.
 

In this historical portrait, I am focusing mainly on dermatologists who have developed a skin care line, and I am loosely following a chronological order. Thanks to all the readers of Part 1 (The interesting history of dermatologist-developed skin care), who gave me interesting feedback on my Facebook and LinkedIn accounts. There was so much interest that I will write Part 3 next month. Feel free to DM me your ideas on LinkedIn.

The history of dermatologist-developed skin care continues as more dermatologists become interested in developing a skin care line or retailing skin care in their medical practice. A report in July 2020 showed that physician-dispensed skin care is the largest growing segment of the skin care business with a projected compound annual growth rate of 9.9% from 2020 to 2027. I have not seen national sales numbers since this July report, but we have noticed a large increase in online sales for the doctors using my Skin Type Solutions System. This is most likely because, in a national crisis, the self-care and beauty business segments often see growth. So as you can see, dermatologist-dispensed skin care is becoming a major player in national skin care sales. Let’s get back to the story of how this came to be the case.

Peter Elias, MD. Dr. Elias is professor in the department of dermatology at the University of California, San Francisco. In 1996, Dr. Elias published a landmark paper in the Journal of Investigative Dermatology demonstrating that a 1:1:1 ratio of ceramides, fatty acids, and cholesterol is required to repair a damaged skin barrier. He filed multiple patents for using these lipids in moisturizers as early as 1992. His lipid research has stood the test of time, and this paper is still frequently cited. Dr. Elias has authored over 500 peer reviewed articles on the skin barrier, has edited or coauthored three books on skin barrier science, and developed EpiCeram, a product that utilizes ceramide, the fatty acid linoleic acid, and cholesterol. EpiCeram is the only barrier repair moisturizer approved by the Food and Drug Administration and is available by prescription only.

Kathy Fields, MD, and Katie Rodan, MD. Dr. Fields and Dr. Rodan met at Stanford (Calif.) University. In the 1980s, these entrepreneurial dermatologists realized that patients did not understand the role of preventing acne rather than just treating it. As dermatologists, they knew that a consistent daily routine to prevent acne was much more effective than waiting for an outbreak and spot-treating lesions. They took an already available OTC medication – benzoyl peroxide – and educated consumers through infomercials that they needed to stay ahead of acne instead of waiting for a breakout. Using infomercials to sell skin care, selling skin care kits, and educating patients about the need to prevent acne rather than spot treat it was very unusual at the time. As we all know, reeducating your patients is a huge challenge. Dr. Fields and Dr. Rodan changed consumers thinking in a genius way that continues to resonate today by choosing a brand name to make their point: Proactiv. Their simple 3-step acne kit encouraged patients to be proactive about their acne and encouraged compliance. (Patients love exact skin care steps as demonstrated again by the success of the skin care line from plastic surgeon Suzan Obagi, MD, which became available around 1988).

Dr. Fields and Dr. Rodan first offered Proactiv to Neutrogena, which turned it down. This early disappointment did not deter them and ended up benefiting them because this gave them the idea to do infomercials. Guthy Renker agreed to market and distribute the product, and the first Proactiv infomercial appeared on TV in 1995. It quickly became popular and is still one of the best selling skin care lines of all time. It’s important to note that the “overnight success” of Proactiv took at least a decade of effort.

Heather Woolery Lloyd, MD. Dr. Woolery Lloyd got her medical degree at the University of Miami where she also completed her dermatology residency. Her interest in skin of color led to her appointment as director of Ethnic Skin Care at the University of Miami, the country’s first cosmetic ethnic skin care department at a major university. She spent years lecturing around the world on skin of color issues and performing clinical trials before she developed the “Specific Beauty” skin care line for melanin rich skin types. Specific Beauty was acquired by Guthy Renker and is available online. It is the most popular dermatologist developed skin care line for skin of color.

In the late 1980s and early 1990s, other dermatologists threw their hats into the ring and came out with skin care lines – some successful and some not. Unfortunately, many skin care lines at that time were based on “pseudoscience” and exaggerated claims, which fueled the fire of those who felt dermatologists should steer clear of these entrepreneurial pursuits. A debate about the ethics of doctors retailing skin care began, and the controversy led to this 2010 statement by the American Medical Association: “In-office sale of health-related products by physicians presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own.”

Many dermatologists dropped out of the AMA as a result because they felt the organization was no longer representing dermatologist’s interests. After all, we know skin care science better than anyone, and many dermatologists were insulted by the suggestion that we would place our personal financial gain over the best interests of our patients.

This is a perfect example of how the actions of a few unscrupulous dermatologists can affect the entire specialty. I like to focus on the ethical entrepreneurial dermatologists who made great contributions to the skin care industry based on science, efficacy, and patient education and encourage the ethical among us to provide this science-based information to our patients to protect them from pseudoscience-based opportunists. It is obvious that I believe that dermatologists have a responsibility to provide medical advice on skin care to their patients. If not us, who will do it as ethically as we will? But I plead with those of you out there who are promoting foolish stem cell–containing creams and other impossible technologies to remember that you are hurting the credibility of our entire dermatology profession.

In my next column, I will discuss dermatologists who have played a significant role behind the scenes in the development of the skin care industry.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].  

References

Castanedo-Tardan MP, Baumann L. Clin Dermatol. Jul-Aug 2009;27(4):355-8.

Gormley DE. Arch Dermatol. 1999 Jul;135(7):765-6.

Miller RC. Arch Dermatol. 1999 Mar;135(3):255-6.

Virtual Mentor. 2010;12(12):925-7.
 

In this historical portrait, I am focusing mainly on dermatologists who have developed a skin care line, and I am loosely following a chronological order. Thanks to all the readers of Part 1 (The interesting history of dermatologist-developed skin care), who gave me interesting feedback on my Facebook and LinkedIn accounts. There was so much interest that I will write Part 3 next month. Feel free to DM me your ideas on LinkedIn.

The history of dermatologist-developed skin care continues as more dermatologists become interested in developing a skin care line or retailing skin care in their medical practice. A report in July 2020 showed that physician-dispensed skin care is the largest growing segment of the skin care business with a projected compound annual growth rate of 9.9% from 2020 to 2027. I have not seen national sales numbers since this July report, but we have noticed a large increase in online sales for the doctors using my Skin Type Solutions System. This is most likely because, in a national crisis, the self-care and beauty business segments often see growth. So as you can see, dermatologist-dispensed skin care is becoming a major player in national skin care sales. Let’s get back to the story of how this came to be the case.

Peter Elias, MD. Dr. Elias is professor in the department of dermatology at the University of California, San Francisco. In 1996, Dr. Elias published a landmark paper in the Journal of Investigative Dermatology demonstrating that a 1:1:1 ratio of ceramides, fatty acids, and cholesterol is required to repair a damaged skin barrier. He filed multiple patents for using these lipids in moisturizers as early as 1992. His lipid research has stood the test of time, and this paper is still frequently cited. Dr. Elias has authored over 500 peer reviewed articles on the skin barrier, has edited or coauthored three books on skin barrier science, and developed EpiCeram, a product that utilizes ceramide, the fatty acid linoleic acid, and cholesterol. EpiCeram is the only barrier repair moisturizer approved by the Food and Drug Administration and is available by prescription only.

Kathy Fields, MD, and Katie Rodan, MD. Dr. Fields and Dr. Rodan met at Stanford (Calif.) University. In the 1980s, these entrepreneurial dermatologists realized that patients did not understand the role of preventing acne rather than just treating it. As dermatologists, they knew that a consistent daily routine to prevent acne was much more effective than waiting for an outbreak and spot-treating lesions. They took an already available OTC medication – benzoyl peroxide – and educated consumers through infomercials that they needed to stay ahead of acne instead of waiting for a breakout. Using infomercials to sell skin care, selling skin care kits, and educating patients about the need to prevent acne rather than spot treat it was very unusual at the time. As we all know, reeducating your patients is a huge challenge. Dr. Fields and Dr. Rodan changed consumers thinking in a genius way that continues to resonate today by choosing a brand name to make their point: Proactiv. Their simple 3-step acne kit encouraged patients to be proactive about their acne and encouraged compliance. (Patients love exact skin care steps as demonstrated again by the success of the skin care line from plastic surgeon Suzan Obagi, MD, which became available around 1988).

Dr. Fields and Dr. Rodan first offered Proactiv to Neutrogena, which turned it down. This early disappointment did not deter them and ended up benefiting them because this gave them the idea to do infomercials. Guthy Renker agreed to market and distribute the product, and the first Proactiv infomercial appeared on TV in 1995. It quickly became popular and is still one of the best selling skin care lines of all time. It’s important to note that the “overnight success” of Proactiv took at least a decade of effort.

Heather Woolery Lloyd, MD. Dr. Woolery Lloyd got her medical degree at the University of Miami where she also completed her dermatology residency. Her interest in skin of color led to her appointment as director of Ethnic Skin Care at the University of Miami, the country’s first cosmetic ethnic skin care department at a major university. She spent years lecturing around the world on skin of color issues and performing clinical trials before she developed the “Specific Beauty” skin care line for melanin rich skin types. Specific Beauty was acquired by Guthy Renker and is available online. It is the most popular dermatologist developed skin care line for skin of color.

In the late 1980s and early 1990s, other dermatologists threw their hats into the ring and came out with skin care lines – some successful and some not. Unfortunately, many skin care lines at that time were based on “pseudoscience” and exaggerated claims, which fueled the fire of those who felt dermatologists should steer clear of these entrepreneurial pursuits. A debate about the ethics of doctors retailing skin care began, and the controversy led to this 2010 statement by the American Medical Association: “In-office sale of health-related products by physicians presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and undermine the primary obligation of physicians to serve the interests of their patients before their own.”

Many dermatologists dropped out of the AMA as a result because they felt the organization was no longer representing dermatologist’s interests. After all, we know skin care science better than anyone, and many dermatologists were insulted by the suggestion that we would place our personal financial gain over the best interests of our patients.

This is a perfect example of how the actions of a few unscrupulous dermatologists can affect the entire specialty. I like to focus on the ethical entrepreneurial dermatologists who made great contributions to the skin care industry based on science, efficacy, and patient education and encourage the ethical among us to provide this science-based information to our patients to protect them from pseudoscience-based opportunists. It is obvious that I believe that dermatologists have a responsibility to provide medical advice on skin care to their patients. If not us, who will do it as ethically as we will? But I plead with those of you out there who are promoting foolish stem cell–containing creams and other impossible technologies to remember that you are hurting the credibility of our entire dermatology profession.

In my next column, I will discuss dermatologists who have played a significant role behind the scenes in the development of the skin care industry.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann has written two textbooks and a New York Times Best Sellers book for consumers. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Revance, Evolus, and Burt’s Bees. She is the CEO of Skin Type Solutions, a company that independently tests skin care products and makes recommendations to physicians on which skin care technologies are best. Write to her at [email protected].  

References

Castanedo-Tardan MP, Baumann L. Clin Dermatol. Jul-Aug 2009;27(4):355-8.

Gormley DE. Arch Dermatol. 1999 Jul;135(7):765-6.

Miller RC. Arch Dermatol. 1999 Mar;135(3):255-6.

Virtual Mentor. 2010;12(12):925-7.
 

Johnson & Johnson (J&J) on Wednesday said it advanced into phase 3 testing of its COVID-19 vaccine candidate, which uses the same technology as an Ebola vaccine already approved by European regulators.

