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Click for Credit: Endometriosis surgery benefits; diabetes & aging; more
Here are 5 articles from the March issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):
1. Endometriosis surgery: Women can expect years-long benefits
To take the posttest, go to: https://bit.ly/2Ez8mdu
Expires January 3, 2019
2. Cerebral small vessel disease progression linked to MCI in hypertensive patients
To take the posttest, go to: https://bit.ly/2ExDV7o
Expires January 4, 2019
3. Adult atopic dermatitis is fraught with dermatologic comorbidities
To take the posttest, go to: https://bit.ly/2Vl7E9a
Expires January 11, 2019
4. Antidepressants tied to greater hip fracture incidence in older adults
To take the posttest, go to: https://bit.ly/2GRfMeH
Expires January 4, 2019
5. Researchers exploring ways to mitigate aging’s impact on diabetes
To take the posttest, go to: https://bit.ly/2tFxF7v
Expires January 8, 2019
Here are 5 articles from the March issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):
1. Endometriosis surgery: Women can expect years-long benefits
To take the posttest, go to: https://bit.ly/2Ez8mdu
Expires January 3, 2019
2. Cerebral small vessel disease progression linked to MCI in hypertensive patients
To take the posttest, go to: https://bit.ly/2ExDV7o
Expires January 4, 2019
3. Adult atopic dermatitis is fraught with dermatologic comorbidities
To take the posttest, go to: https://bit.ly/2Vl7E9a
Expires January 11, 2019
4. Antidepressants tied to greater hip fracture incidence in older adults
To take the posttest, go to: https://bit.ly/2GRfMeH
Expires January 4, 2019
5. Researchers exploring ways to mitigate aging’s impact on diabetes
To take the posttest, go to: https://bit.ly/2tFxF7v
Expires January 8, 2019
Here are 5 articles from the March issue of Clinician Reviews (individual articles are valid for one year from date of publication—expiration dates below):
1. Endometriosis surgery: Women can expect years-long benefits
To take the posttest, go to: https://bit.ly/2Ez8mdu
Expires January 3, 2019
2. Cerebral small vessel disease progression linked to MCI in hypertensive patients
To take the posttest, go to: https://bit.ly/2ExDV7o
Expires January 4, 2019
3. Adult atopic dermatitis is fraught with dermatologic comorbidities
To take the posttest, go to: https://bit.ly/2Vl7E9a
Expires January 11, 2019
4. Antidepressants tied to greater hip fracture incidence in older adults
To take the posttest, go to: https://bit.ly/2GRfMeH
Expires January 4, 2019
5. Researchers exploring ways to mitigate aging’s impact on diabetes
To take the posttest, go to: https://bit.ly/2tFxF7v
Expires January 8, 2019
Pediatric pruritus requires distinct approach to assessment and management
WASHINGTON – Suephy C. Chen, MD, said at the annual meeting of the American Academy of Dermatology.
Using special scales to measure itch in children and understanding that quality of life concerns may be different for children should also be kept in mind, said Dr. Chen, professor of dermatology at Emory University, Atlanta. Furthermore, several psychiatric comorbidities that have been associated with pediatric pruritus, such as ADHD and suicidal thoughts. Another consideration is that a child’s pruritus can have significant effects on his or her parents.
Measuring itch is challenging in children, who may have difficulty responding to visual analogue scales, verbal rating scales, and numerical rating scales. Dr. Chen and her colleagues developed the ItchyQuant scale as a self-report measure of itch severity (J Invest Dermatol. 2017 Jan;137[1]:57-61). It is a scale from 0 to 10 with cartoon illustrations depicting increasing itch severity, from no itch to the “worst itch imaginable.” Currently it is validated only in adults, but they are working towards getting it validated in children.
Another itch assessment scale for children, Itch Man, is available, but has only been studied in children who have survived burns.
The ItchyQOL scale measures the extent to which itch affects quality of life in adults. It examines the symptoms associated with itch, as well as its functional and emotional effects. But children’s concerns about quality of life are not the same as those of adults, so Dr. Chen and her colleagues used ItchyQOL as a basis for the “Tween ItchyQOL,” which is intended for children aged 8-17 years, and the “Kids ItchyQOL,” which is intended for children aged 6-7 years. The Tween ItchyQOL includes items (such as being made fun of) that are not in the ItchyQOL and eliminates items (such as working and spending money) that do not apply to children. The Kids ItchyQOL includes cartoons to help children understand the questions.
Dermatologists often use parents as proxies to measure their children’s itch, assuming that the latter’s responses might be unreliable. But when Dr. Chen and her colleagues administered the ItchyQuant to children with pruritus, parents, and their medical providers to evaluate the extent of agreement among assessors, they found that parents’ scores were higher than their children’s scores, although the difference was not significant.
Providers’ scores, however, were significantly lower than those of children and parents. All scores were in the moderate range. Dr. Chen and colleagues also found that, for each 1-point increase in the difference between children’s and parents’ responses, parents were 1.25 times less likely to have experience with chronic pruritus, outside of their children. This finding provides a gauge of how well a parent can serve as a proxy to characterize his or her child’s itch.
Adolescents are in general a troubled group, and caregivers have concerns about suicide in the adolescent population, Dr. Chen said. She referred to a large study of adolescents published in 2012, which indicated that the prevalence of suicidal ideation was 8.4% among adolescents with no itch, compared with 21.1% among adolescents with severe itch (Acta Derm Venereol. 2012 Sep;92[5]:543-6).
In the study, those with severe itch were three times more likely to have suicidal ideation than the general population, which Dr. Chen noted was comparable with that of suicidal ideation in patients with chronic pain in the study (odds ratio, 3.8).
Cross-sectional data suggest a link between itching and ADHD, but “it’s a chicken-and-egg phenomenon,” she said. “If you’re so itchy and squirmy, you’re not going to pay attention. Then again, if you’re not paying attention, maybe you’re that much more prone to scratch.” Longitudinal data indicate that improving itch correlates with improvement in ADHD symptoms.
In addition, pruritus affects the genders disproportionately. Girls report a significantly greater impact on quality of life than boys when itching is severe, with much of the difference in emotional impact, said Dr. Chen. Boys may report more functional impact than girls.
Chronic pruritus also affects parents, who may have disturbed sleep, feel stress about their own parenting, and have difficulty enforcing discipline. “They feel an incredible amount of guilt and blame for giving this to their child,” she commented. “As more and more places develop itch centers, it would be good to have a multidisciplinary approach bringing in mental health providers and social workers, because the impact of itch on parents can be quite profound.”
Dr. Chen reported disclosures with several companies, including BioPharmX, Dermecular Therapeutics, Leo Pharma, and Unilever.
WASHINGTON – Suephy C. Chen, MD, said at the annual meeting of the American Academy of Dermatology.
Using special scales to measure itch in children and understanding that quality of life concerns may be different for children should also be kept in mind, said Dr. Chen, professor of dermatology at Emory University, Atlanta. Furthermore, several psychiatric comorbidities that have been associated with pediatric pruritus, such as ADHD and suicidal thoughts. Another consideration is that a child’s pruritus can have significant effects on his or her parents.
Measuring itch is challenging in children, who may have difficulty responding to visual analogue scales, verbal rating scales, and numerical rating scales. Dr. Chen and her colleagues developed the ItchyQuant scale as a self-report measure of itch severity (J Invest Dermatol. 2017 Jan;137[1]:57-61). It is a scale from 0 to 10 with cartoon illustrations depicting increasing itch severity, from no itch to the “worst itch imaginable.” Currently it is validated only in adults, but they are working towards getting it validated in children.
Another itch assessment scale for children, Itch Man, is available, but has only been studied in children who have survived burns.
The ItchyQOL scale measures the extent to which itch affects quality of life in adults. It examines the symptoms associated with itch, as well as its functional and emotional effects. But children’s concerns about quality of life are not the same as those of adults, so Dr. Chen and her colleagues used ItchyQOL as a basis for the “Tween ItchyQOL,” which is intended for children aged 8-17 years, and the “Kids ItchyQOL,” which is intended for children aged 6-7 years. The Tween ItchyQOL includes items (such as being made fun of) that are not in the ItchyQOL and eliminates items (such as working and spending money) that do not apply to children. The Kids ItchyQOL includes cartoons to help children understand the questions.
Dermatologists often use parents as proxies to measure their children’s itch, assuming that the latter’s responses might be unreliable. But when Dr. Chen and her colleagues administered the ItchyQuant to children with pruritus, parents, and their medical providers to evaluate the extent of agreement among assessors, they found that parents’ scores were higher than their children’s scores, although the difference was not significant.
Providers’ scores, however, were significantly lower than those of children and parents. All scores were in the moderate range. Dr. Chen and colleagues also found that, for each 1-point increase in the difference between children’s and parents’ responses, parents were 1.25 times less likely to have experience with chronic pruritus, outside of their children. This finding provides a gauge of how well a parent can serve as a proxy to characterize his or her child’s itch.
Adolescents are in general a troubled group, and caregivers have concerns about suicide in the adolescent population, Dr. Chen said. She referred to a large study of adolescents published in 2012, which indicated that the prevalence of suicidal ideation was 8.4% among adolescents with no itch, compared with 21.1% among adolescents with severe itch (Acta Derm Venereol. 2012 Sep;92[5]:543-6).
In the study, those with severe itch were three times more likely to have suicidal ideation than the general population, which Dr. Chen noted was comparable with that of suicidal ideation in patients with chronic pain in the study (odds ratio, 3.8).
Cross-sectional data suggest a link between itching and ADHD, but “it’s a chicken-and-egg phenomenon,” she said. “If you’re so itchy and squirmy, you’re not going to pay attention. Then again, if you’re not paying attention, maybe you’re that much more prone to scratch.” Longitudinal data indicate that improving itch correlates with improvement in ADHD symptoms.
In addition, pruritus affects the genders disproportionately. Girls report a significantly greater impact on quality of life than boys when itching is severe, with much of the difference in emotional impact, said Dr. Chen. Boys may report more functional impact than girls.
