Aesthetic Dermatology

DENVER – The fractionated picosecond Nd:YAG laser and fractionated thulium fiber laser can be equally effective for facial rejuvenation, results from a small split-face trial showed. However, the fractionated picosecond Nd:YAG laser may result in significantly less postoperative downtime, compared with the fractionated thulium fiber laser.

The findings from the prospective, evaluator-blinded trial were presented by Douglas C. Wu, MD, PhD, at the annual conference of the American Society for Laser Medicine and Surgery. Dr. Wu, of San Diego–based Cosmetic Laser Dermatology, and his colleague, Mitchel P. Goldman, MD, enrolled 20 subjects with at least moderate photoaging who randomly received three treatments with either the 1064/532-nm fractionated picosecond Nd:YAG laser or with the 1927-nm fractionated thulium fiber laser on each side of the face, 4 weeks apart. The primary endpoint was the degree of rhytids, laxity, dyschromia, erythema-telangiectasia, keratoses, and texture rated on a four-point scale and performed by a blinded evaluator at baseline, and 12, 20, and 30 weeks from baseline. Secondary endpoints were the global aesthetic improvement score, investigator satisfaction questionnaire, and a subject satisfaction questionnaire administered at weeks 12, 20, and 30. Recovery time and adverse events were assessed through a 14-day subject diary administered after each treatment.


All but 1 of the 20 patients were female and their mean age was 57 years. Six had Fitzpatrick skin type II, seven had type III, six had type IV, and one had type V. The device settings were on medium for both devices. The researchers observed significant improvements in elastosis, erythema, dyschromia, and texture at all treatment follow-up time points (P less than .01 for all endpoints).

There were no differences between the two lasers in terms of efficacy. “Clinically, the efficacy was rated to be the same,” Dr. Wu said. “However, when we analyzed the patient diaries, we found some very interesting results. In terms of redness, at days 3 and 4, there was a consistently increased amount of redness on the side treated with the fractionated thulium fiber laser, with swelling also being significantly increased at day 5.” Similarly, he said, the side treated with the fractionated picosecond laser experienced significantly less crusting on posttreatment days 1 through 9, less peeling on days 3 through 5, and less itching on day 4. Posttreatment pain was minimal on both sides and did not differ significantly.

Dr. Wu disclosed having numerous financial ties to pharmaceutical and device companies.

[email protected]

DENVER – The fractionated picosecond Nd:YAG laser and fractionated thulium fiber laser can be equally effective for facial rejuvenation, results from a small split-face trial showed. However, the fractionated picosecond Nd:YAG laser may result in significantly less postoperative downtime, compared with the fractionated thulium fiber laser.

The findings from the prospective, evaluator-blinded trial were presented by Douglas C. Wu, MD, PhD, at the annual conference of the American Society for Laser Medicine and Surgery. Dr. Wu, of San Diego–based Cosmetic Laser Dermatology, and his colleague, Mitchel P. Goldman, MD, enrolled 20 subjects with at least moderate photoaging who randomly received three treatments with either the 1064/532-nm fractionated picosecond Nd:YAG laser or with the 1927-nm fractionated thulium fiber laser on each side of the face, 4 weeks apart. The primary endpoint was the degree of rhytids, laxity, dyschromia, erythema-telangiectasia, keratoses, and texture rated on a four-point scale and performed by a blinded evaluator at baseline, and 12, 20, and 30 weeks from baseline. Secondary endpoints were the global aesthetic improvement score, investigator satisfaction questionnaire, and a subject satisfaction questionnaire administered at weeks 12, 20, and 30. Recovery time and adverse events were assessed through a 14-day subject diary administered after each treatment.


All but 1 of the 20 patients were female and their mean age was 57 years. Six had Fitzpatrick skin type II, seven had type III, six had type IV, and one had type V. The device settings were on medium for both devices. The researchers observed significant improvements in elastosis, erythema, dyschromia, and texture at all treatment follow-up time points (P less than .01 for all endpoints).

There were no differences between the two lasers in terms of efficacy. “Clinically, the efficacy was rated to be the same,” Dr. Wu said. “However, when we analyzed the patient diaries, we found some very interesting results. In terms of redness, at days 3 and 4, there was a consistently increased amount of redness on the side treated with the fractionated thulium fiber laser, with swelling also being significantly increased at day 5.” Similarly, he said, the side treated with the fractionated picosecond laser experienced significantly less crusting on posttreatment days 1 through 9, less peeling on days 3 through 5, and less itching on day 4. Posttreatment pain was minimal on both sides and did not differ significantly.