The National Institute of Allergy and Infectious Diseases, which is aiding Johnson & Johnson with development, described this in a news release as the fourth phase 3 clinical trial of evaluating an investigational vaccine for coronavirus disease.

This NIAID tally tracks products likely to be presented soon for Food and Drug Administration approval. (The World Health Organization’s COVID vaccine tracker lists nine candidates as having reached this stage, including products developed in Russia and China.)

As many as 60,000 volunteers will be enrolled in the trial, with about 215 clinical research sites expected to participate, NIAID said. The vaccine will be tested in the United States and abroad.

The start of this test, known as the ENSEMBLE trial, follows positive results from a Phase 1/2a clinical study, which involved a single vaccination. The results of this study have been submitted to medRxiv and are set to be published online imminently.

New Brunswick, N.J–based J&J said it intends to offer the vaccine on “a not-for-profit basis for emergency pandemic use.” If testing proceeds well, J&J might seek an emergency use clearance for the vaccine, which could possibly allow the first batches to be made available in early 2021.

J&J’s vaccine is unusual in that it will be tested based on a single dose, while other advanced candidates have been tested in two-dose regimens.

J&J on Wednesday also released the study protocol for its phase 3 test. The developers of the other late-stage COVID vaccine candidates also have done this, as reported by Medscape Medical News. Because of the great interest in the COVID vaccine, the American Medical Association had last month asked the FDA to keep physicians informed of their COVID-19 vaccine review process.
 

Trials and tribulations

One of these experimental COVID vaccines already has had a setback in phase 3 testing, which is a fairly routine occurrence in drug development. But with a pandemic still causing deaths and disrupting lives around the world, there has been intense interest in each step of the effort to develop a COVID vaccine.

AstraZeneca PLC earlier this month announced a temporary cessation of all their coronavirus vaccine trials to investigate an “unexplained illness” that arose in a participant, as reported by Medscape Medical News.

On September 12, AstraZeneca announced that clinical trials for the AZD1222, which it developed with Oxford University, had resumed in the United Kingdom. On Wednesday, CNBC said Health and Human Services Secretary Alex Azar told the news station that AstraZeneca’s late-stage coronavirus vaccine trial in the United States remains on hold until safety concerns are resolved, a critical issue with all the fast-track COVID vaccines now being tested.

“Look at the AstraZeneca program, phase 3 clinical trial, a lot of hope. [A] single serious adverse event report in the United Kingdom, global shutdown, and [a] hold of the clinical trials,” Mr. Azar told CNBC.

The New York Times has reported on concerns stemming from serious neurologic illnesses in two participants, both women, who received AstraZeneca’s experimental vaccine in Britain.

The Senate Health, Education, Labor and Pensions Committee on Wednesday separately held a hearing with the leaders of the FDA and the Centers of Disease Control and Prevention, allowing an airing of lawmakers’ concerns about a potential rush to approve a COVID vaccine.
 

Details of J&J trial

The J&J trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also is designed to examine whether the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection, NIAID said.

Principal investigators for the phase 3 trial of the J & J vaccine are Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, MD, PhD, director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh, president and chief executive officer of the South African Medical Research Council and coprincipal investigator of the HIV Vaccine Trials Network.

This article first appeared on Medscape.com.

Johnson & Johnson (J&J) on Wednesday said it advanced into phase 3 testing of its COVID-19 vaccine candidate, which uses the same technology as an Ebola vaccine already approved by European regulators.

The National Institute of Allergy and Infectious Diseases, which is aiding Johnson & Johnson with development, described this in a news release as the fourth phase 3 clinical trial of evaluating an investigational vaccine for coronavirus disease.

This NIAID tally tracks products likely to be presented soon for Food and Drug Administration approval. (The World Health Organization’s COVID vaccine tracker lists nine candidates as having reached this stage, including products developed in Russia and China.)

As many as 60,000 volunteers will be enrolled in the trial, with about 215 clinical research sites expected to participate, NIAID said. The vaccine will be tested in the United States and abroad.

The start of this test, known as the ENSEMBLE trial, follows positive results from a Phase 1/2a clinical study, which involved a single vaccination. The results of this study have been submitted to medRxiv and are set to be published online imminently.

New Brunswick, N.J–based J&J said it intends to offer the vaccine on “a not-for-profit basis for emergency pandemic use.” If testing proceeds well, J&J might seek an emergency use clearance for the vaccine, which could possibly allow the first batches to be made available in early 2021.

J&J’s vaccine is unusual in that it will be tested based on a single dose, while other advanced candidates have been tested in two-dose regimens.

J&J on Wednesday also released the study protocol for its phase 3 test. The developers of the other late-stage COVID vaccine candidates also have done this, as reported by Medscape Medical News. Because of the great interest in the COVID vaccine, the American Medical Association had last month asked the FDA to keep physicians informed of their COVID-19 vaccine review process.
 

Trials and tribulations

One of these experimental COVID vaccines already has had a setback in phase 3 testing, which is a fairly routine occurrence in drug development. But with a pandemic still causing deaths and disrupting lives around the world, there has been intense interest in each step of the effort to develop a COVID vaccine.

AstraZeneca PLC earlier this month announced a temporary cessation of all their coronavirus vaccine trials to investigate an “unexplained illness” that arose in a participant, as reported by Medscape Medical News.

On September 12, AstraZeneca announced that clinical trials for the AZD1222, which it developed with Oxford University, had resumed in the United Kingdom. On Wednesday, CNBC said Health and Human Services Secretary Alex Azar told the news station that AstraZeneca’s late-stage coronavirus vaccine trial in the United States remains on hold until safety concerns are resolved, a critical issue with all the fast-track COVID vaccines now being tested.

“Look at the AstraZeneca program, phase 3 clinical trial, a lot of hope. [A] single serious adverse event report in the United Kingdom, global shutdown, and [a] hold of the clinical trials,” Mr. Azar told CNBC.

The New York Times has reported on concerns stemming from serious neurologic illnesses in two participants, both women, who received AstraZeneca’s experimental vaccine in Britain.

The Senate Health, Education, Labor and Pensions Committee on Wednesday separately held a hearing with the leaders of the FDA and the Centers of Disease Control and Prevention, allowing an airing of lawmakers’ concerns about a potential rush to approve a COVID vaccine.
 

Details of J&J trial

The J&J trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also is designed to examine whether the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection, NIAID said.

Principal investigators for the phase 3 trial of the J & J vaccine are Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, MD, PhD, director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh, president and chief executive officer of the South African Medical Research Council and coprincipal investigator of the HIV Vaccine Trials Network.

This article first appeared on Medscape.com.

Johnson & Johnson (J&J) on Wednesday said it advanced into phase 3 testing of its COVID-19 vaccine candidate, which uses the same technology as an Ebola vaccine already approved by European regulators.

The National Institute of Allergy and Infectious Diseases, which is aiding Johnson & Johnson with development, described this in a news release as the fourth phase 3 clinical trial of evaluating an investigational vaccine for coronavirus disease.

This NIAID tally tracks products likely to be presented soon for Food and Drug Administration approval. (The World Health Organization’s COVID vaccine tracker lists nine candidates as having reached this stage, including products developed in Russia and China.)

As many as 60,000 volunteers will be enrolled in the trial, with about 215 clinical research sites expected to participate, NIAID said. The vaccine will be tested in the United States and abroad.

The start of this test, known as the ENSEMBLE trial, follows positive results from a Phase 1/2a clinical study, which involved a single vaccination. The results of this study have been submitted to medRxiv and are set to be published online imminently.

New Brunswick, N.J–based J&J said it intends to offer the vaccine on “a not-for-profit basis for emergency pandemic use.” If testing proceeds well, J&J might seek an emergency use clearance for the vaccine, which could possibly allow the first batches to be made available in early 2021.

J&J’s vaccine is unusual in that it will be tested based on a single dose, while other advanced candidates have been tested in two-dose regimens.

J&J on Wednesday also released the study protocol for its phase 3 test. The developers of the other late-stage COVID vaccine candidates also have done this, as reported by Medscape Medical News. Because of the great interest in the COVID vaccine, the American Medical Association had last month asked the FDA to keep physicians informed of their COVID-19 vaccine review process.
 

Trials and tribulations

One of these experimental COVID vaccines already has had a setback in phase 3 testing, which is a fairly routine occurrence in drug development. But with a pandemic still causing deaths and disrupting lives around the world, there has been intense interest in each step of the effort to develop a COVID vaccine.

AstraZeneca PLC earlier this month announced a temporary cessation of all their coronavirus vaccine trials to investigate an “unexplained illness” that arose in a participant, as reported by Medscape Medical News.

On September 12, AstraZeneca announced that clinical trials for the AZD1222, which it developed with Oxford University, had resumed in the United Kingdom. On Wednesday, CNBC said Health and Human Services Secretary Alex Azar told the news station that AstraZeneca’s late-stage coronavirus vaccine trial in the United States remains on hold until safety concerns are resolved, a critical issue with all the fast-track COVID vaccines now being tested.

“Look at the AstraZeneca program, phase 3 clinical trial, a lot of hope. [A] single serious adverse event report in the United Kingdom, global shutdown, and [a] hold of the clinical trials,” Mr. Azar told CNBC.

The New York Times has reported on concerns stemming from serious neurologic illnesses in two participants, both women, who received AstraZeneca’s experimental vaccine in Britain.

The Senate Health, Education, Labor and Pensions Committee on Wednesday separately held a hearing with the leaders of the FDA and the Centers of Disease Control and Prevention, allowing an airing of lawmakers’ concerns about a potential rush to approve a COVID vaccine.
 

Details of J&J trial

The J&J trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also is designed to examine whether the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection, NIAID said.

Principal investigators for the phase 3 trial of the J & J vaccine are Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, MD, PhD, director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh, president and chief executive officer of the South African Medical Research Council and coprincipal investigator of the HIV Vaccine Trials Network.

This article first appeared on Medscape.com.

States have begun preparing to distribute a COVID-19 vaccine if one is approved, a CDC official said today.

The CDC released guidance for states on Sept. 16 titled COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. The document discusses vaccine ordering, storage, and handling and says that states should submit their plans for vaccine distribution to the agency by Oct. 16.

“Every jurisdiction is heavily involved right now in their plan development,” CDC official Janell Routh, MD, told the Advisory Committee on Immunization Practices during its Sept. 22 meeting. “It was really impressive to me that, even though the playbook only went out last week, states and jurisdictions have been thinking about this for quite some time.”

However, one committee member suggested that setting a deadline before more safety, efficacy, and storage information is known may be premature.

“I cannot imagine that we will actually know the final storage requirements for this vaccine by Oct. 16, which makes me a little concerned about finalizing state plans,” said Helen “Keipp” Talbot, MD, MPH, associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn. “We also don’t know the best populations yet when it comes to efficacy and safety.”

Dr. Routh said the CDC is asking states to plan on the basis of assumptions. “We know those plans will constantly be improving, changing, as we learn more information,” Dr. Routh said. States agreed to return a plan 30 days after the playbook was released, which is how the Oct. 16 deadline was established, she said.

States are encouraged to think broadly. Plans may include contingencies for a product that requires ultracold storage or for distributing more than one vaccine product, Dr. Routh said.

“One goal is to be ready on the first day that we can actually distribute vaccine,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the meeting. “Our colleagues in Operation Warp Speed say that they expect there will be vaccine as early as November, and therefore we need to be ready so there is no delay in distributing that vaccine. And that phase, that early phase, is really close upon us.”

Many states have already developed plans, and the CDC is providing technical assistance as needed to monitor the plans regularly, Dr. Routh said.
 