Chronic pruritus also affects parents, who may have disturbed sleep, feel stress about their own parenting, and have difficulty enforcing discipline. “They feel an incredible amount of guilt and blame for giving this to their child,” she commented. “As more and more places develop itch centers, it would be good to have a multidisciplinary approach bringing in mental health providers and social workers, because the impact of itch on parents can be quite profound.”
Dr. Chen reported disclosures with several companies, including BioPharmX, Dermecular Therapeutics, Leo Pharma, and Unilever.
WASHINGTON – Suephy C. Chen, MD, said at the annual meeting of the American Academy of Dermatology.
Using special scales to measure itch in children and understanding that quality of life concerns may be different for children should also be kept in mind, said Dr. Chen, professor of dermatology at Emory University, Atlanta. Furthermore, several psychiatric comorbidities that have been associated with pediatric pruritus, such as ADHD and suicidal thoughts. Another consideration is that a child’s pruritus can have significant effects on his or her parents.
Measuring itch is challenging in children, who may have difficulty responding to visual analogue scales, verbal rating scales, and numerical rating scales. Dr. Chen and her colleagues developed the ItchyQuant scale as a self-report measure of itch severity (J Invest Dermatol. 2017 Jan;137[1]:57-61). It is a scale from 0 to 10 with cartoon illustrations depicting increasing itch severity, from no itch to the “worst itch imaginable.” Currently it is validated only in adults, but they are working towards getting it validated in children.
Another itch assessment scale for children, Itch Man, is available, but has only been studied in children who have survived burns.
The ItchyQOL scale measures the extent to which itch affects quality of life in adults. It examines the symptoms associated with itch, as well as its functional and emotional effects. But children’s concerns about quality of life are not the same as those of adults, so Dr. Chen and her colleagues used ItchyQOL as a basis for the “Tween ItchyQOL,” which is intended for children aged 8-17 years, and the “Kids ItchyQOL,” which is intended for children aged 6-7 years. The Tween ItchyQOL includes items (such as being made fun of) that are not in the ItchyQOL and eliminates items (such as working and spending money) that do not apply to children. The Kids ItchyQOL includes cartoons to help children understand the questions.
Dermatologists often use parents as proxies to measure their children’s itch, assuming that the latter’s responses might be unreliable. But when Dr. Chen and her colleagues administered the ItchyQuant to children with pruritus, parents, and their medical providers to evaluate the extent of agreement among assessors, they found that parents’ scores were higher than their children’s scores, although the difference was not significant.
Providers’ scores, however, were significantly lower than those of children and parents. All scores were in the moderate range. Dr. Chen and colleagues also found that, for each 1-point increase in the difference between children’s and parents’ responses, parents were 1.25 times less likely to have experience with chronic pruritus, outside of their children. This finding provides a gauge of how well a parent can serve as a proxy to characterize his or her child’s itch.
Adolescents are in general a troubled group, and caregivers have concerns about suicide in the adolescent population, Dr. Chen said. She referred to a large study of adolescents published in 2012, which indicated that the prevalence of suicidal ideation was 8.4% among adolescents with no itch, compared with 21.1% among adolescents with severe itch (Acta Derm Venereol. 2012 Sep;92[5]:543-6).
In the study, those with severe itch were three times more likely to have suicidal ideation than the general population, which Dr. Chen noted was comparable with that of suicidal ideation in patients with chronic pain in the study (odds ratio, 3.8).
Cross-sectional data suggest a link between itching and ADHD, but “it’s a chicken-and-egg phenomenon,” she said. “If you’re so itchy and squirmy, you’re not going to pay attention. Then again, if you’re not paying attention, maybe you’re that much more prone to scratch.” Longitudinal data indicate that improving itch correlates with improvement in ADHD symptoms.
In addition, pruritus affects the genders disproportionately. Girls report a significantly greater impact on quality of life than boys when itching is severe, with much of the difference in emotional impact, said Dr. Chen. Boys may report more functional impact than girls.
Chronic pruritus also affects parents, who may have disturbed sleep, feel stress about their own parenting, and have difficulty enforcing discipline. “They feel an incredible amount of guilt and blame for giving this to their child,” she commented. “As more and more places develop itch centers, it would be good to have a multidisciplinary approach bringing in mental health providers and social workers, because the impact of itch on parents can be quite profound.”
Dr. Chen reported disclosures with several companies, including BioPharmX, Dermecular Therapeutics, Leo Pharma, and Unilever.
REPORTING FROM AAD 2019
Bermekimab reduces lesions, cuts pain in patients with hidradenitis suppurativa
WASHINGTON – It was nearly as effective in patients refractory to anti–tumor necrosis factor (TNF) therapy as it was to those naive to the treatment.
The antibody, which is derived directly from healthy human volunteers and then lab expanded, also improved patients’ quality of life in a “clinically meaningful way,” Alice Gottlieb, MD, PhD said at the annual meeting of the American Academy of Dermatology.
“These are sick people, and improvement of this kind is really something very important,” said Dr. Gottlieb of Mount Sinai Medical Center in New York. “I think what we see here supports the movement of bermekimab into phase 3 studies for HS [hidradenitis suppurativa].”
Bermekimab is the first inhibitor of IL-1 alpha to be investigated in HS. An overabundance of the cytokine produces several potentially problematic effects. IL-1 alpha induces inflammatory cells to migrate into the skin, drives neoangiogenesis, potentiates pain, and induces matrix metalloproteinase. The last two are particularly an issue in patients with HS. The abscesses and fistulas cause severe pain, which Dr. Gottlieb said is an undertreated and an underappreciated driver of disease disability. The tissue breakdown characteristic of the disease can also be highly disfiguring. “Many patients, especially my female patients, look as if they are basically autodigesting.”
IL-1 alpha also induces procollagen type I and III and fibroblast proliferation, contributing to the scarring many patients experience.
“Ten years ago, I thought it would be a potential target for HS,” Dr, Gottlieb said, and the idea has finally come to fruition through studies by biopharmaceutical company XBiotech in Austin, Tex. Dr. Gottlieb designed the treatment protocol and was a principal investigator on the study.
A similarly positive 2018 study employed twice-weekly intravenous infusions; this study utilized a more-concentrated form of the antibody delivered subcutaneously from prefilled syringes.
The study comprised 42 patients, 24 of whom had failed a course of anti-TNF therapy and 18 of whom were anti-TNF naive. Each group received bermekimab 400 mg subcutaneous once a week for 12 weeks. The primary endpoint was change on the Hidradenitis Suppurativa Clinical Response Score; good response was deemed at least a 50% reduction in abscesses and inflammatory nodules, with no new abscesses or draining fistulas. Secondary endpoints included pain scores, patient quality of life, and the physicians global clinical assessment.
At baseline, subjects in the anti-TNF–refractory group had a worse clinical profile than the naive patients, with more abscesses and inflammatory nodules (mean, 14 vs. 6) and worse scores on the Physicians Global Assessment. But they reported similar pain on a 10-point scale (around 8) and negative quality of life (17/30). Both groups experienced anxiety and depression.
Eight patients dropped out before finishing the trial for a variety of reasons, including family and transportation issues and comorbid illness. Only one discontinued for a reaction to the study drug (injection site redness). These patients were included in the final analysis in a last observation carried forward.
About 10% of patients began to experience improvement as soon as 2 weeks after the first injection. By week 6, 40% of the refractory patients and 10% of the naive patents had experienced a lesion reduction of at least 50%. By the end of the study, however, about 62% of patients in each group achieved that goal.
By week 12, the mean improvement in the Physicians Global Assessment was about 23% in the refractory group and 53% in the naive group. Both results were significant improvements over baseline.
The mean improvement in the pain score was about 54% in the refractory group and 65% in the naive group. In a scale that measured patients’ view of their disease severity, refractory patients reported a mean 40% improvement, and naive patients, a mean 67% improvement.
There were 57 adverse events recorded; 94% were grade 1 or 2. There were two serious adverse events requiring hospitalization – a fall and an admission for HS pain. Neither were judged related to the study drug. Two patients experienced injection site reactions and one patient experienced six bouts of nausea. There were no serious infections, no major cardiovascular events, and no neoplasms.
Dr. Gottlieb designed the study protocol and was a principal investigator. She did not receive financial compensation from the company.
WASHINGTON – It was nearly as effective in patients refractory to anti–tumor necrosis factor (TNF) therapy as it was to those naive to the treatment.
The antibody, which is derived directly from healthy human volunteers and then lab expanded, also improved patients’ quality of life in a “clinically meaningful way,” Alice Gottlieb, MD, PhD said at the annual meeting of the American Academy of Dermatology.
“These are sick people, and improvement of this kind is really something very important,” said Dr. Gottlieb of Mount Sinai Medical Center in New York. “I think what we see here supports the movement of bermekimab into phase 3 studies for HS [hidradenitis suppurativa].”
Bermekimab is the first inhibitor of IL-1 alpha to be investigated in HS. An overabundance of the cytokine produces several potentially problematic effects. IL-1 alpha induces inflammatory cells to migrate into the skin, drives neoangiogenesis, potentiates pain, and induces matrix metalloproteinase. The last two are particularly an issue in patients with HS. The abscesses and fistulas cause severe pain, which Dr. Gottlieb said is an undertreated and an underappreciated driver of disease disability. The tissue breakdown characteristic of the disease can also be highly disfiguring. “Many patients, especially my female patients, look as if they are basically autodigesting.”
IL-1 alpha also induces procollagen type I and III and fibroblast proliferation, contributing to the scarring many patients experience.
“Ten years ago, I thought it would be a potential target for HS,” Dr, Gottlieb said, and the idea has finally come to fruition through studies by biopharmaceutical company XBiotech in Austin, Tex. Dr. Gottlieb designed the treatment protocol and was a principal investigator on the study.
A similarly positive 2018 study employed twice-weekly intravenous infusions; this study utilized a more-concentrated form of the antibody delivered subcutaneously from prefilled syringes.