Dr. Wu disclosed having numerous financial ties to pharmaceutical and device companies.

[email protected]

DENVER – The fractionated picosecond Nd:YAG laser and fractionated thulium fiber laser can be equally effective for facial rejuvenation, results from a small split-face trial showed. However, the fractionated picosecond Nd:YAG laser may result in significantly less postoperative downtime, compared with the fractionated thulium fiber laser.

The findings from the prospective, evaluator-blinded trial were presented by Douglas C. Wu, MD, PhD, at the annual conference of the American Society for Laser Medicine and Surgery. Dr. Wu, of San Diego–based Cosmetic Laser Dermatology, and his colleague, Mitchel P. Goldman, MD, enrolled 20 subjects with at least moderate photoaging who randomly received three treatments with either the 1064/532-nm fractionated picosecond Nd:YAG laser or with the 1927-nm fractionated thulium fiber laser on each side of the face, 4 weeks apart. The primary endpoint was the degree of rhytids, laxity, dyschromia, erythema-telangiectasia, keratoses, and texture rated on a four-point scale and performed by a blinded evaluator at baseline, and 12, 20, and 30 weeks from baseline. Secondary endpoints were the global aesthetic improvement score, investigator satisfaction questionnaire, and a subject satisfaction questionnaire administered at weeks 12, 20, and 30. Recovery time and adverse events were assessed through a 14-day subject diary administered after each treatment.


All but 1 of the 20 patients were female and their mean age was 57 years. Six had Fitzpatrick skin type II, seven had type III, six had type IV, and one had type V. The device settings were on medium for both devices. The researchers observed significant improvements in elastosis, erythema, dyschromia, and texture at all treatment follow-up time points (P less than .01 for all endpoints).

There were no differences between the two lasers in terms of efficacy. “Clinically, the efficacy was rated to be the same,” Dr. Wu said. “However, when we analyzed the patient diaries, we found some very interesting results. In terms of redness, at days 3 and 4, there was a consistently increased amount of redness on the side treated with the fractionated thulium fiber laser, with swelling also being significantly increased at day 5.” Similarly, he said, the side treated with the fractionated picosecond laser experienced significantly less crusting on posttreatment days 1 through 9, less peeling on days 3 through 5, and less itching on day 4. Posttreatment pain was minimal on both sides and did not differ significantly.

Dr. Wu disclosed having numerous financial ties to pharmaceutical and device companies.

[email protected]

The use of nitrous oxide in dermatology and dermatologic surgery is becoming more common. When used properly, with meticulous patient monitoring, it is safe and effective. In my practice, I have used it for procedures as simple as a skin biopsy. While we have excellent topical numbing options for pain control, nitrous oxide works well as an anxiolytic and can help calm the patient who is nervous or has a fear of needles.

Nitrous oxide is a tasteless gas synthesized and released by cells. Inhalational nitrous oxide is absorbed from the lungs and diffuses into plasma, where it acts on the central nervous system as an anxiolytic and analgesic by blocking the NMDA receptor. It has a quick onset of action and short duration, is easily titrated, and has a low side effect profile.

Initially used to provide pain relief during labor in the late 1800s, nitrous oxide is now rarely used in the United States as inhalational analgesia during surgery or labor; however, use in dentistry and pediatrics is common. In a recent review of PubMed and Cochrane databases by Brotzman et al., eight studies on the use of nitrous oxide in dermatology were identified. Studies reported favorable safety and efficacy of nitrous oxide in providing analgesia during dermatologic procedures, which included facial rejuvenation, hair transplantation, and pediatric procedures. Several other studies also discussed the use of nitrous oxide in combination with tumescent anesthesia for venous ablation and liposuction. All adverse effects were limited to the time of inhalation and included euphoria, laughter, nausea, dizziness, and vertigo. There are no studies reviewing the risk of nitrous oxide used during CO₂ resurfacing procedures.

In five of the eight studies, vital signs and oxygen saturation were recorded during the period of inhalation. Almost all patients maintained adequate oxygen saturation and vitals also remained stable in these five studies, except for a slight increase in systolic and diastolic arterial pressure after ulcer debridement. In four of the eight studies, a 50% nitrous oxide/50% oxygen mixture delivered through an on-demand valve activated by a patient’s inspired breaths was used to minimize the risk of oversedation and to prevent hypoxia.