Key issues identified

From holding pilot meetings with five jurisdictions, officials learned that public confidence in the vaccine is among states’ greatest concerns, Dr. Routh said. In addition, distribution is resource intensive, and social distancing adds logistical complexity.

Specific guidance on whom to vaccinate in the early stages will smooth the process, officials suggested during the pilot meetings. For the first several weeks, vaccine doses may be limited to priority populations, such as health care workers.

“This interim playbook is a living document,” Dr. Routh emphasized. “We definitely plan to update the content regularly as we learn more information about what vaccines and when they will be released.”

During the early stages of COVID-19 vaccination, officials plan to implement an enhanced monitoring program in which vaccine recipients would complete surveys about adverse events, in addition to the traditional vaccine safety monitoring programs that already exist, officials said.
 

A version of this article originally appeared on Medscape.com.

States have begun preparing to distribute a COVID-19 vaccine if one is approved, a CDC official said today.

The CDC released guidance for states on Sept. 16 titled COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. The document discusses vaccine ordering, storage, and handling and says that states should submit their plans for vaccine distribution to the agency by Oct. 16.

“Every jurisdiction is heavily involved right now in their plan development,” CDC official Janell Routh, MD, told the Advisory Committee on Immunization Practices during its Sept. 22 meeting. “It was really impressive to me that, even though the playbook only went out last week, states and jurisdictions have been thinking about this for quite some time.”

However, one committee member suggested that setting a deadline before more safety, efficacy, and storage information is known may be premature.

“I cannot imagine that we will actually know the final storage requirements for this vaccine by Oct. 16, which makes me a little concerned about finalizing state plans,” said Helen “Keipp” Talbot, MD, MPH, associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn. “We also don’t know the best populations yet when it comes to efficacy and safety.”

Dr. Routh said the CDC is asking states to plan on the basis of assumptions. “We know those plans will constantly be improving, changing, as we learn more information,” Dr. Routh said. States agreed to return a plan 30 days after the playbook was released, which is how the Oct. 16 deadline was established, she said.

States are encouraged to think broadly. Plans may include contingencies for a product that requires ultracold storage or for distributing more than one vaccine product, Dr. Routh said.

“One goal is to be ready on the first day that we can actually distribute vaccine,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the meeting. “Our colleagues in Operation Warp Speed say that they expect there will be vaccine as early as November, and therefore we need to be ready so there is no delay in distributing that vaccine. And that phase, that early phase, is really close upon us.”

Many states have already developed plans, and the CDC is providing technical assistance as needed to monitor the plans regularly, Dr. Routh said.
 

Key issues identified

From holding pilot meetings with five jurisdictions, officials learned that public confidence in the vaccine is among states’ greatest concerns, Dr. Routh said. In addition, distribution is resource intensive, and social distancing adds logistical complexity.

Specific guidance on whom to vaccinate in the early stages will smooth the process, officials suggested during the pilot meetings. For the first several weeks, vaccine doses may be limited to priority populations, such as health care workers.

“This interim playbook is a living document,” Dr. Routh emphasized. “We definitely plan to update the content regularly as we learn more information about what vaccines and when they will be released.”

During the early stages of COVID-19 vaccination, officials plan to implement an enhanced monitoring program in which vaccine recipients would complete surveys about adverse events, in addition to the traditional vaccine safety monitoring programs that already exist, officials said.
 

A version of this article originally appeared on Medscape.com.

States have begun preparing to distribute a COVID-19 vaccine if one is approved, a CDC official said today.

The CDC released guidance for states on Sept. 16 titled COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations. The document discusses vaccine ordering, storage, and handling and says that states should submit their plans for vaccine distribution to the agency by Oct. 16.

“Every jurisdiction is heavily involved right now in their plan development,” CDC official Janell Routh, MD, told the Advisory Committee on Immunization Practices during its Sept. 22 meeting. “It was really impressive to me that, even though the playbook only went out last week, states and jurisdictions have been thinking about this for quite some time.”

However, one committee member suggested that setting a deadline before more safety, efficacy, and storage information is known may be premature.

“I cannot imagine that we will actually know the final storage requirements for this vaccine by Oct. 16, which makes me a little concerned about finalizing state plans,” said Helen “Keipp” Talbot, MD, MPH, associate professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn. “We also don’t know the best populations yet when it comes to efficacy and safety.”

Dr. Routh said the CDC is asking states to plan on the basis of assumptions. “We know those plans will constantly be improving, changing, as we learn more information,” Dr. Routh said. States agreed to return a plan 30 days after the playbook was released, which is how the Oct. 16 deadline was established, she said.

States are encouraged to think broadly. Plans may include contingencies for a product that requires ultracold storage or for distributing more than one vaccine product, Dr. Routh said.

“One goal is to be ready on the first day that we can actually distribute vaccine,” Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases, said during the meeting. “Our colleagues in Operation Warp Speed say that they expect there will be vaccine as early as November, and therefore we need to be ready so there is no delay in distributing that vaccine. And that phase, that early phase, is really close upon us.”

Many states have already developed plans, and the CDC is providing technical assistance as needed to monitor the plans regularly, Dr. Routh said.
 

Key issues identified

From holding pilot meetings with five jurisdictions, officials learned that public confidence in the vaccine is among states’ greatest concerns, Dr. Routh said. In addition, distribution is resource intensive, and social distancing adds logistical complexity.

Specific guidance on whom to vaccinate in the early stages will smooth the process, officials suggested during the pilot meetings. For the first several weeks, vaccine doses may be limited to priority populations, such as health care workers.

“This interim playbook is a living document,” Dr. Routh emphasized. “We definitely plan to update the content regularly as we learn more information about what vaccines and when they will be released.”

During the early stages of COVID-19 vaccination, officials plan to implement an enhanced monitoring program in which vaccine recipients would complete surveys about adverse events, in addition to the traditional vaccine safety monitoring programs that already exist, officials said.
 

A version of this article originally appeared on Medscape.com.

Whether they realize it or not, dermatologists play a key role in the physical transformation of transgender patients, according to Doris Day, MD.

While clinical management of this patient population has historically been limited to experts in mental health, endocrinology, and select surgeons with experience in sex reassignment surgery, “what dermatologists provide on an aesthetic level through noninvasive or minimally invasive procedures can have a big impact in helping that transformation,” Dr. Day, of the department of dermatology at New York University Langone Health, said during the virtual annual Masters of Aesthetics Symposium. “But, we have to go through a transformation of sorts as well as we care for these patients, because we need to help them in the way that best matches their needs. We need to know about their mental health and the medicines they’re taking as well as their goals for their outcomes. If they’re working with surgeons for sex reassignment, we should have discussions with those clinicians as well.”

Gender-affirming hormone therapy is the primary medical intervention sought by transgender people, she said. This allows the acquisition of secondary sex characteristics more aligned with their gender identity. Feminizing hormone therapy affects the skin by reducing sebaceous gland activity, “which can lead to fewer acne breakouts and smaller pores but also cause drier skin,” Dr. Day said. “We can slow down the growth of body and facial hair and we can perform hair removal treatments. We see decreased male-pattern scalp hair loss, and we see smoother skin as the fat under the skin becomes thicker and the pores become smaller. We can also have increased pigment production, which is always a good thing.”

In a 2016 survey of 327 transgender individuals led by Dr. Day’s mentee, Brian A. Ginsberg, MD, and published in the Journal of the American Academy of Dermatology, most transgender women indicated that their face was most important to have changed, while for men it was the chest. Hair removal was the most common women’s facial procedure, followed by surgery then injectables, mostly performed by plastic surgeons.

Limitations of hormone therapy include the fact that it can take 2 or more years for associated changes to fully develop. “At least here in New York, patients want everything in a New York minute, so that’s always an issue,” she said. “We often recommend that patients wait at least 2 years after beginning hormone therapy before considering drastic feminization surgeries, but there are many options we have for them while they’re waiting for that. Even with hormone therapy, the bone structure of the face is unaffected, so we need to be artistic in creating a more feminized balance in order to help them physically match their gender to their identity.”

Noninvasive aesthetic procedures can compound the effects of hormone therapy, in addition to offering physical transformation beyond hormone therapy. She recalled assisting one of her patients transform from male to female. Over a period of 2 years, Dr. Day added Botox then Juvederm Voluma to the patient’s cheeks and chin, “and she started her transformation to a more feminized gender matching identity,” she said. Next came a hair transplant and the injection of more Voluma and fillers in the lips and cheeks on an as-needed basis.

“During one visit, I felt that we could still do more,” Dr. Day recalled. “She looked at me and said, ‘Actually, I feel so happy. This looks like me as I imagined I would look in my mind.’ I realized that my vision for her wasn’t the same as her vision for herself. She was thrilled with her transformation. I realized that as we see these patients, for all we learn about the science of gender transformation, the emotional aspects of our vision of what we can accomplish for our patients versus their vision of what their happiness level is may not entirely match. We have to be careful to help them celebrate their version of their femininity or masculinity, rather than trying to have our patients match what we think we can accomplish for them with our own sense of what femininity or masculinity is.”

Over time, Dr. Day said, the patient’s acne scars improved with fillers and microneedling treatments, and with the hormone therapy. “As we softened her appearance and as she made changes like the earrings that she wore and the hair style that she chose, she was in line with what her perception of her femininity was,” she said. “Little by little we’ve been watching her grow into her new self. It’s been a beautiful transformation. I was honored to be able to share in that journey with her.”

Dr. Day reported having no relevant financial disclosures.

[email protected]

Whether they realize it or not, dermatologists play a key role in the physical transformation of transgender patients, according to Doris Day, MD.

While clinical management of this patient population has historically been limited to experts in mental health, endocrinology, and select surgeons with experience in sex reassignment surgery, “what dermatologists provide on an aesthetic level through noninvasive or minimally invasive procedures can have a big impact in helping that transformation,” Dr. Day, of the department of dermatology at New York University Langone Health, said during the virtual annual Masters of Aesthetics Symposium. “But, we have to go through a transformation of sorts as well as we care for these patients, because we need to help them in the way that best matches their needs. We need to know about their mental health and the medicines they’re taking as well as their goals for their outcomes. If they’re working with surgeons for sex reassignment, we should have discussions with those clinicians as well.”

Gender-affirming hormone therapy is the primary medical intervention sought by transgender people, she said. This allows the acquisition of secondary sex characteristics more aligned with their gender identity. Feminizing hormone therapy affects the skin by reducing sebaceous gland activity, “which can lead to fewer acne breakouts and smaller pores but also cause drier skin,” Dr. Day said. “We can slow down the growth of body and facial hair and we can perform hair removal treatments. We see decreased male-pattern scalp hair loss, and we see smoother skin as the fat under the skin becomes thicker and the pores become smaller. We can also have increased pigment production, which is always a good thing.”

In a 2016 survey of 327 transgender individuals led by Dr. Day’s mentee, Brian A. Ginsberg, MD, and published in the Journal of the American Academy of Dermatology, most transgender women indicated that their face was most important to have changed, while for men it was the chest. Hair removal was the most common women’s facial procedure, followed by surgery then injectables, mostly performed by plastic surgeons.

Limitations of hormone therapy include the fact that it can take 2 or more years for associated changes to fully develop. “At least here in New York, patients want everything in a New York minute, so that’s always an issue,” she said. “We often recommend that patients wait at least 2 years after beginning hormone therapy before considering drastic feminization surgeries, but there are many options we have for them while they’re waiting for that. Even with hormone therapy, the bone structure of the face is unaffected, so we need to be artistic in creating a more feminized balance in order to help them physically match their gender to their identity.”