The study comprised 42 patients, 24 of whom had failed a course of anti-TNF therapy and 18 of whom were anti-TNF naive. Each group received bermekimab 400 mg subcutaneous once a week for 12 weeks. The primary endpoint was change on the Hidradenitis Suppurativa Clinical Response Score; good response was deemed at least a 50% reduction in abscesses and inflammatory nodules, with no new abscesses or draining fistulas. Secondary endpoints included pain scores, patient quality of life, and the physicians global clinical assessment.
At baseline, subjects in the anti-TNF–refractory group had a worse clinical profile than the naive patients, with more abscesses and inflammatory nodules (mean, 14 vs. 6) and worse scores on the Physicians Global Assessment. But they reported similar pain on a 10-point scale (around 8) and negative quality of life (17/30). Both groups experienced anxiety and depression.
Eight patients dropped out before finishing the trial for a variety of reasons, including family and transportation issues and comorbid illness. Only one discontinued for a reaction to the study drug (injection site redness). These patients were included in the final analysis in a last observation carried forward.
About 10% of patients began to experience improvement as soon as 2 weeks after the first injection. By week 6, 40% of the refractory patients and 10% of the naive patents had experienced a lesion reduction of at least 50%. By the end of the study, however, about 62% of patients in each group achieved that goal.
By week 12, the mean improvement in the Physicians Global Assessment was about 23% in the refractory group and 53% in the naive group. Both results were significant improvements over baseline.
The mean improvement in the pain score was about 54% in the refractory group and 65% in the naive group. In a scale that measured patients’ view of their disease severity, refractory patients reported a mean 40% improvement, and naive patients, a mean 67% improvement.
There were 57 adverse events recorded; 94% were grade 1 or 2. There were two serious adverse events requiring hospitalization – a fall and an admission for HS pain. Neither were judged related to the study drug. Two patients experienced injection site reactions and one patient experienced six bouts of nausea. There were no serious infections, no major cardiovascular events, and no neoplasms.
Dr. Gottlieb designed the study protocol and was a principal investigator. She did not receive financial compensation from the company.
WASHINGTON – It was nearly as effective in patients refractory to anti–tumor necrosis factor (TNF) therapy as it was to those naive to the treatment.
The antibody, which is derived directly from healthy human volunteers and then lab expanded, also improved patients’ quality of life in a “clinically meaningful way,” Alice Gottlieb, MD, PhD said at the annual meeting of the American Academy of Dermatology.
“These are sick people, and improvement of this kind is really something very important,” said Dr. Gottlieb of Mount Sinai Medical Center in New York. “I think what we see here supports the movement of bermekimab into phase 3 studies for HS [hidradenitis suppurativa].”
Bermekimab is the first inhibitor of IL-1 alpha to be investigated in HS. An overabundance of the cytokine produces several potentially problematic effects. IL-1 alpha induces inflammatory cells to migrate into the skin, drives neoangiogenesis, potentiates pain, and induces matrix metalloproteinase. The last two are particularly an issue in patients with HS. The abscesses and fistulas cause severe pain, which Dr. Gottlieb said is an undertreated and an underappreciated driver of disease disability. The tissue breakdown characteristic of the disease can also be highly disfiguring. “Many patients, especially my female patients, look as if they are basically autodigesting.”
IL-1 alpha also induces procollagen type I and III and fibroblast proliferation, contributing to the scarring many patients experience.
“Ten years ago, I thought it would be a potential target for HS,” Dr, Gottlieb said, and the idea has finally come to fruition through studies by biopharmaceutical company XBiotech in Austin, Tex. Dr. Gottlieb designed the treatment protocol and was a principal investigator on the study.
A similarly positive 2018 study employed twice-weekly intravenous infusions; this study utilized a more-concentrated form of the antibody delivered subcutaneously from prefilled syringes.
The study comprised 42 patients, 24 of whom had failed a course of anti-TNF therapy and 18 of whom were anti-TNF naive. Each group received bermekimab 400 mg subcutaneous once a week for 12 weeks. The primary endpoint was change on the Hidradenitis Suppurativa Clinical Response Score; good response was deemed at least a 50% reduction in abscesses and inflammatory nodules, with no new abscesses or draining fistulas. Secondary endpoints included pain scores, patient quality of life, and the physicians global clinical assessment.
At baseline, subjects in the anti-TNF–refractory group had a worse clinical profile than the naive patients, with more abscesses and inflammatory nodules (mean, 14 vs. 6) and worse scores on the Physicians Global Assessment. But they reported similar pain on a 10-point scale (around 8) and negative quality of life (17/30). Both groups experienced anxiety and depression.
Eight patients dropped out before finishing the trial for a variety of reasons, including family and transportation issues and comorbid illness. Only one discontinued for a reaction to the study drug (injection site redness). These patients were included in the final analysis in a last observation carried forward.
About 10% of patients began to experience improvement as soon as 2 weeks after the first injection. By week 6, 40% of the refractory patients and 10% of the naive patents had experienced a lesion reduction of at least 50%. By the end of the study, however, about 62% of patients in each group achieved that goal.
By week 12, the mean improvement in the Physicians Global Assessment was about 23% in the refractory group and 53% in the naive group. Both results were significant improvements over baseline.
The mean improvement in the pain score was about 54% in the refractory group and 65% in the naive group. In a scale that measured patients’ view of their disease severity, refractory patients reported a mean 40% improvement, and naive patients, a mean 67% improvement.
There were 57 adverse events recorded; 94% were grade 1 or 2. There were two serious adverse events requiring hospitalization – a fall and an admission for HS pain. Neither were judged related to the study drug. Two patients experienced injection site reactions and one patient experienced six bouts of nausea. There were no serious infections, no major cardiovascular events, and no neoplasms.
Dr. Gottlieb designed the study protocol and was a principal investigator. She did not receive financial compensation from the company.
REPORTING FROM AAD 2019
Eczema increases the risk of impaired mental health among children
WASHINGTON – according to an analysis described at the annual meeting of the American Academy of Dermatology. Eczema appears to influence several domains of mental health, and the association remains in the absence of other atopic illnesses.
Estimates of the prevalence of eczema in children have ranged as high as 20%. European and Japanese studies have suggested that children with eczema have greater mental health impairments overall, but researchers have not evaluated this association among U.S. children. Although it has been established that children with eczema consult health care providers more often than children without eczema, data on health care utilization among children with eczema and impaired mental health are limited.
Joy Wan, MD, a dermatologist at Children’s Hospital of Philadelphia, and her colleagues performed a cross-sectional analysis of data obtained from 2013 to 2017 by the National Health Interview Survey. The Centers for Disease Control and Prevention administers the survey to a representative sample of the U.S. population. Children in each household are randomly sampled, and adult caregivers provide detailed health information about them.
Dr. Wan and her colleagues included children aged between 4 and 17 years in their analysis. The exposure of interest was eczema. Caregivers reported eczema in response to the question, “During the past 12 months, has the child had eczema or any kind of skin allergy?” The study’s primary outcome was mental health impairment. Using the Strengths and Difficulties Questionnaire (SDQ), the investigators categorized mental health impairment as none, mild, or severe. The SDQ is a validated instrument that assesses symptoms of mental health in children in domains such as conduct, emotion, peer relationships, and attention, which the researchers chose as secondary outcomes of interest. Dr. Wan’s group also examined the utilization of mental health and other health and social services among children with eczema.
The researchers performed logistic regression analysis to obtain odds ratios for mental health impairment among children with eczema, adjusting the analysis for potential socioeconomic and demographic confounders. Furthermore, they stratified the primary model by other atopic and behavioral disorders to assess for potential effects modification by these concomitant illnesses.
Approximately 12% of the children in the sample had eczema. Children with eczema tended to be female, non-Hispanic, or black; they also were more likely to report good, fair, or poor health, compared with children without eczema. Asthma, allergic rhinitis, and ADHD were more common among children with eczema than those without.
About 27% of children with eczema had any mental health impairment, compared with approximately 18% of children without eczema. About 11% of children with eczema had severe impairment; this rate was almost twice as high as that in children without eczema, Dr. Wan said. The adjusted odds of mental health impairment were 52% per year among children with eczema, compared with those without.
When the researchers examined specific domains of mental health, they found that children with eczema were significantly less likely to be reported to be well behaved or to have good attention spans. They also were significantly more likely to worry often, be unhappy or depressed, and to get along better with adults than their peers.
When Dr. Wan and his colleagues stratified the primary model by other atopic illnesses, they found that, among children without any other atopic illness, eczema remained independently associated with mental health impairment (OR, 1.52). The effect remained similar among children with asthma alone, but was attenuated among children with allergic rhinitis alone or with asthma and allergic rhinitis.
In the absence of ADHD, the investigators found a statistically significant effect of eczema on mental health impairment (OR, 1.46). In the presence of ADHD, the effect remained significant, but was attenuated.
Finally, approximately 20% of children with mildly impaired mental health had seen a mental health professional in the past year. In addition, 54% of children with severe mental health symptoms had seen a mental health professional in the past year. Among children with severe impairment, about 80% had consulted a general practitioner in the past year; 45% of them reported emotional or behavioral issues as the reason for the visit. Use of special education and early intervention services were more prevalent among children with increasing degrees of mental health impairment.
The study’s strengths include its population-based design, the use of a validated psychometric instrument, and the adjustment of data for socioeconomic factors and other comorbid illnesses, Dr. Wan said. The study is cross sectional, however, which precludes conclusions about the directionality of the relationship between eczema and mental health. In addition, the SDQ may not capture all mental health symptoms that eczema affects.
It is imperative that clinicians and caregivers recognize how common mental health impairment is among children with eczema so that children can be appropriately screened and referred for care, Dr. Wan said. “Our study suggests that there may be a critical gap in mental health services utilization by children who have eczema and concomitant mental health impairment. Some of the future directions in this area may be to understand the potential barriers to mental health care in children with eczema, and certainly to identify potentially effective interventions to reduce the mental health burden in pediatric eczema.”