Contraindications for using nitrous oxide are pregnancy (in patients, health care providers, and assistants). Relative contraindications include nasal obstruction, chronic obstructive pulmonary disease, active cystic fibrosis, recent tympanic membrane surgery, and claustrophobia. According to the National Institute for Occupational Safety and Health, occupational exposure to nitrous oxide can lead to adverse effects that include reduced fertility and spontaneous abortion, as well as neurologic, renal, and hepatic diseases. The consensus of the majority of the studies in the PubMed/Cochrane review is that nitrous oxide provided a significant reduction in pain during dermatologic procedures, with mild and transient adverse effects. The effects dissipated quickly and thus patients could drive themselves home. But studies remain limited, and more well designed, randomized clinical trials are needed to provide clinical guidelines, safety monitoring protocols, and evidence for the use of nitrous oxide in dermatology. In my opinion, when more data are available, it will become one of the mainstays of analgesia in dermatologic procedures, particularly for pediatric, Mohs, and facial rejuvenation procedures.
 

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

Sources

Brotzman EA et al. Dermatol Surg. 2018 May;44(5):661-9.

“Controlling Exposures to Nitrous Oxide During Anesthetic Administration,” National Institute for Occupational Safety and Health (https://www.cdc.gov/niosh/docs/94-100/default.html).
 

The use of nitrous oxide in dermatology and dermatologic surgery is becoming more common. When used properly, with meticulous patient monitoring, it is safe and effective. In my practice, I have used it for procedures as simple as a skin biopsy. While we have excellent topical numbing options for pain control, nitrous oxide works well as an anxiolytic and can help calm the patient who is nervous or has a fear of needles.

Nitrous oxide is a tasteless gas synthesized and released by cells. Inhalational nitrous oxide is absorbed from the lungs and diffuses into plasma, where it acts on the central nervous system as an anxiolytic and analgesic by blocking the NMDA receptor. It has a quick onset of action and short duration, is easily titrated, and has a low side effect profile.

Initially used to provide pain relief during labor in the late 1800s, nitrous oxide is now rarely used in the United States as inhalational analgesia during surgery or labor; however, use in dentistry and pediatrics is common. In a recent review of PubMed and Cochrane databases by Brotzman et al., eight studies on the use of nitrous oxide in dermatology were identified. Studies reported favorable safety and efficacy of nitrous oxide in providing analgesia during dermatologic procedures, which included facial rejuvenation, hair transplantation, and pediatric procedures. Several other studies also discussed the use of nitrous oxide in combination with tumescent anesthesia for venous ablation and liposuction. All adverse effects were limited to the time of inhalation and included euphoria, laughter, nausea, dizziness, and vertigo. There are no studies reviewing the risk of nitrous oxide used during CO₂ resurfacing procedures.

In five of the eight studies, vital signs and oxygen saturation were recorded during the period of inhalation. Almost all patients maintained adequate oxygen saturation and vitals also remained stable in these five studies, except for a slight increase in systolic and diastolic arterial pressure after ulcer debridement. In four of the eight studies, a 50% nitrous oxide/50% oxygen mixture delivered through an on-demand valve activated by a patient’s inspired breaths was used to minimize the risk of oversedation and to prevent hypoxia.

Contraindications for using nitrous oxide are pregnancy (in patients, health care providers, and assistants). Relative contraindications include nasal obstruction, chronic obstructive pulmonary disease, active cystic fibrosis, recent tympanic membrane surgery, and claustrophobia. According to the National Institute for Occupational Safety and Health, occupational exposure to nitrous oxide can lead to adverse effects that include reduced fertility and spontaneous abortion, as well as neurologic, renal, and hepatic diseases. The consensus of the majority of the studies in the PubMed/Cochrane review is that nitrous oxide provided a significant reduction in pain during dermatologic procedures, with mild and transient adverse effects. The effects dissipated quickly and thus patients could drive themselves home. But studies remain limited, and more well designed, randomized clinical trials are needed to provide clinical guidelines, safety monitoring protocols, and evidence for the use of nitrous oxide in dermatology. In my opinion, when more data are available, it will become one of the mainstays of analgesia in dermatologic procedures, particularly for pediatric, Mohs, and facial rejuvenation procedures.
 

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

Sources

Brotzman EA et al. Dermatol Surg. 2018 May;44(5):661-9.