Noninvasive aesthetic procedures can compound the effects of hormone therapy, in addition to offering physical transformation beyond hormone therapy. She recalled assisting one of her patients transform from male to female. Over a period of 2 years, Dr. Day added Botox then Juvederm Voluma to the patient’s cheeks and chin, “and she started her transformation to a more feminized gender matching identity,” she said. Next came a hair transplant and the injection of more Voluma and fillers in the lips and cheeks on an as-needed basis.

“During one visit, I felt that we could still do more,” Dr. Day recalled. “She looked at me and said, ‘Actually, I feel so happy. This looks like me as I imagined I would look in my mind.’ I realized that my vision for her wasn’t the same as her vision for herself. She was thrilled with her transformation. I realized that as we see these patients, for all we learn about the science of gender transformation, the emotional aspects of our vision of what we can accomplish for our patients versus their vision of what their happiness level is may not entirely match. We have to be careful to help them celebrate their version of their femininity or masculinity, rather than trying to have our patients match what we think we can accomplish for them with our own sense of what femininity or masculinity is.”

Over time, Dr. Day said, the patient’s acne scars improved with fillers and microneedling treatments, and with the hormone therapy. “As we softened her appearance and as she made changes like the earrings that she wore and the hair style that she chose, she was in line with what her perception of her femininity was,” she said. “Little by little we’ve been watching her grow into her new self. It’s been a beautiful transformation. I was honored to be able to share in that journey with her.”

Dr. Day reported having no relevant financial disclosures.

[email protected]

Whether they realize it or not, dermatologists play a key role in the physical transformation of transgender patients, according to Doris Day, MD.

While clinical management of this patient population has historically been limited to experts in mental health, endocrinology, and select surgeons with experience in sex reassignment surgery, “what dermatologists provide on an aesthetic level through noninvasive or minimally invasive procedures can have a big impact in helping that transformation,” Dr. Day, of the department of dermatology at New York University Langone Health, said during the virtual annual Masters of Aesthetics Symposium. “But, we have to go through a transformation of sorts as well as we care for these patients, because we need to help them in the way that best matches their needs. We need to know about their mental health and the medicines they’re taking as well as their goals for their outcomes. If they’re working with surgeons for sex reassignment, we should have discussions with those clinicians as well.”

Gender-affirming hormone therapy is the primary medical intervention sought by transgender people, she said. This allows the acquisition of secondary sex characteristics more aligned with their gender identity. Feminizing hormone therapy affects the skin by reducing sebaceous gland activity, “which can lead to fewer acne breakouts and smaller pores but also cause drier skin,” Dr. Day said. “We can slow down the growth of body and facial hair and we can perform hair removal treatments. We see decreased male-pattern scalp hair loss, and we see smoother skin as the fat under the skin becomes thicker and the pores become smaller. We can also have increased pigment production, which is always a good thing.”

In a 2016 survey of 327 transgender individuals led by Dr. Day’s mentee, Brian A. Ginsberg, MD, and published in the Journal of the American Academy of Dermatology, most transgender women indicated that their face was most important to have changed, while for men it was the chest. Hair removal was the most common women’s facial procedure, followed by surgery then injectables, mostly performed by plastic surgeons.

Limitations of hormone therapy include the fact that it can take 2 or more years for associated changes to fully develop. “At least here in New York, patients want everything in a New York minute, so that’s always an issue,” she said. “We often recommend that patients wait at least 2 years after beginning hormone therapy before considering drastic feminization surgeries, but there are many options we have for them while they’re waiting for that. Even with hormone therapy, the bone structure of the face is unaffected, so we need to be artistic in creating a more feminized balance in order to help them physically match their gender to their identity.”

Noninvasive aesthetic procedures can compound the effects of hormone therapy, in addition to offering physical transformation beyond hormone therapy. She recalled assisting one of her patients transform from male to female. Over a period of 2 years, Dr. Day added Botox then Juvederm Voluma to the patient’s cheeks and chin, “and she started her transformation to a more feminized gender matching identity,” she said. Next came a hair transplant and the injection of more Voluma and fillers in the lips and cheeks on an as-needed basis.

“During one visit, I felt that we could still do more,” Dr. Day recalled. “She looked at me and said, ‘Actually, I feel so happy. This looks like me as I imagined I would look in my mind.’ I realized that my vision for her wasn’t the same as her vision for herself. She was thrilled with her transformation. I realized that as we see these patients, for all we learn about the science of gender transformation, the emotional aspects of our vision of what we can accomplish for our patients versus their vision of what their happiness level is may not entirely match. We have to be careful to help them celebrate their version of their femininity or masculinity, rather than trying to have our patients match what we think we can accomplish for them with our own sense of what femininity or masculinity is.”

Over time, Dr. Day said, the patient’s acne scars improved with fillers and microneedling treatments, and with the hormone therapy. “As we softened her appearance and as she made changes like the earrings that she wore and the hair style that she chose, she was in line with what her perception of her femininity was,” she said. “Little by little we’ve been watching her grow into her new self. It’s been a beautiful transformation. I was honored to be able to share in that journey with her.”

Dr. Day reported having no relevant financial disclosures.

[email protected]

Cosmetic laser procedures in darker skin types are associated with higher risks of pigmentary alterations and scarring, but can be performed safely with special considerations, according to Andrew F. Alexis, MD, MPH.

“With the devices and approaches we have today, we can achieve safe and favorable outcomes, as long as we keep in mind that there is no one-size-fits all approach,” Dr. Alexis, chair of the department of dermatology at Mount Sinai Morningside and Mount Sinai West, New York, said during the virtual annual Masters of Aesthetics Symposium. “Conservative parameters are key.”

According to 2018 data from the American Society for Aesthetic Plastic Surgery, 30% of all aesthetic procedures in the United States are being performed on self-identified non-White racial ethnic groups. “This is projected to continue to increase given demographic changes as well as changes in our technologies and approaches to aesthetic procedures that allow for safer outcomes across a more diverse range of patients,” said Dr. Alexis, professor of dermatology at Icahn School of Medicine at Mount Sinai, New York. “That being said, even though we have many safe and effective options for all skin types today, we still have to consider that on the whole, there are higher risks of pigmentary and scarring complications when we perform most of our aesthetic procedures in darker skin types. The concept of limiting the degree of injury associated with a procedure remains paramount. Even when we pick the correct device for a give patient’s skin type, if our parameters aren’t optimal, or if our technique isn’t optimal, we can still end up with pigmentary and scarring complications.”

He offered key principles for maximining safety and optimal outcomes:

Know your device. Understand the range of parameters that are safe and effective for the given skin types that you see in your practice. “Don’t just rely on what the manufacturer provides in the manual, because you could have safe parameters as directed by the manual but undertreat some patients because the settings are too conservative,” Dr. Alexis said. “On the other hand, there might be scenarios where following recommended settings for a specific skin type might still wind up with a complication. Doing test spots is key in order to master the device that you are using.”

Know your patient. Don’t assume that you know a patient’s skin phototype or ancestry when that person first presents. “When we do that, we can arrive at erroneous conclusions with respect to phototype and with respect to ancestral background, and with respect to risk of pigmentary and scarring complications,” he said. “Treat your patient as an individual; no cookie-cutter responses, no assumptions.” He makes it a point to ask patients about their ancestry and about how their skin responds to sunlight in terms of tanning ability and to injury and inflammation such as insect bites, acne, and minor abrasions. “What happens to their skin when those things happen?” Dr. Alexis said. “Do they have a tendency to hyperpigment or not? You can easily ask for that or look for evidence of that on their skin. Similarly, asking about a personal or family history of keloids or hypertrophic scars is helpful in determining an overall risk assessment for a patient before you proceed with a given procedure.”

Recognize differences in preferred treatment options and parameters. Often, less is more. For example, he said, with laser hair removal, strive for longer wavelengths, lower fluences, longer pulse durations, and increased epidermal cooling. A study from 2002 in the Journal of the American Academy of Dermatology showed that the maximum tolerated fluence of type VI skin with the 1064 Nd: YAG laser was 50 J/cm².

According to Dr. Alexis, nonablative fractional resurfacing “set the stage for being able to have safe outcomes for all skin types,” he said. “That being said, the higher the skin phototype, the higher the incidence of postinflammatory hyperpigmentation. How can we reduce this? The most important parameter is the treatment density, even though in a retrospective review from my center, high energies were associated with higher PIH rates too. Using conservative treatment densities lowers the risk of hyperpigmentation.”

Prophylactic use of hydroquinone prior to resurfacing with fractional lasers is another way to minimize the risk of postinflammatory hyperpigmentation. With this approach, Dr. Alexis asks patients to apply hydroquinone two weeks before treatment and for at least 4 weeks after. “Sun protection is key,” he said. “But when taking all of this into account, using conservative treatment densities in the range of 11%-20% coverage with a 1,550-nm Erbium-doped fractional laser, you can get favorable outcomes across skin types. But sometimes you can wind up with complications even if you do the right things.” He recalled a patient he treated for acne scarring and atrophic scars. After three treatments with the nonablative fractional 1,550-nm Erbium-doped laser set at level 4 (11% coverage), the patient developed hyperpigmentation of the treatment area. Dr. Alexis chose to continue treatment “with a few tweaks to reduce the risk of further hyperpigmentation,” he said. “I reduced the treatment density and the number of passes by half, so that the total energy delivered was halved. I also increased the concentration of hydroquinone from 4% to 6%. With that, the postinflammatory hyperpigmentation resolved.”

Another tool for resurfacing is the microsecond 1,064-nm Nd:YAG laser. “No anesthesia is required, there’s minimal down time, and you can treat all skin types,” Dr. Alexis said. “No pre- or posttreatment prophylaxis with bleaching agents are necessary, but multiple laser treatment sessions are required in order to achieve clinically meaningful results.” His approach to treating types V and VI skin involves a 1,064-nm Nd:YAG laser with a 5-mm spot size, a 0.3-microsecond pulse duration, a fluence of 12-14 J/cm², a repetition rate of 5-8 Hz, 1,000-2,000 pulses per cosmetic unit, and avoidance of pulse stacking. He generally performs 4-6 treatment sessions 2-6 weeks apart.

An additional option for resurfacing is the 650-microsecond 1,064-nm Nd:YAG laser. The recommend fluence in skin of color is 14-21 J/cm^2. A recent review article in the Journal of Drugs in Dermatology described clinical experience using this device for a wide range of conditions in darker skin types, including acne, hyperpigmentation, and melasma.

A more recent approach is using fractional radiofrequency devices, especially those that feature coated pin tips. These tips “protect the epidermis from heat injury and deliver heat to the deeper dermis where we want it, and minimize the risk to the epidermis,” Dr. Alexis said. In a 2018 study in the Journal of Drugs in Dermatology of 35 patients with skin type VI, participants received three sessions of facial treatments, 4 weeks apart using a fractional RF device with 24-pin coated tip. The researchers found that the regimen was safe and effective, and that it resulted in improved wrinkles, acne scars, and overall skin appearance.

Dr. Alexis disclosed that he has served as an adviser to or has received consulting fees from Leo, Novartis, Menlo, Galderma, Pfizer, Sanofi-Regeneron, Dermavant, Unilever, Celgene, Beiersdorf, Valeant, L’Oreal, BMS, Scientis, Bausch Health, UCB, Foamix, and Cassiopea.