Dr. Wan reported receiving research fellowship funding from Pfizer.
WASHINGTON – according to an analysis described at the annual meeting of the American Academy of Dermatology. Eczema appears to influence several domains of mental health, and the association remains in the absence of other atopic illnesses.
Estimates of the prevalence of eczema in children have ranged as high as 20%. European and Japanese studies have suggested that children with eczema have greater mental health impairments overall, but researchers have not evaluated this association among U.S. children. Although it has been established that children with eczema consult health care providers more often than children without eczema, data on health care utilization among children with eczema and impaired mental health are limited.
Joy Wan, MD, a dermatologist at Children’s Hospital of Philadelphia, and her colleagues performed a cross-sectional analysis of data obtained from 2013 to 2017 by the National Health Interview Survey. The Centers for Disease Control and Prevention administers the survey to a representative sample of the U.S. population. Children in each household are randomly sampled, and adult caregivers provide detailed health information about them.
Dr. Wan and her colleagues included children aged between 4 and 17 years in their analysis. The exposure of interest was eczema. Caregivers reported eczema in response to the question, “During the past 12 months, has the child had eczema or any kind of skin allergy?” The study’s primary outcome was mental health impairment. Using the Strengths and Difficulties Questionnaire (SDQ), the investigators categorized mental health impairment as none, mild, or severe. The SDQ is a validated instrument that assesses symptoms of mental health in children in domains such as conduct, emotion, peer relationships, and attention, which the researchers chose as secondary outcomes of interest. Dr. Wan’s group also examined the utilization of mental health and other health and social services among children with eczema.
The researchers performed logistic regression analysis to obtain odds ratios for mental health impairment among children with eczema, adjusting the analysis for potential socioeconomic and demographic confounders. Furthermore, they stratified the primary model by other atopic and behavioral disorders to assess for potential effects modification by these concomitant illnesses.
Approximately 12% of the children in the sample had eczema. Children with eczema tended to be female, non-Hispanic, or black; they also were more likely to report good, fair, or poor health, compared with children without eczema. Asthma, allergic rhinitis, and ADHD were more common among children with eczema than those without.
About 27% of children with eczema had any mental health impairment, compared with approximately 18% of children without eczema. About 11% of children with eczema had severe impairment; this rate was almost twice as high as that in children without eczema, Dr. Wan said. The adjusted odds of mental health impairment were 52% per year among children with eczema, compared with those without.
When the researchers examined specific domains of mental health, they found that children with eczema were significantly less likely to be reported to be well behaved or to have good attention spans. They also were significantly more likely to worry often, be unhappy or depressed, and to get along better with adults than their peers.
When Dr. Wan and his colleagues stratified the primary model by other atopic illnesses, they found that, among children without any other atopic illness, eczema remained independently associated with mental health impairment (OR, 1.52). The effect remained similar among children with asthma alone, but was attenuated among children with allergic rhinitis alone or with asthma and allergic rhinitis.
In the absence of ADHD, the investigators found a statistically significant effect of eczema on mental health impairment (OR, 1.46). In the presence of ADHD, the effect remained significant, but was attenuated.
Finally, approximately 20% of children with mildly impaired mental health had seen a mental health professional in the past year. In addition, 54% of children with severe mental health symptoms had seen a mental health professional in the past year. Among children with severe impairment, about 80% had consulted a general practitioner in the past year; 45% of them reported emotional or behavioral issues as the reason for the visit. Use of special education and early intervention services were more prevalent among children with increasing degrees of mental health impairment.
The study’s strengths include its population-based design, the use of a validated psychometric instrument, and the adjustment of data for socioeconomic factors and other comorbid illnesses, Dr. Wan said. The study is cross sectional, however, which precludes conclusions about the directionality of the relationship between eczema and mental health. In addition, the SDQ may not capture all mental health symptoms that eczema affects.
It is imperative that clinicians and caregivers recognize how common mental health impairment is among children with eczema so that children can be appropriately screened and referred for care, Dr. Wan said. “Our study suggests that there may be a critical gap in mental health services utilization by children who have eczema and concomitant mental health impairment. Some of the future directions in this area may be to understand the potential barriers to mental health care in children with eczema, and certainly to identify potentially effective interventions to reduce the mental health burden in pediatric eczema.”
Dr. Wan reported receiving research fellowship funding from Pfizer.
WASHINGTON – according to an analysis described at the annual meeting of the American Academy of Dermatology. Eczema appears to influence several domains of mental health, and the association remains in the absence of other atopic illnesses.
Estimates of the prevalence of eczema in children have ranged as high as 20%. European and Japanese studies have suggested that children with eczema have greater mental health impairments overall, but researchers have not evaluated this association among U.S. children. Although it has been established that children with eczema consult health care providers more often than children without eczema, data on health care utilization among children with eczema and impaired mental health are limited.
Joy Wan, MD, a dermatologist at Children’s Hospital of Philadelphia, and her colleagues performed a cross-sectional analysis of data obtained from 2013 to 2017 by the National Health Interview Survey. The Centers for Disease Control and Prevention administers the survey to a representative sample of the U.S. population. Children in each household are randomly sampled, and adult caregivers provide detailed health information about them.
Dr. Wan and her colleagues included children aged between 4 and 17 years in their analysis. The exposure of interest was eczema. Caregivers reported eczema in response to the question, “During the past 12 months, has the child had eczema or any kind of skin allergy?” The study’s primary outcome was mental health impairment. Using the Strengths and Difficulties Questionnaire (SDQ), the investigators categorized mental health impairment as none, mild, or severe. The SDQ is a validated instrument that assesses symptoms of mental health in children in domains such as conduct, emotion, peer relationships, and attention, which the researchers chose as secondary outcomes of interest. Dr. Wan’s group also examined the utilization of mental health and other health and social services among children with eczema.
The researchers performed logistic regression analysis to obtain odds ratios for mental health impairment among children with eczema, adjusting the analysis for potential socioeconomic and demographic confounders. Furthermore, they stratified the primary model by other atopic and behavioral disorders to assess for potential effects modification by these concomitant illnesses.
Approximately 12% of the children in the sample had eczema. Children with eczema tended to be female, non-Hispanic, or black; they also were more likely to report good, fair, or poor health, compared with children without eczema. Asthma, allergic rhinitis, and ADHD were more common among children with eczema than those without.
About 27% of children with eczema had any mental health impairment, compared with approximately 18% of children without eczema. About 11% of children with eczema had severe impairment; this rate was almost twice as high as that in children without eczema, Dr. Wan said. The adjusted odds of mental health impairment were 52% per year among children with eczema, compared with those without.
When the researchers examined specific domains of mental health, they found that children with eczema were significantly less likely to be reported to be well behaved or to have good attention spans. They also were significantly more likely to worry often, be unhappy or depressed, and to get along better with adults than their peers.
When Dr. Wan and his colleagues stratified the primary model by other atopic illnesses, they found that, among children without any other atopic illness, eczema remained independently associated with mental health impairment (OR, 1.52). The effect remained similar among children with asthma alone, but was attenuated among children with allergic rhinitis alone or with asthma and allergic rhinitis.
In the absence of ADHD, the investigators found a statistically significant effect of eczema on mental health impairment (OR, 1.46). In the presence of ADHD, the effect remained significant, but was attenuated.
Finally, approximately 20% of children with mildly impaired mental health had seen a mental health professional in the past year. In addition, 54% of children with severe mental health symptoms had seen a mental health professional in the past year. Among children with severe impairment, about 80% had consulted a general practitioner in the past year; 45% of them reported emotional or behavioral issues as the reason for the visit. Use of special education and early intervention services were more prevalent among children with increasing degrees of mental health impairment.
The study’s strengths include its population-based design, the use of a validated psychometric instrument, and the adjustment of data for socioeconomic factors and other comorbid illnesses, Dr. Wan said. The study is cross sectional, however, which precludes conclusions about the directionality of the relationship between eczema and mental health. In addition, the SDQ may not capture all mental health symptoms that eczema affects.
It is imperative that clinicians and caregivers recognize how common mental health impairment is among children with eczema so that children can be appropriately screened and referred for care, Dr. Wan said. “Our study suggests that there may be a critical gap in mental health services utilization by children who have eczema and concomitant mental health impairment. Some of the future directions in this area may be to understand the potential barriers to mental health care in children with eczema, and certainly to identify potentially effective interventions to reduce the mental health burden in pediatric eczema.”
Dr. Wan reported receiving research fellowship funding from Pfizer.
REPORTING FROM AAD 2019
Norwegian scabies
DIAGNOSIS, TREATMENT, CONTROL
The differential diagnosis of Norwegian scabies includes psoriasis, eczema, contact dermatitis, insect bites, seborrheic dermatitis, lichen planus, systemic infection, palmoplantar keratoderma, and cutaneous lymphoma.2
Treatment involves eradicating the infestation with a topical ointment consisting of permethrin, crotamiton, lindane, benzyl benzoate, and sulfur, applied directly to the skin. However, topical treatments often cannot penetrate the crusted and thickened skin, leading to treatment failure. A dose of oral ivermectin 200 µg/kg on days 1, 2, and 8 is a safe, effective, first-line treatment for Norwegian scabies, rapidly reducing scabies symptoms.3 Adverse effects of oral ivermectin are rare and usually minor.
Norwegian scabies is extremely contagious, spread by close physical contact and sharing of contaminated items such as clothing, bedding, towels, and furniture. Scabies mites can survive off the skin for 48 to 72 hours at room temperature.4 Potentially contaminated items should be decontaminated by washing in hot water and drying in a drying machine or by dry cleaning. Body contact with other contaminated items should be avoided for at least 72 hours.
Outbreaks can spread among patients, visitors, and medical staff in institutions such as nursing homes, day care centers, long-term-care facilities, and hospitals.5 Early identification facilitates appropriate management and treatment, thereby preventing infection and community-wide scabies outbreaks.
Acknowledgment: The authors would like to sincerely thank Paul Williams for his editing of the article.