“Controlling Exposures to Nitrous Oxide During Anesthetic Administration,” National Institute for Occupational Safety and Health (https://www.cdc.gov/niosh/docs/94-100/default.html).
 

The use of nitrous oxide in dermatology and dermatologic surgery is becoming more common. When used properly, with meticulous patient monitoring, it is safe and effective. In my practice, I have used it for procedures as simple as a skin biopsy. While we have excellent topical numbing options for pain control, nitrous oxide works well as an anxiolytic and can help calm the patient who is nervous or has a fear of needles.

Nitrous oxide is a tasteless gas synthesized and released by cells. Inhalational nitrous oxide is absorbed from the lungs and diffuses into plasma, where it acts on the central nervous system as an anxiolytic and analgesic by blocking the NMDA receptor. It has a quick onset of action and short duration, is easily titrated, and has a low side effect profile.

Initially used to provide pain relief during labor in the late 1800s, nitrous oxide is now rarely used in the United States as inhalational analgesia during surgery or labor; however, use in dentistry and pediatrics is common. In a recent review of PubMed and Cochrane databases by Brotzman et al., eight studies on the use of nitrous oxide in dermatology were identified. Studies reported favorable safety and efficacy of nitrous oxide in providing analgesia during dermatologic procedures, which included facial rejuvenation, hair transplantation, and pediatric procedures. Several other studies also discussed the use of nitrous oxide in combination with tumescent anesthesia for venous ablation and liposuction. All adverse effects were limited to the time of inhalation and included euphoria, laughter, nausea, dizziness, and vertigo. There are no studies reviewing the risk of nitrous oxide used during CO₂ resurfacing procedures.

In five of the eight studies, vital signs and oxygen saturation were recorded during the period of inhalation. Almost all patients maintained adequate oxygen saturation and vitals also remained stable in these five studies, except for a slight increase in systolic and diastolic arterial pressure after ulcer debridement. In four of the eight studies, a 50% nitrous oxide/50% oxygen mixture delivered through an on-demand valve activated by a patient’s inspired breaths was used to minimize the risk of oversedation and to prevent hypoxia.

Contraindications for using nitrous oxide are pregnancy (in patients, health care providers, and assistants). Relative contraindications include nasal obstruction, chronic obstructive pulmonary disease, active cystic fibrosis, recent tympanic membrane surgery, and claustrophobia. According to the National Institute for Occupational Safety and Health, occupational exposure to nitrous oxide can lead to adverse effects that include reduced fertility and spontaneous abortion, as well as neurologic, renal, and hepatic diseases. The consensus of the majority of the studies in the PubMed/Cochrane review is that nitrous oxide provided a significant reduction in pain during dermatologic procedures, with mild and transient adverse effects. The effects dissipated quickly and thus patients could drive themselves home. But studies remain limited, and more well designed, randomized clinical trials are needed to provide clinical guidelines, safety monitoring protocols, and evidence for the use of nitrous oxide in dermatology. In my opinion, when more data are available, it will become one of the mainstays of analgesia in dermatologic procedures, particularly for pediatric, Mohs, and facial rejuvenation procedures.
 

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

Sources

Brotzman EA et al. Dermatol Surg. 2018 May;44(5):661-9.

“Controlling Exposures to Nitrous Oxide During Anesthetic Administration,” National Institute for Occupational Safety and Health (https://www.cdc.gov/niosh/docs/94-100/default.html).
 

DENVER – A device that provides electromagnetic stimulation to muscles is being investigated as a way to complement noninvasive body contouring.

The device, known as CoolTone, is being developed by Allergan and uses high-powered coil electromagnetic stimulation applicators to induce eddy currents in the muscle tissue. CoolTone is pending Food and Drug Administration clearance and is not yet commercially available.

“Fat reduction is just one part of body contouring,” Mathew M. Avram, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “You have skin, fat, and muscle. More and more we’re targeting all three areas for patients’ best body contouring outcomes.”

According to Dr. Avram, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston, CoolTone provides high-frequency electromagnetic muscle stimulation that triggers muscle contractions that cannot be achieved by normal exercise to increase muscle mass and strength. “You’re doing super physiological amounts of contractions with this stimulation – the equivalent of doing thousands of sit-ups, if you’re treating the abdomen,” he said. “It strengthens, tones, and firms muscles in abdomen, buttocks, arms, and legs. There is a history of this type of technology for athletes and other indications in physical therapy.”