[email protected]

Cosmetic laser procedures in darker skin types are associated with higher risks of pigmentary alterations and scarring, but can be performed safely with special considerations, according to Andrew F. Alexis, MD, MPH.

“With the devices and approaches we have today, we can achieve safe and favorable outcomes, as long as we keep in mind that there is no one-size-fits all approach,” Dr. Alexis, chair of the department of dermatology at Mount Sinai Morningside and Mount Sinai West, New York, said during the virtual annual Masters of Aesthetics Symposium. “Conservative parameters are key.”

According to 2018 data from the American Society for Aesthetic Plastic Surgery, 30% of all aesthetic procedures in the United States are being performed on self-identified non-White racial ethnic groups. “This is projected to continue to increase given demographic changes as well as changes in our technologies and approaches to aesthetic procedures that allow for safer outcomes across a more diverse range of patients,” said Dr. Alexis, professor of dermatology at Icahn School of Medicine at Mount Sinai, New York. “That being said, even though we have many safe and effective options for all skin types today, we still have to consider that on the whole, there are higher risks of pigmentary and scarring complications when we perform most of our aesthetic procedures in darker skin types. The concept of limiting the degree of injury associated with a procedure remains paramount. Even when we pick the correct device for a give patient’s skin type, if our parameters aren’t optimal, or if our technique isn’t optimal, we can still end up with pigmentary and scarring complications.”

He offered key principles for maximining safety and optimal outcomes:

Know your device. Understand the range of parameters that are safe and effective for the given skin types that you see in your practice. “Don’t just rely on what the manufacturer provides in the manual, because you could have safe parameters as directed by the manual but undertreat some patients because the settings are too conservative,” Dr. Alexis said. “On the other hand, there might be scenarios where following recommended settings for a specific skin type might still wind up with a complication. Doing test spots is key in order to master the device that you are using.”

Know your patient. Don’t assume that you know a patient’s skin phototype or ancestry when that person first presents. “When we do that, we can arrive at erroneous conclusions with respect to phototype and with respect to ancestral background, and with respect to risk of pigmentary and scarring complications,” he said. “Treat your patient as an individual; no cookie-cutter responses, no assumptions.” He makes it a point to ask patients about their ancestry and about how their skin responds to sunlight in terms of tanning ability and to injury and inflammation such as insect bites, acne, and minor abrasions. “What happens to their skin when those things happen?” Dr. Alexis said. “Do they have a tendency to hyperpigment or not? You can easily ask for that or look for evidence of that on their skin. Similarly, asking about a personal or family history of keloids or hypertrophic scars is helpful in determining an overall risk assessment for a patient before you proceed with a given procedure.”

Recognize differences in preferred treatment options and parameters. Often, less is more. For example, he said, with laser hair removal, strive for longer wavelengths, lower fluences, longer pulse durations, and increased epidermal cooling. A study from 2002 in the Journal of the American Academy of Dermatology showed that the maximum tolerated fluence of type VI skin with the 1064 Nd: YAG laser was 50 J/cm².

According to Dr. Alexis, nonablative fractional resurfacing “set the stage for being able to have safe outcomes for all skin types,” he said. “That being said, the higher the skin phototype, the higher the incidence of postinflammatory hyperpigmentation. How can we reduce this? The most important parameter is the treatment density, even though in a retrospective review from my center, high energies were associated with higher PIH rates too. Using conservative treatment densities lowers the risk of hyperpigmentation.”

Prophylactic use of hydroquinone prior to resurfacing with fractional lasers is another way to minimize the risk of postinflammatory hyperpigmentation. With this approach, Dr. Alexis asks patients to apply hydroquinone two weeks before treatment and for at least 4 weeks after. “Sun protection is key,” he said. “But when taking all of this into account, using conservative treatment densities in the range of 11%-20% coverage with a 1,550-nm Erbium-doped fractional laser, you can get favorable outcomes across skin types. But sometimes you can wind up with complications even if you do the right things.” He recalled a patient he treated for acne scarring and atrophic scars. After three treatments with the nonablative fractional 1,550-nm Erbium-doped laser set at level 4 (11% coverage), the patient developed hyperpigmentation of the treatment area. Dr. Alexis chose to continue treatment “with a few tweaks to reduce the risk of further hyperpigmentation,” he said. “I reduced the treatment density and the number of passes by half, so that the total energy delivered was halved. I also increased the concentration of hydroquinone from 4% to 6%. With that, the postinflammatory hyperpigmentation resolved.”

Another tool for resurfacing is the microsecond 1,064-nm Nd:YAG laser. “No anesthesia is required, there’s minimal down time, and you can treat all skin types,” Dr. Alexis said. “No pre- or posttreatment prophylaxis with bleaching agents are necessary, but multiple laser treatment sessions are required in order to achieve clinically meaningful results.” His approach to treating types V and VI skin involves a 1,064-nm Nd:YAG laser with a 5-mm spot size, a 0.3-microsecond pulse duration, a fluence of 12-14 J/cm², a repetition rate of 5-8 Hz, 1,000-2,000 pulses per cosmetic unit, and avoidance of pulse stacking. He generally performs 4-6 treatment sessions 2-6 weeks apart.

An additional option for resurfacing is the 650-microsecond 1,064-nm Nd:YAG laser. The recommend fluence in skin of color is 14-21 J/cm^2. A recent review article in the Journal of Drugs in Dermatology described clinical experience using this device for a wide range of conditions in darker skin types, including acne, hyperpigmentation, and melasma.

A more recent approach is using fractional radiofrequency devices, especially those that feature coated pin tips. These tips “protect the epidermis from heat injury and deliver heat to the deeper dermis where we want it, and minimize the risk to the epidermis,” Dr. Alexis said. In a 2018 study in the Journal of Drugs in Dermatology of 35 patients with skin type VI, participants received three sessions of facial treatments, 4 weeks apart using a fractional RF device with 24-pin coated tip. The researchers found that the regimen was safe and effective, and that it resulted in improved wrinkles, acne scars, and overall skin appearance.

Dr. Alexis disclosed that he has served as an adviser to or has received consulting fees from Leo, Novartis, Menlo, Galderma, Pfizer, Sanofi-Regeneron, Dermavant, Unilever, Celgene, Beiersdorf, Valeant, L’Oreal, BMS, Scientis, Bausch Health, UCB, Foamix, and Cassiopea.

[email protected]

Cosmetic laser procedures in darker skin types are associated with higher risks of pigmentary alterations and scarring, but can be performed safely with special considerations, according to Andrew F. Alexis, MD, MPH.

“With the devices and approaches we have today, we can achieve safe and favorable outcomes, as long as we keep in mind that there is no one-size-fits all approach,” Dr. Alexis, chair of the department of dermatology at Mount Sinai Morningside and Mount Sinai West, New York, said during the virtual annual Masters of Aesthetics Symposium. “Conservative parameters are key.”

According to 2018 data from the American Society for Aesthetic Plastic Surgery, 30% of all aesthetic procedures in the United States are being performed on self-identified non-White racial ethnic groups. “This is projected to continue to increase given demographic changes as well as changes in our technologies and approaches to aesthetic procedures that allow for safer outcomes across a more diverse range of patients,” said Dr. Alexis, professor of dermatology at Icahn School of Medicine at Mount Sinai, New York. “That being said, even though we have many safe and effective options for all skin types today, we still have to consider that on the whole, there are higher risks of pigmentary and scarring complications when we perform most of our aesthetic procedures in darker skin types. The concept of limiting the degree of injury associated with a procedure remains paramount. Even when we pick the correct device for a give patient’s skin type, if our parameters aren’t optimal, or if our technique isn’t optimal, we can still end up with pigmentary and scarring complications.”

He offered key principles for maximining safety and optimal outcomes:

Know your device. Understand the range of parameters that are safe and effective for the given skin types that you see in your practice. “Don’t just rely on what the manufacturer provides in the manual, because you could have safe parameters as directed by the manual but undertreat some patients because the settings are too conservative,” Dr. Alexis said. “On the other hand, there might be scenarios where following recommended settings for a specific skin type might still wind up with a complication. Doing test spots is key in order to master the device that you are using.”

Know your patient. Don’t assume that you know a patient’s skin phototype or ancestry when that person first presents. “When we do that, we can arrive at erroneous conclusions with respect to phototype and with respect to ancestral background, and with respect to risk of pigmentary and scarring complications,” he said. “Treat your patient as an individual; no cookie-cutter responses, no assumptions.” He makes it a point to ask patients about their ancestry and about how their skin responds to sunlight in terms of tanning ability and to injury and inflammation such as insect bites, acne, and minor abrasions. “What happens to their skin when those things happen?” Dr. Alexis said. “Do they have a tendency to hyperpigment or not? You can easily ask for that or look for evidence of that on their skin. Similarly, asking about a personal or family history of keloids or hypertrophic scars is helpful in determining an overall risk assessment for a patient before you proceed with a given procedure.”

Recognize differences in preferred treatment options and parameters. Often, less is more. For example, he said, with laser hair removal, strive for longer wavelengths, lower fluences, longer pulse durations, and increased epidermal cooling. A study from 2002 in the Journal of the American Academy of Dermatology showed that the maximum tolerated fluence of type VI skin with the 1064 Nd: YAG laser was 50 J/cm².

According to Dr. Alexis, nonablative fractional resurfacing “set the stage for being able to have safe outcomes for all skin types,” he said. “That being said, the higher the skin phototype, the higher the incidence of postinflammatory hyperpigmentation. How can we reduce this? The most important parameter is the treatment density, even though in a retrospective review from my center, high energies were associated with higher PIH rates too. Using conservative treatment densities lowers the risk of hyperpigmentation.”

Prophylactic use of hydroquinone prior to resurfacing with fractional lasers is another way to minimize the risk of postinflammatory hyperpigmentation. With this approach, Dr. Alexis asks patients to apply hydroquinone two weeks before treatment and for at least 4 weeks after. “Sun protection is key,” he said. “But when taking all of this into account, using conservative treatment densities in the range of 11%-20% coverage with a 1,550-nm Erbium-doped fractional laser, you can get favorable outcomes across skin types. But sometimes you can wind up with complications even if you do the right things.” He recalled a patient he treated for acne scarring and atrophic scars. After three treatments with the nonablative fractional 1,550-nm Erbium-doped laser set at level 4 (11% coverage), the patient developed hyperpigmentation of the treatment area. Dr. Alexis chose to continue treatment “with a few tweaks to reduce the risk of further hyperpigmentation,” he said. “I reduced the treatment density and the number of passes by half, so that the total energy delivered was halved. I also increased the concentration of hydroquinone from 4% to 6%. With that, the postinflammatory hyperpigmentation resolved.”

Another tool for resurfacing is the microsecond 1,064-nm Nd:YAG laser. “No anesthesia is required, there’s minimal down time, and you can treat all skin types,” Dr. Alexis said. “No pre- or posttreatment prophylaxis with bleaching agents are necessary, but multiple laser treatment sessions are required in order to achieve clinically meaningful results.” His approach to treating types V and VI skin involves a 1,064-nm Nd:YAG laser with a 5-mm spot size, a 0.3-microsecond pulse duration, a fluence of 12-14 J/cm², a repetition rate of 5-8 Hz, 1,000-2,000 pulses per cosmetic unit, and avoidance of pulse stacking. He generally performs 4-6 treatment sessions 2-6 weeks apart.

An additional option for resurfacing is the 650-microsecond 1,064-nm Nd:YAG laser. The recommend fluence in skin of color is 14-21 J/cm^2. A recent review article in the Journal of Drugs in Dermatology described clinical experience using this device for a wide range of conditions in darker skin types, including acne, hyperpigmentation, and melasma.