- Leone PA. Scabies and pediculosis pubis: an update of treatment regimens and general review. Clin Infect Dis 2007; 44(suppl 3):S153–S159. doi:10.1086/511428
- Siegfried EC, Hebert AA. Diagnosis of atopic dermatitis: mimics, overlaps, and complications. J Clin Med 2015; 4(5):884–917. doi:10.3390/jcm4050884
- Salavastru CM, Chosidow O, Boffa MJ, Janier M, Tiplica GS. European guideline for the management of scabies. J Eur Acad Dermatol Venereol 2017; 31(8):1248–1253. doi:10.1111/jdv.14351
- Khalil S, Abbas O, Kibbi AG, Kurban M. Scabies in the age of increasing drug resistance. PLoS Negl Trop Dis 2017; 11(11):e0005920. doi:10.1371/journal.pntd.0005920
- Anderson KL, Strowd LC. Epidemiology, diagnosis, and treatment of scabies in a dermatology office. J Am Board Fam Med 2017; 30(1):78–84. doi:10.3122/jabfm.2017.01.160190
DIAGNOSIS, TREATMENT, CONTROL
The differential diagnosis of Norwegian scabies includes psoriasis, eczema, contact dermatitis, insect bites, seborrheic dermatitis, lichen planus, systemic infection, palmoplantar keratoderma, and cutaneous lymphoma.2
Treatment involves eradicating the infestation with a topical ointment consisting of permethrin, crotamiton, lindane, benzyl benzoate, and sulfur, applied directly to the skin. However, topical treatments often cannot penetrate the crusted and thickened skin, leading to treatment failure. A dose of oral ivermectin 200 µg/kg on days 1, 2, and 8 is a safe, effective, first-line treatment for Norwegian scabies, rapidly reducing scabies symptoms.3 Adverse effects of oral ivermectin are rare and usually minor.
Norwegian scabies is extremely contagious, spread by close physical contact and sharing of contaminated items such as clothing, bedding, towels, and furniture. Scabies mites can survive off the skin for 48 to 72 hours at room temperature.4 Potentially contaminated items should be decontaminated by washing in hot water and drying in a drying machine or by dry cleaning. Body contact with other contaminated items should be avoided for at least 72 hours.
Outbreaks can spread among patients, visitors, and medical staff in institutions such as nursing homes, day care centers, long-term-care facilities, and hospitals.5 Early identification facilitates appropriate management and treatment, thereby preventing infection and community-wide scabies outbreaks.
Acknowledgment: The authors would like to sincerely thank Paul Williams for his editing of the article.
DIAGNOSIS, TREATMENT, CONTROL
The differential diagnosis of Norwegian scabies includes psoriasis, eczema, contact dermatitis, insect bites, seborrheic dermatitis, lichen planus, systemic infection, palmoplantar keratoderma, and cutaneous lymphoma.2
Treatment involves eradicating the infestation with a topical ointment consisting of permethrin, crotamiton, lindane, benzyl benzoate, and sulfur, applied directly to the skin. However, topical treatments often cannot penetrate the crusted and thickened skin, leading to treatment failure. A dose of oral ivermectin 200 µg/kg on days 1, 2, and 8 is a safe, effective, first-line treatment for Norwegian scabies, rapidly reducing scabies symptoms.3 Adverse effects of oral ivermectin are rare and usually minor.
Norwegian scabies is extremely contagious, spread by close physical contact and sharing of contaminated items such as clothing, bedding, towels, and furniture. Scabies mites can survive off the skin for 48 to 72 hours at room temperature.4 Potentially contaminated items should be decontaminated by washing in hot water and drying in a drying machine or by dry cleaning. Body contact with other contaminated items should be avoided for at least 72 hours.
Outbreaks can spread among patients, visitors, and medical staff in institutions such as nursing homes, day care centers, long-term-care facilities, and hospitals.5 Early identification facilitates appropriate management and treatment, thereby preventing infection and community-wide scabies outbreaks.
Acknowledgment: The authors would like to sincerely thank Paul Williams for his editing of the article.
- Leone PA. Scabies and pediculosis pubis: an update of treatment regimens and general review. Clin Infect Dis 2007; 44(suppl 3):S153–S159. doi:10.1086/511428
- Siegfried EC, Hebert AA. Diagnosis of atopic dermatitis: mimics, overlaps, and complications. J Clin Med 2015; 4(5):884–917. doi:10.3390/jcm4050884
- Salavastru CM, Chosidow O, Boffa MJ, Janier M, Tiplica GS. European guideline for the management of scabies. J Eur Acad Dermatol Venereol 2017; 31(8):1248–1253. doi:10.1111/jdv.14351
- Khalil S, Abbas O, Kibbi AG, Kurban M. Scabies in the age of increasing drug resistance. PLoS Negl Trop Dis 2017; 11(11):e0005920. doi:10.1371/journal.pntd.0005920
- Anderson KL, Strowd LC. Epidemiology, diagnosis, and treatment of scabies in a dermatology office. J Am Board Fam Med 2017; 30(1):78–84. doi:10.3122/jabfm.2017.01.160190
- Leone PA. Scabies and pediculosis pubis: an update of treatment regimens and general review. Clin Infect Dis 2007; 44(suppl 3):S153–S159. doi:10.1086/511428
- Siegfried EC, Hebert AA. Diagnosis of atopic dermatitis: mimics, overlaps, and complications. J Clin Med 2015; 4(5):884–917. doi:10.3390/jcm4050884
- Salavastru CM, Chosidow O, Boffa MJ, Janier M, Tiplica GS. European guideline for the management of scabies. J Eur Acad Dermatol Venereol 2017; 31(8):1248–1253. doi:10.1111/jdv.14351
- Khalil S, Abbas O, Kibbi AG, Kurban M. Scabies in the age of increasing drug resistance. PLoS Negl Trop Dis 2017; 11(11):e0005920. doi:10.1371/journal.pntd.0005920
- Anderson KL, Strowd LC. Epidemiology, diagnosis, and treatment of scabies in a dermatology office. J Am Board Fam Med 2017; 30(1):78–84. doi:10.3122/jabfm.2017.01.160190
The Case of the Disappearing Eyebrows
When this 45-year-old man was in third grade, he began to notice areas of hair loss in his scalp. The affected area was always round and the hair loss complete—but it would grow back entirely within weeks to months. There was never any rash or discomfort associated with these changes.
Since then, he has experienced numerous similar episodes of focal hair loss, sometimes in the beard, sometimes on the arms or legs, and most recently, in his eyebrows. Again, no symptoms accompany the process.
Although his personal health history is relatively uneventful, his family has not been as fortunate. There are numerous cases of lupus, rheumatoid arthritis, diabetes, and thyroid disease.
EXAMINATION
There are sharply defined, crescent-shaped, 2.5-cm divots at the superior borders of both eyebrows in which every hair is gone. No redness, swelling, or scaling are seen or felt, and there is no detectable adenopathy in the region.
Examination of hair-bearing regions reveals no other areas of hair loss.
What’s the diagnosis?
DISCUSSION
This case illustrates several variants of an extremely common condition: alopecia areata (AA), literally translated as “hair loss confined to a particular localized area or areas.” Although AA is more common in adults, it often affects children. And though the scalp is by far the most commonly affected area, AA can cause hair loss anywhere on the body.
In general, the earlier the onset, the more likely the problem is to become recurrent or even progressive. In rare instances, a patient can develop alopecia totalis, in which there is permanent and total scalp hair loss, or even alopecia universalis, the permanent loss of every hair on the entire body. Other predictors of a poor prognosis include extensive involvement of the scalp, especially the periphery (termed ophiasis), and a history of atopy.
Much research has been done on the underlying pathology of AA, as well as potential remedies. This has proven, beyond any doubt, that the problem is autoimmune and tends to run in families (as with other autoimmune diseases), suggesting a hereditary basis. We also know that medications that dampen this autoimmune process, such as steroids and biologics, are useful but not always safe or practical.
What we don’t really know is what triggers an actual attack. My observation, based on 35 years of dermatology practice, is that stress often plays a part—but I’d be hard pressed to prove that, and it wouldn’t be very useful even if I could. This patient adamantly agreed that stress was the trigger for his AA.
The differential for AA includes tinea capitis, discoid lupus, and lichen planopilaris. This patient’s multiple episodes over decades made the correct diagnosis clear. However, when the diagnosis is in doubt—other items in the differential commonly affect the scalp, although they may also manifest with redness, scaling, or swelling—a punch biopsy may be necessary to sort through the possibilities. Care must be taken to enter the skin parallel to hair follicles when the sample is removed.
Many treatments have been tried for AA, but none are reliably effective. In the vast majority of patients, the problem resolves itself. Treatments to try when needed include topical steroids, intralesional steroids, and topical immune stimulators (eg, squaric acid or dinitrochlorobenzene)—all of which have their limitations.
TAKE-HOME LEARNING POINTS
- Alopecia areata (AA) is more common in adults but can affect children as well.
- In rare cases, the patient can experience permanent total hair loss on the scalp (alopecia totalis) or the entire body (alopecia universalis).
- Because AA is an autoimmune disease, steroids and biologics may be useful treatments—but they are not always safe or practical.
- In a majority of patients with AA, the problem will resolve on its own.
When this 45-year-old man was in third grade, he began to notice areas of hair loss in his scalp. The affected area was always round and the hair loss complete—but it would grow back entirely within weeks to months. There was never any rash or discomfort associated with these changes.
Since then, he has experienced numerous similar episodes of focal hair loss, sometimes in the beard, sometimes on the arms or legs, and most recently, in his eyebrows. Again, no symptoms accompany the process.
Although his personal health history is relatively uneventful, his family has not been as fortunate. There are numerous cases of lupus, rheumatoid arthritis, diabetes, and thyroid disease.
EXAMINATION
There are sharply defined, crescent-shaped, 2.5-cm divots at the superior borders of both eyebrows in which every hair is gone. No redness, swelling, or scaling are seen or felt, and there is no detectable adenopathy in the region.