The current FDA clearance for a predicate electromagnetic stimulation system for muscle conditioning is for the abdomen, buttocks, thighs, and arms. “This is for improvement of abdominal tone, strengthening of the abdominal muscles, and development of a firmer abdomen,” said Dr. Avram, who also is director of dermatologic surgery at Mass General. “It’s for strengthening, toning, and firming of buttocks and thighs, and for improvement of muscle tone and firmness, and for strengthening muscle in arms.”

The electrical current induced by the CoolTone device flows readily into muscle and not into fat, he continued. This brings the current to nearby motor nerve structures that stimulate contraction once the action potential is reached. “You’re getting maximal contractions that are extreme for a full range of muscle fibers,” explained Dr. Avram, who is the immediate past president of the ASLMS. “This requires an external electrical stimulus; it’s not something you do with normal exercise. With mild exercise, only the slow-twitch muscle fibers are activated, not the fast-twitch muscle fibers. Also, the pulsing sequences are designed to preferentially excite motor nerves rather than sensory nerves. So it’s really going after the ability for you to contract your muscles as much as possible.”

Dr. Avram has received consulting fees from Merz and Alastin and holds ownership interests with ZALEA, InMode, and Cytrellis. He has served on the advisory boards for ZELTIQ Aesthetics, Soliton, Sciton, and Sienna Biopharmaceuticals, and he has intellectual property rights with Cytrellis.

[email protected]

DENVER – A device that provides electromagnetic stimulation to muscles is being investigated as a way to complement noninvasive body contouring.

The device, known as CoolTone, is being developed by Allergan and uses high-powered coil electromagnetic stimulation applicators to induce eddy currents in the muscle tissue. CoolTone is pending Food and Drug Administration clearance and is not yet commercially available.

“Fat reduction is just one part of body contouring,” Mathew M. Avram, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “You have skin, fat, and muscle. More and more we’re targeting all three areas for patients’ best body contouring outcomes.”

According to Dr. Avram, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston, CoolTone provides high-frequency electromagnetic muscle stimulation that triggers muscle contractions that cannot be achieved by normal exercise to increase muscle mass and strength. “You’re doing super physiological amounts of contractions with this stimulation – the equivalent of doing thousands of sit-ups, if you’re treating the abdomen,” he said. “It strengthens, tones, and firms muscles in abdomen, buttocks, arms, and legs. There is a history of this type of technology for athletes and other indications in physical therapy.”

The current FDA clearance for a predicate electromagnetic stimulation system for muscle conditioning is for the abdomen, buttocks, thighs, and arms. “This is for improvement of abdominal tone, strengthening of the abdominal muscles, and development of a firmer abdomen,” said Dr. Avram, who also is director of dermatologic surgery at Mass General. “It’s for strengthening, toning, and firming of buttocks and thighs, and for improvement of muscle tone and firmness, and for strengthening muscle in arms.”

The electrical current induced by the CoolTone device flows readily into muscle and not into fat, he continued. This brings the current to nearby motor nerve structures that stimulate contraction once the action potential is reached. “You’re getting maximal contractions that are extreme for a full range of muscle fibers,” explained Dr. Avram, who is the immediate past president of the ASLMS. “This requires an external electrical stimulus; it’s not something you do with normal exercise. With mild exercise, only the slow-twitch muscle fibers are activated, not the fast-twitch muscle fibers. Also, the pulsing sequences are designed to preferentially excite motor nerves rather than sensory nerves. So it’s really going after the ability for you to contract your muscles as much as possible.”

Dr. Avram has received consulting fees from Merz and Alastin and holds ownership interests with ZALEA, InMode, and Cytrellis. He has served on the advisory boards for ZELTIQ Aesthetics, Soliton, Sciton, and Sienna Biopharmaceuticals, and he has intellectual property rights with Cytrellis.

[email protected]

DENVER – A device that provides electromagnetic stimulation to muscles is being investigated as a way to complement noninvasive body contouring.

The device, known as CoolTone, is being developed by Allergan and uses high-powered coil electromagnetic stimulation applicators to induce eddy currents in the muscle tissue. CoolTone is pending Food and Drug Administration clearance and is not yet commercially available.

“Fat reduction is just one part of body contouring,” Mathew M. Avram, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “You have skin, fat, and muscle. More and more we’re targeting all three areas for patients’ best body contouring outcomes.”