A more recent approach is using fractional radiofrequency devices, especially those that feature coated pin tips. These tips “protect the epidermis from heat injury and deliver heat to the deeper dermis where we want it, and minimize the risk to the epidermis,” Dr. Alexis said. In a 2018 study in the Journal of Drugs in Dermatology of 35 patients with skin type VI, participants received three sessions of facial treatments, 4 weeks apart using a fractional RF device with 24-pin coated tip. The researchers found that the regimen was safe and effective, and that it resulted in improved wrinkles, acne scars, and overall skin appearance.

Dr. Alexis disclosed that he has served as an adviser to or has received consulting fees from Leo, Novartis, Menlo, Galderma, Pfizer, Sanofi-Regeneron, Dermavant, Unilever, Celgene, Beiersdorf, Valeant, L’Oreal, BMS, Scientis, Bausch Health, UCB, Foamix, and Cassiopea.

[email protected]

Patients with advanced melanoma who have progressed on anti–programmed death 1/PD-ligand 1 (PD-L1) immunotherapy could substantially extend their overall survival (OS) with a combination of the tyrosine kinase inhibitor lenvatinib (Lenvima) and pembrolizumab (Keytruda), suggests an open-label, single arm study.

The research was presented Sept. 19 at the European Society for Medical Oncology Virtual Congress 2020.

In LEAP-004 trial, over 100 patients with stage 3 or 4 melanoma who had progressed after immunotherapy were given lenvatinib plus pembrolizumab, which yielded a median progression-free survival (PFS) of more than 4 months and a median OS of more than a year. Median follow-up was 12 months.

Presenting the findings, Ana Maria Arance Fernandez, MD, PhD, Hospital Clínic de Barcelona, Spain, said lenvatinib plus pembrolizumab has “promising” antitumor activity in patients with advanced melanoma with confirmed progression on a PD-1 inhibitor given alone or in combination. “These results are encouraging given the stringent definition of progression on prior anti-PD-1 therapy and the enrollment of poor-risk patients.”

Dr. Arance Fernandez added that “these data support lenvatinib plus pembrolizumab as a potential treatment regimen for this population of high unmet medical need.”

Bartosz Chmielowski, MD, PhD, Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, who was not involved in the study, discussed the findings.

He highlighted that the patients were not randomly assigned in LEAP-004, with all of them receiving the same therapy.

Nevertheless, the response rate was “quite impressive for this patient population.”

He also drew comparison with previous data with nivolumab (Opdivo) alone or in combination with ipilimumab (Yervoy) in a similar population, noting that the overall survival was less than half that seen in the current trial, “which makes these results even more important.”

“It tells us that this combination might be an option with disease progression on anti-PD-1,” Dr. Chmielowski noted.

Dr. Arance Fernandez pointed out that patients with advanced melanoma who progress on standard-of-care treatment with anti-PD-1 therapy or a cytotoxic T-lymphocyte–associated protein 4 (CTLA4) inhibitor plus anti-PD-1 “have very limited therapeutic options available and there is no approved regimen in this indication.”
 

Response rate, PFS, and OS

Previous studies have indicated that adding an anti-PD-1 drug to lenvatinib achieves superior antitumor activity than either treatment alone, with promising results in phase 1/2b data in pretreated metastatic melanoma.

LEAP-004 therefore enrolled patients with unresectable stage 3 or 4 melanoma, who had disease progression within 12 weeks of their last dose of anti-PD-(L)1 therapy either alone or with a CTLA4 inhibitor. There was no limit on the number of prior treatments.

The patients received pembrolizumab 200 mg IV for up to 35 cycles plus lenvatinib 20 mg daily until progression, unacceptable toxicity, or patient or physician decision.

They were imaged at baseline and every 9 weeks through to week 54, then every 12 weeks until week 102, and then every 24 weeks.

From February to September 2019, 103 patients were enrolled, all of whom received at least one dose of lenvatinib plus pembrolizumab. The median age of the patients was 63 years, and 53.4% were male.

Dr. Arance Fernandez pointed out that this was a high-risk population, with 20.4% having a lactate dehydrogenase level twice the upper limit of normal and 14.6% having brain metastasis, while the median sum of target lesions was 100 mm.

A BRAFv600 mutation was identified in 36.9% of patients, and 64.1% were PD-L1 positive.

Nearly one third (28.2%) had received a prior anti-CTLA4 plus anti-PD-(L)1 combination, and 19.5% had undergone four or more prior lines of therapy.

The overall response rate to lenvatinib plus pembrolizumab was 21.4%, with 1.9% having a complete response and 19.4% a partial response. This was seen across subgroups, including by age and disease stage.

Dr. Arance Fernandez said the overall response rate was even higher in patients who had previously been treated with an anti-CTLA4 plus anti-PD-(L)1 combination, at 31%.

However, Dr. Chmielowski warned that “we must interpret this result with caution since only 29 patients were in this subpopulation.”

The median duration of response (per blinded independent committee review) across the study population was 6.3 months, with 72.6% still responding at 6 months.

The median PFS was 4.2 months with the combination therapy, with 41.7% of patients progression free at 6 months, and 26.2% at 9 months.

Median overall survival was 13.9 months, with 77.3% of patients still alive at 6 months and 65.4% alive at 9 months.

Although 96.1% of patients experienced at least one treatment-related adverse event of any grade, only 44.7% had grade 3 or higher events, and only in 7.8% of cases did that lead to treatment discontinuation.

The most common adverse events were hypertension (56.3%), diarrhea (35.9%), nausea (34%), and hypothyroidism (33%), although, in the vast majority of cases, these events were grade 1 or 2.
 

LEAP presents challenges

Dr. Chmielowski would like to see treatment in this setting individualized somehow.

“It will be also important to come up with personalized immunotherapy so that, based on the mechanism of resistance in patient populations, we would be able to choose the subsequent treatments,” he commented.

Dr. Arance Fernandez explained that lenvatinib inhibits multiple tyrosine kinases involved in angiogenesis, cell proliferation, and immune modulation, and has demonstrated immunomodulatory activity in the tumor microenvironment.

However, Dr. Arance Fernandez noted that, as resistance to immunotherapy is “multifactorial,” it may be that a combination treatment will be more effective in these patients.

The study was funded by Merck. Dr. Arance Fernandez has financial ties to Merck and multiple other drug companies. Dr. Chmielowski has financial ties to Merck Serono and multiple other companies.  

This article first appeared on Medscape.com.

Patients with advanced melanoma who have progressed on anti–programmed death 1/PD-ligand 1 (PD-L1) immunotherapy could substantially extend their overall survival (OS) with a combination of the tyrosine kinase inhibitor lenvatinib (Lenvima) and pembrolizumab (Keytruda), suggests an open-label, single arm study.

The research was presented Sept. 19 at the European Society for Medical Oncology Virtual Congress 2020.

In LEAP-004 trial, over 100 patients with stage 3 or 4 melanoma who had progressed after immunotherapy were given lenvatinib plus pembrolizumab, which yielded a median progression-free survival (PFS) of more than 4 months and a median OS of more than a year. Median follow-up was 12 months.

Presenting the findings, Ana Maria Arance Fernandez, MD, PhD, Hospital Clínic de Barcelona, Spain, said lenvatinib plus pembrolizumab has “promising” antitumor activity in patients with advanced melanoma with confirmed progression on a PD-1 inhibitor given alone or in combination. “These results are encouraging given the stringent definition of progression on prior anti-PD-1 therapy and the enrollment of poor-risk patients.”

Dr. Arance Fernandez added that “these data support lenvatinib plus pembrolizumab as a potential treatment regimen for this population of high unmet medical need.”

Bartosz Chmielowski, MD, PhD, Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, who was not involved in the study, discussed the findings.

He highlighted that the patients were not randomly assigned in LEAP-004, with all of them receiving the same therapy.

Nevertheless, the response rate was “quite impressive for this patient population.”

He also drew comparison with previous data with nivolumab (Opdivo) alone or in combination with ipilimumab (Yervoy) in a similar population, noting that the overall survival was less than half that seen in the current trial, “which makes these results even more important.”

“It tells us that this combination might be an option with disease progression on anti-PD-1,” Dr. Chmielowski noted.

Dr. Arance Fernandez pointed out that patients with advanced melanoma who progress on standard-of-care treatment with anti-PD-1 therapy or a cytotoxic T-lymphocyte–associated protein 4 (CTLA4) inhibitor plus anti-PD-1 “have very limited therapeutic options available and there is no approved regimen in this indication.”
 

Response rate, PFS, and OS

Previous studies have indicated that adding an anti-PD-1 drug to lenvatinib achieves superior antitumor activity than either treatment alone, with promising results in phase 1/2b data in pretreated metastatic melanoma.

LEAP-004 therefore enrolled patients with unresectable stage 3 or 4 melanoma, who had disease progression within 12 weeks of their last dose of anti-PD-(L)1 therapy either alone or with a CTLA4 inhibitor. There was no limit on the number of prior treatments.

The patients received pembrolizumab 200 mg IV for up to 35 cycles plus lenvatinib 20 mg daily until progression, unacceptable toxicity, or patient or physician decision.

They were imaged at baseline and every 9 weeks through to week 54, then every 12 weeks until week 102, and then every 24 weeks.

From February to September 2019, 103 patients were enrolled, all of whom received at least one dose of lenvatinib plus pembrolizumab. The median age of the patients was 63 years, and 53.4% were male.

Dr. Arance Fernandez pointed out that this was a high-risk population, with 20.4% having a lactate dehydrogenase level twice the upper limit of normal and 14.6% having brain metastasis, while the median sum of target lesions was 100 mm.

A BRAFv600 mutation was identified in 36.9% of patients, and 64.1% were PD-L1 positive.

Nearly one third (28.2%) had received a prior anti-CTLA4 plus anti-PD-(L)1 combination, and 19.5% had undergone four or more prior lines of therapy.

The overall response rate to lenvatinib plus pembrolizumab was 21.4%, with 1.9% having a complete response and 19.4% a partial response. This was seen across subgroups, including by age and disease stage.

Dr. Arance Fernandez said the overall response rate was even higher in patients who had previously been treated with an anti-CTLA4 plus anti-PD-(L)1 combination, at 31%.

However, Dr. Chmielowski warned that “we must interpret this result with caution since only 29 patients were in this subpopulation.”

The median duration of response (per blinded independent committee review) across the study population was 6.3 months, with 72.6% still responding at 6 months.

The median PFS was 4.2 months with the combination therapy, with 41.7% of patients progression free at 6 months, and 26.2% at 9 months.

Median overall survival was 13.9 months, with 77.3% of patients still alive at 6 months and 65.4% alive at 9 months.

Although 96.1% of patients experienced at least one treatment-related adverse event of any grade, only 44.7% had grade 3 or higher events, and only in 7.8% of cases did that lead to treatment discontinuation.

The most common adverse events were hypertension (56.3%), diarrhea (35.9%), nausea (34%), and hypothyroidism (33%), although, in the vast majority of cases, these events were grade 1 or 2.
 

LEAP presents challenges

Dr. Chmielowski would like to see treatment in this setting individualized somehow.

“It will be also important to come up with personalized immunotherapy so that, based on the mechanism of resistance in patient populations, we would be able to choose the subsequent treatments,” he commented.

Dr. Arance Fernandez explained that lenvatinib inhibits multiple tyrosine kinases involved in angiogenesis, cell proliferation, and immune modulation, and has demonstrated immunomodulatory activity in the tumor microenvironment.