Examination of hair-bearing regions reveals no other areas of hair loss.
What’s the diagnosis?
DISCUSSION
This case illustrates several variants of an extremely common condition: alopecia areata (AA), literally translated as “hair loss confined to a particular localized area or areas.” Although AA is more common in adults, it often affects children. And though the scalp is by far the most commonly affected area, AA can cause hair loss anywhere on the body.
In general, the earlier the onset, the more likely the problem is to become recurrent or even progressive. In rare instances, a patient can develop alopecia totalis, in which there is permanent and total scalp hair loss, or even alopecia universalis, the permanent loss of every hair on the entire body. Other predictors of a poor prognosis include extensive involvement of the scalp, especially the periphery (termed ophiasis), and a history of atopy.
Much research has been done on the underlying pathology of AA, as well as potential remedies. This has proven, beyond any doubt, that the problem is autoimmune and tends to run in families (as with other autoimmune diseases), suggesting a hereditary basis. We also know that medications that dampen this autoimmune process, such as steroids and biologics, are useful but not always safe or practical.
What we don’t really know is what triggers an actual attack. My observation, based on 35 years of dermatology practice, is that stress often plays a part—but I’d be hard pressed to prove that, and it wouldn’t be very useful even if I could. This patient adamantly agreed that stress was the trigger for his AA.
The differential for AA includes tinea capitis, discoid lupus, and lichen planopilaris. This patient’s multiple episodes over decades made the correct diagnosis clear. However, when the diagnosis is in doubt—other items in the differential commonly affect the scalp, although they may also manifest with redness, scaling, or swelling—a punch biopsy may be necessary to sort through the possibilities. Care must be taken to enter the skin parallel to hair follicles when the sample is removed.
Many treatments have been tried for AA, but none are reliably effective. In the vast majority of patients, the problem resolves itself. Treatments to try when needed include topical steroids, intralesional steroids, and topical immune stimulators (eg, squaric acid or dinitrochlorobenzene)—all of which have their limitations.
TAKE-HOME LEARNING POINTS
- Alopecia areata (AA) is more common in adults but can affect children as well.
- In rare cases, the patient can experience permanent total hair loss on the scalp (alopecia totalis) or the entire body (alopecia universalis).
- Because AA is an autoimmune disease, steroids and biologics may be useful treatments—but they are not always safe or practical.
- In a majority of patients with AA, the problem will resolve on its own.
When this 45-year-old man was in third grade, he began to notice areas of hair loss in his scalp. The affected area was always round and the hair loss complete—but it would grow back entirely within weeks to months. There was never any rash or discomfort associated with these changes.
Since then, he has experienced numerous similar episodes of focal hair loss, sometimes in the beard, sometimes on the arms or legs, and most recently, in his eyebrows. Again, no symptoms accompany the process.
Although his personal health history is relatively uneventful, his family has not been as fortunate. There are numerous cases of lupus, rheumatoid arthritis, diabetes, and thyroid disease.
EXAMINATION
There are sharply defined, crescent-shaped, 2.5-cm divots at the superior borders of both eyebrows in which every hair is gone. No redness, swelling, or scaling are seen or felt, and there is no detectable adenopathy in the region.
Examination of hair-bearing regions reveals no other areas of hair loss.
What’s the diagnosis?
DISCUSSION
This case illustrates several variants of an extremely common condition: alopecia areata (AA), literally translated as “hair loss confined to a particular localized area or areas.” Although AA is more common in adults, it often affects children. And though the scalp is by far the most commonly affected area, AA can cause hair loss anywhere on the body.
In general, the earlier the onset, the more likely the problem is to become recurrent or even progressive. In rare instances, a patient can develop alopecia totalis, in which there is permanent and total scalp hair loss, or even alopecia universalis, the permanent loss of every hair on the entire body. Other predictors of a poor prognosis include extensive involvement of the scalp, especially the periphery (termed ophiasis), and a history of atopy.
Much research has been done on the underlying pathology of AA, as well as potential remedies. This has proven, beyond any doubt, that the problem is autoimmune and tends to run in families (as with other autoimmune diseases), suggesting a hereditary basis. We also know that medications that dampen this autoimmune process, such as steroids and biologics, are useful but not always safe or practical.
What we don’t really know is what triggers an actual attack. My observation, based on 35 years of dermatology practice, is that stress often plays a part—but I’d be hard pressed to prove that, and it wouldn’t be very useful even if I could. This patient adamantly agreed that stress was the trigger for his AA.
The differential for AA includes tinea capitis, discoid lupus, and lichen planopilaris. This patient’s multiple episodes over decades made the correct diagnosis clear. However, when the diagnosis is in doubt—other items in the differential commonly affect the scalp, although they may also manifest with redness, scaling, or swelling—a punch biopsy may be necessary to sort through the possibilities. Care must be taken to enter the skin parallel to hair follicles when the sample is removed.
Many treatments have been tried for AA, but none are reliably effective. In the vast majority of patients, the problem resolves itself. Treatments to try when needed include topical steroids, intralesional steroids, and topical immune stimulators (eg, squaric acid or dinitrochlorobenzene)—all of which have their limitations.
TAKE-HOME LEARNING POINTS
- Alopecia areata (AA) is more common in adults but can affect children as well.
- In rare cases, the patient can experience permanent total hair loss on the scalp (alopecia totalis) or the entire body (alopecia universalis).
- Because AA is an autoimmune disease, steroids and biologics may be useful treatments—but they are not always safe or practical.
- In a majority of patients with AA, the problem will resolve on its own.
Growing spot on nose
The FP was concerned that this could be melanoma.
He used his dermatoscope and saw suspicious patterns that included polygonal lines and circle-within-circle patterns. He informed the patient about his concerns for melanoma and discussed the need for a biopsy. After obtaining informed consent, the FP injected the patient’s nose with 1% lidocaine and epinephrine for anesthesia and to prevent bleeding. Remember, it is safe to use injectable epinephrine along with lidocaine when doing surgery on the nose. (See “Biopsies for skin cancer detection: Dispelling the myths”). The FP used a Dermablade to perform a broad shave biopsy, which revealed a lentigo maligna melanoma in situ (also known as lentigo maligna). (See the Watch & Learn video on “Shave biopsy”)
During the follow-up visit, the FP presented the patient with 2 options for treatment: topical imiquimod for 3 months or Mohs surgery. The FP recommended Mohs surgery because the data for topical imiquimod in the treatment of lentigo maligna indicate that it is less effective on the nose than other areas of the face. The patient agreed to surgery, and the FP sent the referral and the photo of the original lesion to the Mohs surgeon. The outcome was good, and the need for ongoing sun safety and regular skin surveillance was explained to the patient.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine, 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.
To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/
You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com
The FP was concerned that this could be melanoma.
He used his dermatoscope and saw suspicious patterns that included polygonal lines and circle-within-circle patterns. He informed the patient about his concerns for melanoma and discussed the need for a biopsy. After obtaining informed consent, the FP injected the patient’s nose with 1% lidocaine and epinephrine for anesthesia and to prevent bleeding. Remember, it is safe to use injectable epinephrine along with lidocaine when doing surgery on the nose. (See “Biopsies for skin cancer detection: Dispelling the myths”). The FP used a Dermablade to perform a broad shave biopsy, which revealed a lentigo maligna melanoma in situ (also known as lentigo maligna). (See the Watch & Learn video on “Shave biopsy”)
During the follow-up visit, the FP presented the patient with 2 options for treatment: topical imiquimod for 3 months or Mohs surgery. The FP recommended Mohs surgery because the data for topical imiquimod in the treatment of lentigo maligna indicate that it is less effective on the nose than other areas of the face. The patient agreed to surgery, and the FP sent the referral and the photo of the original lesion to the Mohs surgeon. The outcome was good, and the need for ongoing sun safety and regular skin surveillance was explained to the patient.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine, 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.
To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/
You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com
The FP was concerned that this could be melanoma.
He used his dermatoscope and saw suspicious patterns that included polygonal lines and circle-within-circle patterns. He informed the patient about his concerns for melanoma and discussed the need for a biopsy. After obtaining informed consent, the FP injected the patient’s nose with 1% lidocaine and epinephrine for anesthesia and to prevent bleeding. Remember, it is safe to use injectable epinephrine along with lidocaine when doing surgery on the nose. (See “Biopsies for skin cancer detection: Dispelling the myths”). The FP used a Dermablade to perform a broad shave biopsy, which revealed a lentigo maligna melanoma in situ (also known as lentigo maligna). (See the Watch & Learn video on “Shave biopsy”)
During the follow-up visit, the FP presented the patient with 2 options for treatment: topical imiquimod for 3 months or Mohs surgery. The FP recommended Mohs surgery because the data for topical imiquimod in the treatment of lentigo maligna indicate that it is less effective on the nose than other areas of the face. The patient agreed to surgery, and the FP sent the referral and the photo of the original lesion to the Mohs surgeon. The outcome was good, and the need for ongoing sun safety and regular skin surveillance was explained to the patient.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Melanoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas and Synopsis of Family Medicine, 3rd ed. New York, NY: McGraw-Hill; 2019:1112-1123.
To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/
You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com
Rhymin’ pediatric dermatologist provides Demodex tips
WAIKOLOA, HAWAII – Pediatric dermatologist Andrea L. Zaenglein, MD, has composed a whimsical couplet to help physicians broaden their differential diagnosis for acneiform rashes in children.
Pustules on noses: Think demodicosis!
The classic teaching has been that Demodex carriage and its pathologic clinical expression, demodicosis, are rare in children. Not so, Dr. Zaenglein asserted at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“One of the things that we never used to see in kids but now I see all the time, probably because I’m looking for it, is Demodex. You’re not born with Demodex. Your carriage rate will increase over the years and by the time you’re elderly, 95% of us will have it – but not me. I just decided I’m not having these. I’m not looking for them, and I don’t want to know if they’re there,” she quipped, referring to the creepiness factor surrounding these facial parasitic mites invisible to the naked eye.
The mites live in pilosebaceous units. In animals, the disease is called mange. In humans, demodicosis is caused by two species of mites: Demodex folliculorum and D. brevis. The diagnosis is made by microscopic examination of mineral oil skin scrapings.
Primary demodicosis can take the form of pityriasis folliculorum, also known as spinulate demodicosis, papulopustular perioral, periauricular, or periorbital demodicosis, or a nodulocystic/conglobate version.
More commonly, however, .
“Demodicosis can be associated with immunosuppression. Kids with Langerhans cell histiocytosis seem to be prone to it. But you can see it in kids who don’t have any underlying immunosuppression, and I think there are more and more cases of that as we go looking for it,” said Dr. Zaenglein, professor of dermatology and pediatrics at Penn State University, Hershey, and immediate past president of the Society for Pediatric Dermatology.
Look for Demodex in children with somewhat atypical versions of common acneiform eruptions: for example, the ‘pustules on noses’ variant.
“Finding Demodex can alter your treatment and make it easier in these cases,” she said.
Metronidazole and ivermectin are the systemic treatment options for pediatric demodicosis.
“I tend to use topical permethrin, just because it’s easy to get. I’ll treat them once a week for 3 weeks in a row. But also make sure to treat the underlying primary inflammatory disorder,” the pediatric dermatologist advised.
Other topical options include ivermectin cream, crotamiton cream, metronidazole gel, and salicylic acid cream.
Dr. Zaenglein reported having financial relationships with Sun Pharmaceuticals, Allergan, and Ortho Dermatologics.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – Pediatric dermatologist Andrea L. Zaenglein, MD, has composed a whimsical couplet to help physicians broaden their differential diagnosis for acneiform rashes in children.
Pustules on noses: Think demodicosis!
The classic teaching has been that Demodex carriage and its pathologic clinical expression, demodicosis, are rare in children. Not so, Dr. Zaenglein asserted at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“One of the things that we never used to see in kids but now I see all the time, probably because I’m looking for it, is Demodex. You’re not born with Demodex. Your carriage rate will increase over the years and by the time you’re elderly, 95% of us will have it – but not me. I just decided I’m not having these. I’m not looking for them, and I don’t want to know if they’re there,” she quipped, referring to the creepiness factor surrounding these facial parasitic mites invisible to the naked eye.
The mites live in pilosebaceous units. In animals, the disease is called mange. In humans, demodicosis is caused by two species of mites: Demodex folliculorum and D. brevis. The diagnosis is made by microscopic examination of mineral oil skin scrapings.
Primary demodicosis can take the form of pityriasis folliculorum, also known as spinulate demodicosis, papulopustular perioral, periauricular, or periorbital demodicosis, or a nodulocystic/conglobate version.
More commonly, however, .
“Demodicosis can be associated with immunosuppression. Kids with Langerhans cell histiocytosis seem to be prone to it. But you can see it in kids who don’t have any underlying immunosuppression, and I think there are more and more cases of that as we go looking for it,” said Dr. Zaenglein, professor of dermatology and pediatrics at Penn State University, Hershey, and immediate past president of the Society for Pediatric Dermatology.
Look for Demodex in children with somewhat atypical versions of common acneiform eruptions: for example, the ‘pustules on noses’ variant.
“Finding Demodex can alter your treatment and make it easier in these cases,” she said.
Metronidazole and ivermectin are the systemic treatment options for pediatric demodicosis.
“I tend to use topical permethrin, just because it’s easy to get. I’ll treat them once a week for 3 weeks in a row. But also make sure to treat the underlying primary inflammatory disorder,” the pediatric dermatologist advised.
Other topical options include ivermectin cream, crotamiton cream, metronidazole gel, and salicylic acid cream.
Dr. Zaenglein reported having financial relationships with Sun Pharmaceuticals, Allergan, and Ortho Dermatologics.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – Pediatric dermatologist Andrea L. Zaenglein, MD, has composed a whimsical couplet to help physicians broaden their differential diagnosis for acneiform rashes in children.
Pustules on noses: Think demodicosis!
The classic teaching has been that Demodex carriage and its pathologic clinical expression, demodicosis, are rare in children. Not so, Dr. Zaenglein asserted at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“One of the things that we never used to see in kids but now I see all the time, probably because I’m looking for it, is Demodex. You’re not born with Demodex. Your carriage rate will increase over the years and by the time you’re elderly, 95% of us will have it – but not me. I just decided I’m not having these. I’m not looking for them, and I don’t want to know if they’re there,” she quipped, referring to the creepiness factor surrounding these facial parasitic mites invisible to the naked eye.
The mites live in pilosebaceous units. In animals, the disease is called mange. In humans, demodicosis is caused by two species of mites: Demodex folliculorum and D. brevis. The diagnosis is made by microscopic examination of mineral oil skin scrapings.
Primary demodicosis can take the form of pityriasis folliculorum, also known as spinulate demodicosis, papulopustular perioral, periauricular, or periorbital demodicosis, or a nodulocystic/conglobate version.
More commonly, however, .
“Demodicosis can be associated with immunosuppression. Kids with Langerhans cell histiocytosis seem to be prone to it. But you can see it in kids who don’t have any underlying immunosuppression, and I think there are more and more cases of that as we go looking for it,” said Dr. Zaenglein, professor of dermatology and pediatrics at Penn State University, Hershey, and immediate past president of the Society for Pediatric Dermatology.
Look for Demodex in children with somewhat atypical versions of common acneiform eruptions: for example, the ‘pustules on noses’ variant.
“Finding Demodex can alter your treatment and make it easier in these cases,” she said.
Metronidazole and ivermectin are the systemic treatment options for pediatric demodicosis.
“I tend to use topical permethrin, just because it’s easy to get. I’ll treat them once a week for 3 weeks in a row. But also make sure to treat the underlying primary inflammatory disorder,” the pediatric dermatologist advised.
Other topical options include ivermectin cream, crotamiton cream, metronidazole gel, and salicylic acid cream.
Dr. Zaenglein reported having financial relationships with Sun Pharmaceuticals, Allergan, and Ortho Dermatologics.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
REPORTING FROM SDEF HAWAII DERMATOLOGY SEMINAR
FDA: Safety signal emerged with higher dose of tofacitinib in RA study
the Food and Drug Administration reported.
The trial’s Data Safety and Monitoring Board identified the signal in patients taking a 10-mg dose of tofacitinib twice daily, the FDA said in a safety announcement.
Pfizer, the trial’s sponsor, took “immediate action” to transition patients in the ongoing trial from the 10-mg, twice-daily dose to 5 mg twice daily, which is the approved dose for adult patients with moderate to severe rheumatoid arthritis, the agency said. The 10-mg, twice-daily dose is approved only in the dosing regimen for patients with ulcerative colitis. Xeljanz is also approved to treat psoriatic arthritis. The 11-mg, once-daily dose of Xeljanz XR that is approved to treat rheumatoid arthritis and psoriatic arthritis was not tested in the trial.
The ongoing study was designed to assess risks of cardiovascular events, cancer, and opportunistic infections with tofacitinib 10 mg twice daily or 5 mg twice daily versus the risks in a control group treated with a tumor necrosis factor (TNF) inhibitor, according to the statement.
Patients had to be 50 years of age or older and have at least one cardiovascular risk factor to be eligible for the study, which was required by the agency in 2012 when it approved tofacitinib, the statement says.
The FDA is reviewing trial data and working with Pfizer to better understand the safety signal, its effect on patients, and how tofacitinib should be used, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. The trial will continue and is expected to be completed by the end of 2019.
“The agency will take appropriate action, as warranted, to ensure patients enrolled in this and other trials are protected and that health care professionals and clinical trial researchers understand the risks associated with this use,” she added.
Health care professionals should follow tofacitinib prescribing information, monitor patients for the signs and symptoms of pulmonary embolism, and advise patients to seek medical attention immediately if they experience those signs and symptoms, according to the statement.
“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” Dr. Woodcock said in the release.
While not approved in rheumatoid arthritis, the 10-mg, twice-daily dose of tofacitinib is approved in the dosing regimen for patients with ulcerative colitis, the release says.
the Food and Drug Administration reported.
The trial’s Data Safety and Monitoring Board identified the signal in patients taking a 10-mg dose of tofacitinib twice daily, the FDA said in a safety announcement.
Pfizer, the trial’s sponsor, took “immediate action” to transition patients in the ongoing trial from the 10-mg, twice-daily dose to 5 mg twice daily, which is the approved dose for adult patients with moderate to severe rheumatoid arthritis, the agency said. The 10-mg, twice-daily dose is approved only in the dosing regimen for patients with ulcerative colitis. Xeljanz is also approved to treat psoriatic arthritis. The 11-mg, once-daily dose of Xeljanz XR that is approved to treat rheumatoid arthritis and psoriatic arthritis was not tested in the trial.
The ongoing study was designed to assess risks of cardiovascular events, cancer, and opportunistic infections with tofacitinib 10 mg twice daily or 5 mg twice daily versus the risks in a control group treated with a tumor necrosis factor (TNF) inhibitor, according to the statement.
Patients had to be 50 years of age or older and have at least one cardiovascular risk factor to be eligible for the study, which was required by the agency in 2012 when it approved tofacitinib, the statement says.
The FDA is reviewing trial data and working with Pfizer to better understand the safety signal, its effect on patients, and how tofacitinib should be used, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. The trial will continue and is expected to be completed by the end of 2019.
“The agency will take appropriate action, as warranted, to ensure patients enrolled in this and other trials are protected and that health care professionals and clinical trial researchers understand the risks associated with this use,” she added.
Health care professionals should follow tofacitinib prescribing information, monitor patients for the signs and symptoms of pulmonary embolism, and advise patients to seek medical attention immediately if they experience those signs and symptoms, according to the statement.
“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” Dr. Woodcock said in the release.
While not approved in rheumatoid arthritis, the 10-mg, twice-daily dose of tofacitinib is approved in the dosing regimen for patients with ulcerative colitis, the release says.
the Food and Drug Administration reported.