However, Dr. Arance Fernandez noted that, as resistance to immunotherapy is “multifactorial,” it may be that a combination treatment will be more effective in these patients.

The study was funded by Merck. Dr. Arance Fernandez has financial ties to Merck and multiple other drug companies. Dr. Chmielowski has financial ties to Merck Serono and multiple other companies.  

This article first appeared on Medscape.com.

Patients with advanced melanoma who have progressed on anti–programmed death 1/PD-ligand 1 (PD-L1) immunotherapy could substantially extend their overall survival (OS) with a combination of the tyrosine kinase inhibitor lenvatinib (Lenvima) and pembrolizumab (Keytruda), suggests an open-label, single arm study.

The research was presented Sept. 19 at the European Society for Medical Oncology Virtual Congress 2020.

In LEAP-004 trial, over 100 patients with stage 3 or 4 melanoma who had progressed after immunotherapy were given lenvatinib plus pembrolizumab, which yielded a median progression-free survival (PFS) of more than 4 months and a median OS of more than a year. Median follow-up was 12 months.

Presenting the findings, Ana Maria Arance Fernandez, MD, PhD, Hospital Clínic de Barcelona, Spain, said lenvatinib plus pembrolizumab has “promising” antitumor activity in patients with advanced melanoma with confirmed progression on a PD-1 inhibitor given alone or in combination. “These results are encouraging given the stringent definition of progression on prior anti-PD-1 therapy and the enrollment of poor-risk patients.”

Dr. Arance Fernandez added that “these data support lenvatinib plus pembrolizumab as a potential treatment regimen for this population of high unmet medical need.”

Bartosz Chmielowski, MD, PhD, Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, who was not involved in the study, discussed the findings.

He highlighted that the patients were not randomly assigned in LEAP-004, with all of them receiving the same therapy.

Nevertheless, the response rate was “quite impressive for this patient population.”

He also drew comparison with previous data with nivolumab (Opdivo) alone or in combination with ipilimumab (Yervoy) in a similar population, noting that the overall survival was less than half that seen in the current trial, “which makes these results even more important.”

“It tells us that this combination might be an option with disease progression on anti-PD-1,” Dr. Chmielowski noted.

Dr. Arance Fernandez pointed out that patients with advanced melanoma who progress on standard-of-care treatment with anti-PD-1 therapy or a cytotoxic T-lymphocyte–associated protein 4 (CTLA4) inhibitor plus anti-PD-1 “have very limited therapeutic options available and there is no approved regimen in this indication.”
 

Response rate, PFS, and OS

Previous studies have indicated that adding an anti-PD-1 drug to lenvatinib achieves superior antitumor activity than either treatment alone, with promising results in phase 1/2b data in pretreated metastatic melanoma.

LEAP-004 therefore enrolled patients with unresectable stage 3 or 4 melanoma, who had disease progression within 12 weeks of their last dose of anti-PD-(L)1 therapy either alone or with a CTLA4 inhibitor. There was no limit on the number of prior treatments.

The patients received pembrolizumab 200 mg IV for up to 35 cycles plus lenvatinib 20 mg daily until progression, unacceptable toxicity, or patient or physician decision.

They were imaged at baseline and every 9 weeks through to week 54, then every 12 weeks until week 102, and then every 24 weeks.

From February to September 2019, 103 patients were enrolled, all of whom received at least one dose of lenvatinib plus pembrolizumab. The median age of the patients was 63 years, and 53.4% were male.

Dr. Arance Fernandez pointed out that this was a high-risk population, with 20.4% having a lactate dehydrogenase level twice the upper limit of normal and 14.6% having brain metastasis, while the median sum of target lesions was 100 mm.

A BRAFv600 mutation was identified in 36.9% of patients, and 64.1% were PD-L1 positive.

Nearly one third (28.2%) had received a prior anti-CTLA4 plus anti-PD-(L)1 combination, and 19.5% had undergone four or more prior lines of therapy.

The overall response rate to lenvatinib plus pembrolizumab was 21.4%, with 1.9% having a complete response and 19.4% a partial response. This was seen across subgroups, including by age and disease stage.

Dr. Arance Fernandez said the overall response rate was even higher in patients who had previously been treated with an anti-CTLA4 plus anti-PD-(L)1 combination, at 31%.

However, Dr. Chmielowski warned that “we must interpret this result with caution since only 29 patients were in this subpopulation.”

The median duration of response (per blinded independent committee review) across the study population was 6.3 months, with 72.6% still responding at 6 months.

The median PFS was 4.2 months with the combination therapy, with 41.7% of patients progression free at 6 months, and 26.2% at 9 months.

Median overall survival was 13.9 months, with 77.3% of patients still alive at 6 months and 65.4% alive at 9 months.

Although 96.1% of patients experienced at least one treatment-related adverse event of any grade, only 44.7% had grade 3 or higher events, and only in 7.8% of cases did that lead to treatment discontinuation.

The most common adverse events were hypertension (56.3%), diarrhea (35.9%), nausea (34%), and hypothyroidism (33%), although, in the vast majority of cases, these events were grade 1 or 2.
 

LEAP presents challenges

Dr. Chmielowski would like to see treatment in this setting individualized somehow.

“It will be also important to come up with personalized immunotherapy so that, based on the mechanism of resistance in patient populations, we would be able to choose the subsequent treatments,” he commented.

Dr. Arance Fernandez explained that lenvatinib inhibits multiple tyrosine kinases involved in angiogenesis, cell proliferation, and immune modulation, and has demonstrated immunomodulatory activity in the tumor microenvironment.

However, Dr. Arance Fernandez noted that, as resistance to immunotherapy is “multifactorial,” it may be that a combination treatment will be more effective in these patients.

The study was funded by Merck. Dr. Arance Fernandez has financial ties to Merck and multiple other drug companies. Dr. Chmielowski has financial ties to Merck Serono and multiple other companies.  

This article first appeared on Medscape.com.

The companies behind three major COVID-19 vaccines in development released the protocols of their trials, outlining their expectations for participant enrollment, benchmarks for vaccine efficacy, and more details about the makeup of each product.

Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.

On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.

The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.

“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
 

AstraZeneca takes a shot at transparency

The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.

The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.

“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.

“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
 

Moderna methodology

The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.

A statement that was requested from ModernaTX was not received by press time.
 

Pfizer protocol

In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.

Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.

“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.

“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.

If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.

Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
 

A positive move

“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.

“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.

Kruse has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The companies behind three major COVID-19 vaccines in development released the protocols of their trials, outlining their expectations for participant enrollment, benchmarks for vaccine efficacy, and more details about the makeup of each product.

Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.

On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.

The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.

“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
 

AstraZeneca takes a shot at transparency

The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.

The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.

“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.

“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
 

Moderna methodology

The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.

A statement that was requested from ModernaTX was not received by press time.
 

Pfizer protocol

In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.

Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.

“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.

“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.

If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.

Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
 

A positive move

“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.

“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.

Kruse has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

The companies behind three major COVID-19 vaccines in development released the protocols of their trials, outlining their expectations for participant enrollment, benchmarks for vaccine efficacy, and more details about the makeup of each product.

Typically, manufacturers guard the specifics of preclinical vaccine trials. This rare move follows calls for greater transparency. For example, the American Medical Association wrote a letter in late August asking the Food and Drug Administration to keep physicians informed of their COVID-19 vaccine review process.

On September 17, ModernaTx released the phase 3 trial protocol for its mRNA-1273 SARS-CoV-2 vaccine. In short order, on September 19, Pfizer/BioNTech shared their phase 1/2/3 trial vaccine protocol. AstraZeneca, which is developing a vaccine along with Oxford University, also released its protocol.

The AstraZeneca vaccine trial made headlines recently for having to be temporarily halted because of unexpected illnesses that arose in two participants, according to the New York Times and other sources.

“I applaud the release of the clinical trial protocols by the companies. The public trust in any COVID-19 vaccine is paramount, especially given the fast timeline and perceived political pressures of these candidates,” Robert Kruse, MD, PhD, told Medscape Medical News when asked to comment.
 

AstraZeneca takes a shot at transparency

The three primary objectives of the AstraZeneca AZD1222 trial outlined in the 110-page protocol include estimating the efficacy, safety, tolerability, and reactogenicity associated with two intramuscular doses of the vaccine in comparison with placebo in adults.

The projected enrollment is 30,000 participants, and the estimated primary completion date is Dec. 2, 2020, according to information on clinicaltrials.gov.

“Given the unprecedented global impact of the coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial,” the company said in a statement. “As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials.

“AstraZeneca continues to work with industry peers to ensure a consistent approach to sharing timely clinical trial information,” the company added.
 

Moderna methodology

The ModernaTX 135-page protocol outlines the primary trial objectives of evaluating efficacy, safety, and reactogenicity of two injections of the vaccine administered 28 days apart. Researchers also plan to randomly assign 30,000 adults to receive either vaccine or placebo. The estimated primary completion date is Oct. 27, 2022.

A statement that was requested from ModernaTX was not received by press time.
 

Pfizer protocol

In the Pfizer/BioNTech vaccine trial, researchers plan to evaluate different doses in different age groups in a multistep protocol. The trial features 20 primary safety objectives, which include reporting adverse events and serious adverse events, including any local or systemic events.

Efficacy endpoints are secondary objectives. The estimated enrollment is 29,481 adults; the estimated primary completion date is April 19, 2021.

“Pfizer and BioNTech recognize that the COVID-19 pandemic is a unique circumstance, and the need for transparency is clear,” Pfizer spokesperson Sharon Castillo told Medscape Medical News. By making the full protocol available, “we believe this will reinforce our long-standing commitment to scientific and regulatory rigor that benefits patients,” she said.

“Based on current infection rates, Pfizer and BioNTech continue to expect that a conclusive read-out on efficacy is likely by the end of October. Neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial,” Castillo said.

If clinical work and regulatory approval or authorization proceed as planned, Pfizer and BioNTech expect to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses worldwide by the end of 2021.

Pfizer is not willing to sacrifice safety and efficacy in the name of expediency, Castillo said. “We will not cut corners in this pursuit. Patient safety is our highest priority, and Pfizer will not bring a vaccine to market without adequate evidence of safety and efficacy.”
 

A positive move

“COVID-19 vaccines will only be useful if many people are willing to receive them,” said Kruse, a postgraduate year 3 resident in the Department of Pathology at Johns Hopkins Medicine in Baltimore, Maryland.

“By giving the general public along with other scientists and physicians the opportunity to critique the protocols, everyone can understand what the metrics would be for an early look at efficacy,” Kruse said. He noted that information could help inform a potential FDA emergency use authorization.

Kruse has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Hurricane Sally recently crossed the Gulf of Mexico and landed with torrential rainfalls along the Alabama coast. A little rainfall is important for crops; too much leads to devastation. As physicians, we need data in order to help manage patients’ illnesses and to help to keep them healthy. Our fear though is that too much data provided too quickly may have the opposite effect.

Personal monitoring devices

When I bought my first Fitbit 7 years ago, I was enamored with the technology. The Fitbit was little more than a step tracker, yet I proudly wore its black rubber strap on my wrist. It was my first foray into wearable technology, and it felt quite empowering to have an objective way to track my fitness beyond just using my bathroom scale. Now less than a decade later, that Fitbit looks archaic in comparison with the wrist-top technology currently available.

As I write this, the world’s largest technology company is in the process of releasing its sixth-generation Apple Watch. In addition to acting as a smartphone, this new device, which is barely larger than a postage stamp, offers GPS-based movement tracking, the ability to detect falls, continuous heart rate monitoring, a built-in EKG capable of diagnosing atrial fibrillation, and an oxygen saturation sensor. These features weren’t added thoughtlessly. Apple is marketing this as a health-focused device, with their primary advertising campaign claiming that “the future of health is on your wrist,” and they aren’t the only company making this play.

Along with Apple, Samsung, Withings, Fitbit, and other companies continue to bring products to market that monitor our activity and provide new insights into our health. Typically linked to smartphone-based apps, these devices record all of their measurements for later review, while software helps interpret the findings to make them actionable. From heart rate tracking to sleep analysis, these options now provide access to volumes of data that promise to improve our wellness and change our lives. Of course, those promises will only be fulfilled if our behavior is altered as a consequence of having more detailed information. Whether that will happen remains to be seen.
 

Health system–linked devices

Major advancements in medical monitoring technology are now enabling physicians to get much deeper insight into their patients’ health status. Internet-connected scales, blood pressure cuffs, and exercise equipment offer the ability to upload information into patient portals and integrate that information into EHRs. New devices provide access to information that previously was impossible to obtain. For example, wearable continuous blood glucose monitors, such as the FreeStyle Libre or DexCom’s G6, allow patients and physicians to follow blood sugar readings 24 hours a day. This provides unprecedented awareness of diabetes control and relieves the pain and inconvenience of finger sticks and blood draws. It also aids with compliance because patients don’t need to remember to check their sugar levels on a schedule.

Other compliance-boosting breakthroughs, such as Bluetooth-enabled asthma inhalers and cellular-connected continuous positive airway pressure machines, assist patients with managing chronic respiratory conditions. Many companies are developing technologies to manage acute conditions as well. One such company, an on-demand telemedicine provider called TytoCare, has developed a $299 suite of instruments that includes a digital stethoscope, thermometer, and camera-based otoscope. In concert with a virtual visit, their providers can remotely use these tools to examine and assess sick individuals. This virtual “laying on of hands” may have sounded like science fiction and likely would have been rejected by patients just a few years ago. Now it is becoming commonplace and will soon be an expectation of many seeking care.

We as clinicians need to learn how best to adapt to the new world and integrate these new sources of health data into our practices. But if we are to be successful, everyone must acknowledge that this revolution in health care brings many challenges along with it. One of those is the deluge of data that connected devices provide.
 

Information overload

There is such a thing as “too much of a good thing.” Described by journalist David Shenk as “data smog” in his 1997 book of the same name, the idea is clear: There is only so much information we can assimilate.

Even after years of using EHRs and with government-implemented incentives that promote “meaningful use,” physicians are still struggling with EHRs. Additionally, many have expressed frustration with the connectedness that EHRs provide and lament their inability to ever really “leave the office.” As more and more data become available to physicians, the challenge of how to assimilate and act on those data will continue to grow. The addition of patient-provided health statistics will only make information overload worse, with clinicians will feeling an ever-growing burden to know, understand, and act on this information.

Unless we develop systems to sort, filter, and prioritize the flow of information, there is potential for liability from not acting on the amount of virtual information doctors receive. This new risk for already fatigued and overburdened physicians combined with an increase in the amount of virtual information at doctors’ fingertips may lead to the value of patient data being lost.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Hurricane Sally recently crossed the Gulf of Mexico and landed with torrential rainfalls along the Alabama coast. A little rainfall is important for crops; too much leads to devastation. As physicians, we need data in order to help manage patients’ illnesses and to help to keep them healthy. Our fear though is that too much data provided too quickly may have the opposite effect.

Personal monitoring devices

When I bought my first Fitbit 7 years ago, I was enamored with the technology. The Fitbit was little more than a step tracker, yet I proudly wore its black rubber strap on my wrist. It was my first foray into wearable technology, and it felt quite empowering to have an objective way to track my fitness beyond just using my bathroom scale. Now less than a decade later, that Fitbit looks archaic in comparison with the wrist-top technology currently available.

As I write this, the world’s largest technology company is in the process of releasing its sixth-generation Apple Watch. In addition to acting as a smartphone, this new device, which is barely larger than a postage stamp, offers GPS-based movement tracking, the ability to detect falls, continuous heart rate monitoring, a built-in EKG capable of diagnosing atrial fibrillation, and an oxygen saturation sensor. These features weren’t added thoughtlessly. Apple is marketing this as a health-focused device, with their primary advertising campaign claiming that “the future of health is on your wrist,” and they aren’t the only company making this play.

Along with Apple, Samsung, Withings, Fitbit, and other companies continue to bring products to market that monitor our activity and provide new insights into our health. Typically linked to smartphone-based apps, these devices record all of their measurements for later review, while software helps interpret the findings to make them actionable. From heart rate tracking to sleep analysis, these options now provide access to volumes of data that promise to improve our wellness and change our lives. Of course, those promises will only be fulfilled if our behavior is altered as a consequence of having more detailed information. Whether that will happen remains to be seen.
 

Health system–linked devices

Major advancements in medical monitoring technology are now enabling physicians to get much deeper insight into their patients’ health status. Internet-connected scales, blood pressure cuffs, and exercise equipment offer the ability to upload information into patient portals and integrate that information into EHRs. New devices provide access to information that previously was impossible to obtain. For example, wearable continuous blood glucose monitors, such as the FreeStyle Libre or DexCom’s G6, allow patients and physicians to follow blood sugar readings 24 hours a day. This provides unprecedented awareness of diabetes control and relieves the pain and inconvenience of finger sticks and blood draws. It also aids with compliance because patients don’t need to remember to check their sugar levels on a schedule.

Other compliance-boosting breakthroughs, such as Bluetooth-enabled asthma inhalers and cellular-connected continuous positive airway pressure machines, assist patients with managing chronic respiratory conditions. Many companies are developing technologies to manage acute conditions as well. One such company, an on-demand telemedicine provider called TytoCare, has developed a $299 suite of instruments that includes a digital stethoscope, thermometer, and camera-based otoscope. In concert with a virtual visit, their providers can remotely use these tools to examine and assess sick individuals. This virtual “laying on of hands” may have sounded like science fiction and likely would have been rejected by patients just a few years ago. Now it is becoming commonplace and will soon be an expectation of many seeking care.

We as clinicians need to learn how best to adapt to the new world and integrate these new sources of health data into our practices. But if we are to be successful, everyone must acknowledge that this revolution in health care brings many challenges along with it. One of those is the deluge of data that connected devices provide.
 

Information overload

There is such a thing as “too much of a good thing.” Described by journalist David Shenk as “data smog” in his 1997 book of the same name, the idea is clear: There is only so much information we can assimilate.

Even after years of using EHRs and with government-implemented incentives that promote “meaningful use,” physicians are still struggling with EHRs. Additionally, many have expressed frustration with the connectedness that EHRs provide and lament their inability to ever really “leave the office.” As more and more data become available to physicians, the challenge of how to assimilate and act on those data will continue to grow. The addition of patient-provided health statistics will only make information overload worse, with clinicians will feeling an ever-growing burden to know, understand, and act on this information.

Unless we develop systems to sort, filter, and prioritize the flow of information, there is potential for liability from not acting on the amount of virtual information doctors receive. This new risk for already fatigued and overburdened physicians combined with an increase in the amount of virtual information at doctors’ fingertips may lead to the value of patient data being lost.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Hurricane Sally recently crossed the Gulf of Mexico and landed with torrential rainfalls along the Alabama coast. A little rainfall is important for crops; too much leads to devastation. As physicians, we need data in order to help manage patients’ illnesses and to help to keep them healthy. Our fear though is that too much data provided too quickly may have the opposite effect.

Personal monitoring devices

When I bought my first Fitbit 7 years ago, I was enamored with the technology. The Fitbit was little more than a step tracker, yet I proudly wore its black rubber strap on my wrist. It was my first foray into wearable technology, and it felt quite empowering to have an objective way to track my fitness beyond just using my bathroom scale. Now less than a decade later, that Fitbit looks archaic in comparison with the wrist-top technology currently available.

As I write this, the world’s largest technology company is in the process of releasing its sixth-generation Apple Watch. In addition to acting as a smartphone, this new device, which is barely larger than a postage stamp, offers GPS-based movement tracking, the ability to detect falls, continuous heart rate monitoring, a built-in EKG capable of diagnosing atrial fibrillation, and an oxygen saturation sensor. These features weren’t added thoughtlessly. Apple is marketing this as a health-focused device, with their primary advertising campaign claiming that “the future of health is on your wrist,” and they aren’t the only company making this play.

Along with Apple, Samsung, Withings, Fitbit, and other companies continue to bring products to market that monitor our activity and provide new insights into our health. Typically linked to smartphone-based apps, these devices record all of their measurements for later review, while software helps interpret the findings to make them actionable. From heart rate tracking to sleep analysis, these options now provide access to volumes of data that promise to improve our wellness and change our lives. Of course, those promises will only be fulfilled if our behavior is altered as a consequence of having more detailed information. Whether that will happen remains to be seen.
 

Health system–linked devices

Major advancements in medical monitoring technology are now enabling physicians to get much deeper insight into their patients’ health status. Internet-connected scales, blood pressure cuffs, and exercise equipment offer the ability to upload information into patient portals and integrate that information into EHRs. New devices provide access to information that previously was impossible to obtain. For example, wearable continuous blood glucose monitors, such as the FreeStyle Libre or DexCom’s G6, allow patients and physicians to follow blood sugar readings 24 hours a day. This provides unprecedented awareness of diabetes control and relieves the pain and inconvenience of finger sticks and blood draws. It also aids with compliance because patients don’t need to remember to check their sugar levels on a schedule.

Other compliance-boosting breakthroughs, such as Bluetooth-enabled asthma inhalers and cellular-connected continuous positive airway pressure machines, assist patients with managing chronic respiratory conditions. Many companies are developing technologies to manage acute conditions as well. One such company, an on-demand telemedicine provider called TytoCare, has developed a $299 suite of instruments that includes a digital stethoscope, thermometer, and camera-based otoscope. In concert with a virtual visit, their providers can remotely use these tools to examine and assess sick individuals. This virtual “laying on of hands” may have sounded like science fiction and likely would have been rejected by patients just a few years ago. Now it is becoming commonplace and will soon be an expectation of many seeking care.

We as clinicians need to learn how best to adapt to the new world and integrate these new sources of health data into our practices. But if we are to be successful, everyone must acknowledge that this revolution in health care brings many challenges along with it. One of those is the deluge of data that connected devices provide.
 

Information overload

There is such a thing as “too much of a good thing.” Described by journalist David Shenk as “data smog” in his 1997 book of the same name, the idea is clear: There is only so much information we can assimilate.

Even after years of using EHRs and with government-implemented incentives that promote “meaningful use,” physicians are still struggling with EHRs. Additionally, many have expressed frustration with the connectedness that EHRs provide and lament their inability to ever really “leave the office.” As more and more data become available to physicians, the challenge of how to assimilate and act on those data will continue to grow. The addition of patient-provided health statistics will only make information overload worse, with clinicians will feeling an ever-growing burden to know, understand, and act on this information.

Unless we develop systems to sort, filter, and prioritize the flow of information, there is potential for liability from not acting on the amount of virtual information doctors receive. This new risk for already fatigued and overburdened physicians combined with an increase in the amount of virtual information at doctors’ fingertips may lead to the value of patient data being lost.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.