The trial’s Data Safety and Monitoring Board identified the signal in patients taking a 10-mg dose of tofacitinib twice daily, the FDA said in a safety announcement.
Pfizer, the trial’s sponsor, took “immediate action” to transition patients in the ongoing trial from the 10-mg, twice-daily dose to 5 mg twice daily, which is the approved dose for adult patients with moderate to severe rheumatoid arthritis, the agency said. The 10-mg, twice-daily dose is approved only in the dosing regimen for patients with ulcerative colitis. Xeljanz is also approved to treat psoriatic arthritis. The 11-mg, once-daily dose of Xeljanz XR that is approved to treat rheumatoid arthritis and psoriatic arthritis was not tested in the trial.
The ongoing study was designed to assess risks of cardiovascular events, cancer, and opportunistic infections with tofacitinib 10 mg twice daily or 5 mg twice daily versus the risks in a control group treated with a tumor necrosis factor (TNF) inhibitor, according to the statement.
Patients had to be 50 years of age or older and have at least one cardiovascular risk factor to be eligible for the study, which was required by the agency in 2012 when it approved tofacitinib, the statement says.
The FDA is reviewing trial data and working with Pfizer to better understand the safety signal, its effect on patients, and how tofacitinib should be used, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a news release. The trial will continue and is expected to be completed by the end of 2019.
“The agency will take appropriate action, as warranted, to ensure patients enrolled in this and other trials are protected and that health care professionals and clinical trial researchers understand the risks associated with this use,” she added.
Health care professionals should follow tofacitinib prescribing information, monitor patients for the signs and symptoms of pulmonary embolism, and advise patients to seek medical attention immediately if they experience those signs and symptoms, according to the statement.
“We are communicating now, given the serious nature of the safety issue, to ensure that patients taking tofacitinib are aware that the FDA still believes the benefits of taking tofacitinib for its approved uses continue to outweigh the risks,” Dr. Woodcock said in the release.
While not approved in rheumatoid arthritis, the 10-mg, twice-daily dose of tofacitinib is approved in the dosing regimen for patients with ulcerative colitis, the release says.
FDA: More safety data needed for 12 sunscreen active ingredients
including some of those frequently used in over-the-counter products.
The ingredients requiring additional investigation are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The FDA actions were announced during a press briefing Feb. 21 held to discuss the proposed rule to update regulatory requirements for most sunscreen products marketed in the United States.
There are no urgent safety matters associated with these ingredients. The rule is part of FDA’s charge to construct an over-the-counter (OTC) monograph detailing all available data on sunscreen ingredients, as required by the Sunscreen Innovation Act.
OTC monographs establish conditions under which ingredients may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) “and not misbranded,” according to the FDA. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).
“We are proposing that these ingredients require additional data before a positive GRASE determination can be made,” FDA press officer Sandy Walsh said in an interview, referring to the 12 ingredients. “This proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”
Among its provisions, the proposal addresses sunscreen active-ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information
Thus far, the agency says that only two active ingredients – titanium dioxide and zinc oxide – can be marketed without approved new drug applications because they are GRASE.
However, two other ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. Products that combine sunscreen and insect repellent also not fit the criteria, she said
“There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data,” she said.
In addition to seeking these additional data, the rule also proposes the following:
- Dosage forms that are GRASE for use as sunscreens should include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. While powders are proposed to be eligible for inclusion in the monograph, more data are being requested before powders are included. “Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph,” according to the FDA statement outlining the proposed regulation.
- The maximum proposed SPF value on sunscreen labels should be raised from SPF 50 or higher to SPF 60 or higher. “There are not enough data to suggest that consumers get any extra benefit from products with an SPF of more than 60,” Dr. Michele said.
- Sunscreens with an SPF value of 15 or higher should be required to also provide broad-spectrum protection, and for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation should also increase. “These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the statement said.
- New sunscreen product labels should be required to make it easier for consumers to identify important information, “including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum, and water resistance statements,” the statement said.
- Products that combine sunscreens with insect repellents are not GRASE.
In the meantime, though, consumers should continue to use sunscreens regularly as part of a comprehensive sun protection program, FDA Commissioner Scott Gottlieb, MD, said during the briefing. “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” he continued. “Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreens in conjunction with other sun protective measures (such as protective clothing) as this important rule-making effort moves forward.”
To submit comments on this proposed rule, go to https://www.regulations.gov and follow instructions for submitting comments.
including some of those frequently used in over-the-counter products.
The ingredients requiring additional investigation are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The FDA actions were announced during a press briefing Feb. 21 held to discuss the proposed rule to update regulatory requirements for most sunscreen products marketed in the United States.
There are no urgent safety matters associated with these ingredients. The rule is part of FDA’s charge to construct an over-the-counter (OTC) monograph detailing all available data on sunscreen ingredients, as required by the Sunscreen Innovation Act.
OTC monographs establish conditions under which ingredients may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) “and not misbranded,” according to the FDA. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).
“We are proposing that these ingredients require additional data before a positive GRASE determination can be made,” FDA press officer Sandy Walsh said in an interview, referring to the 12 ingredients. “This proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”
Among its provisions, the proposal addresses sunscreen active-ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information
Thus far, the agency says that only two active ingredients – titanium dioxide and zinc oxide – can be marketed without approved new drug applications because they are GRASE.
However, two other ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. Products that combine sunscreen and insect repellent also not fit the criteria, she said
“There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data,” she said.
In addition to seeking these additional data, the rule also proposes the following:
- Dosage forms that are GRASE for use as sunscreens should include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. While powders are proposed to be eligible for inclusion in the monograph, more data are being requested before powders are included. “Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph,” according to the FDA statement outlining the proposed regulation.
- The maximum proposed SPF value on sunscreen labels should be raised from SPF 50 or higher to SPF 60 or higher. “There are not enough data to suggest that consumers get any extra benefit from products with an SPF of more than 60,” Dr. Michele said.
- Sunscreens with an SPF value of 15 or higher should be required to also provide broad-spectrum protection, and for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation should also increase. “These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the statement said.
- New sunscreen product labels should be required to make it easier for consumers to identify important information, “including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum, and water resistance statements,” the statement said.
- Products that combine sunscreens with insect repellents are not GRASE.
In the meantime, though, consumers should continue to use sunscreens regularly as part of a comprehensive sun protection program, FDA Commissioner Scott Gottlieb, MD, said during the briefing. “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” he continued. “Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreens in conjunction with other sun protective measures (such as protective clothing) as this important rule-making effort moves forward.”
To submit comments on this proposed rule, go to https://www.regulations.gov and follow instructions for submitting comments.
including some of those frequently used in over-the-counter products.
The ingredients requiring additional investigation are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone. The FDA actions were announced during a press briefing Feb. 21 held to discuss the proposed rule to update regulatory requirements for most sunscreen products marketed in the United States.
There are no urgent safety matters associated with these ingredients. The rule is part of FDA’s charge to construct an over-the-counter (OTC) monograph detailing all available data on sunscreen ingredients, as required by the Sunscreen Innovation Act.
OTC monographs establish conditions under which ingredients may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) “and not misbranded,” according to the FDA. The proposed rule classifies active ingredients and other conditions as Category I (proposed to be GRASE and not misbranded), Category II (proposed to be not GRASE or to be misbranded), or Category III (additional data needed).
“We are proposing that these ingredients require additional data before a positive GRASE determination can be made,” FDA press officer Sandy Walsh said in an interview, referring to the 12 ingredients. “This proposed rule does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.”
Among its provisions, the proposal addresses sunscreen active-ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information
Thus far, the agency says that only two active ingredients – titanium dioxide and zinc oxide – can be marketed without approved new drug applications because they are GRASE.
However, two other ingredients – PABA and trolamine salicylate – are not GRASE for use in sunscreens because of safety issues, Theresa Michele, MD, director of the Division of Nonprescription Drug Products Division of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research. Products that combine sunscreen and insect repellent also not fit the criteria, she said
“There are 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time. To address these 12 ingredients, the FDA is asking industry and other interested parties for additional data. The FDA is working closely with industry and has published several guidances to make sure companies understand what data the agency believes is necessary for the FDA to evaluate safety and effectiveness for sunscreen active ingredients, including the 12 ingredients for which the FDA is seeking more data,” she said.
In addition to seeking these additional data, the rule also proposes the following:
- Dosage forms that are GRASE for use as sunscreens should include sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks. While powders are proposed to be eligible for inclusion in the monograph, more data are being requested before powders are included. “Wipes, towelettes, body washes, shampoos, and other dosage forms are proposed to be categorized as new drugs because the FDA has not received data showing they are eligible for inclusion in the monograph,” according to the FDA statement outlining the proposed regulation.
- The maximum proposed SPF value on sunscreen labels should be raised from SPF 50 or higher to SPF 60 or higher. “There are not enough data to suggest that consumers get any extra benefit from products with an SPF of more than 60,” Dr. Michele said.
- Sunscreens with an SPF value of 15 or higher should be required to also provide broad-spectrum protection, and for broad-spectrum products, as SPF increases, the magnitude of protection against UVA radiation should also increase. “These proposals are designed to ensure that these products provide consumers with the protections that they expect,” the statement said.
- New sunscreen product labels should be required to make it easier for consumers to identify important information, “including the addition of the active ingredients on the front of the package to bring sunscreen in line with other OTC drugs; a notification on the front label for consumers to read the skin cancer/skin aging alert for sunscreens that have not been shown to help prevent skin cancer; and revised formats for SPF, broad spectrum, and water resistance statements,” the statement said.
- Products that combine sunscreens with insect repellents are not GRASE.
In the meantime, though, consumers should continue to use sunscreens regularly as part of a comprehensive sun protection program, FDA Commissioner Scott Gottlieb, MD, said during the briefing. “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays,” he continued. “Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreens in conjunction with other sun protective measures (such as protective clothing) as this important rule-making effort moves forward.”
To submit comments on this proposed rule, go to https://www.regulations.gov and follow instructions for submitting comments.