According to Dr. Avram, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston, CoolTone provides high-frequency electromagnetic muscle stimulation that triggers muscle contractions that cannot be achieved by normal exercise to increase muscle mass and strength. “You’re doing super physiological amounts of contractions with this stimulation – the equivalent of doing thousands of sit-ups, if you’re treating the abdomen,” he said. “It strengthens, tones, and firms muscles in abdomen, buttocks, arms, and legs. There is a history of this type of technology for athletes and other indications in physical therapy.”

The current FDA clearance for a predicate electromagnetic stimulation system for muscle conditioning is for the abdomen, buttocks, thighs, and arms. “This is for improvement of abdominal tone, strengthening of the abdominal muscles, and development of a firmer abdomen,” said Dr. Avram, who also is director of dermatologic surgery at Mass General. “It’s for strengthening, toning, and firming of buttocks and thighs, and for improvement of muscle tone and firmness, and for strengthening muscle in arms.”

The electrical current induced by the CoolTone device flows readily into muscle and not into fat, he continued. This brings the current to nearby motor nerve structures that stimulate contraction once the action potential is reached. “You’re getting maximal contractions that are extreme for a full range of muscle fibers,” explained Dr. Avram, who is the immediate past president of the ASLMS. “This requires an external electrical stimulus; it’s not something you do with normal exercise. With mild exercise, only the slow-twitch muscle fibers are activated, not the fast-twitch muscle fibers. Also, the pulsing sequences are designed to preferentially excite motor nerves rather than sensory nerves. So it’s really going after the ability for you to contract your muscles as much as possible.”

Dr. Avram has received consulting fees from Merz and Alastin and holds ownership interests with ZALEA, InMode, and Cytrellis. He has served on the advisory boards for ZELTIQ Aesthetics, Soliton, Sciton, and Sienna Biopharmaceuticals, and he has intellectual property rights with Cytrellis.

[email protected]

DENVER – A survey from a dermatology practice in Houston found that among patients seeking corrective treatment for laser tattoo removal, 79% had complications from previous removal attempts and 63% were treated in non-clinic facilities by a non-physician provider without physician supervision.

The findings come from a single-center study that sought to identify the type, burden, and frequency of complications from laser tattoo removal, a procedure offered by both physician and non-physician facilities. “Laser tattoo removal is increasing in popularity,” lead study author Amanda K. Suggs, MD, said at the annual conference of the American Society for Laser Medicine and Surgery.

Dr. Suggs and Paul M. Friedman, MD, of Houston-based Dermatology and Laser Surgery, have observed an increase in patients seeking corrective tattoo removal after complications from and lack of efficacy of prior treatments provided predominantly at non-clinic facilities, including medical spas and tattoo removal clinics –so they decided to interview 19 patients who presented to their practice seeking corrective laser tattoo removal. The majority (84%) were female, their mean age was 34 years old, and 53% had Fitzpatrick skin types IV or higher. Nearly three-quarters of tattoos (74%) consisted of multiple colors, which are known to be more difficult to treat. Of the patients seeking corrective treatment, 42% were seeking removal of more than one tattoo.

Prior to coming to their office, the patients had undergone an average of seven prior tattoo removal treatments and 72% of patients were treated by a non-physician provider at some point. Nearly two-thirds of patients (63%) were treated in non-clinic facilities. “All patients were unsatisfied with the degree of improvement, and 79% had at least one complication from their prior treatments,” said Dr. Suggs, who is a fellow at the practice.

Of the 15 patients with prior treatment complications, 64% were treated by a non-physician provider. The most common complication was scarring (53%), followed by dyspigmentation (47%), blistering (20%) and paradoxical darkening (20%). Six patients (40%) had more than one complication. Patients with Fitzpatrick skin types IV or higher had a higher proportion of scarring and dyspigmentation (63% and 71%, respectively) compared with those with other skin types. “This suggests that we should use caution when treating tattoos in patients with higher Fitzpatrick skin types, and use appropriate settings and endpoints when treating these patients,” Dr. Suggs said.


When she and Dr. Friedman interviewed the patients about their prior treatment experience elsewhere, all said they experienced excessive pain, only 33% received topical anesthesia, and none reported receiving an injectable anesthesia.

At the Dermatology and Laser Surgery Center, the protocol for corrective laser tattoo removal involves injectable anesthesia, Dr. Suggs said. They use a picosecond laser, a perfluorodecalin patch, and, if needed, nonablative fractional resurfacing at 1550 nm for scarring. The wavelength used for the picosecond laser (1064nm, 785nm or 532nm) is chosen based on patient characteristics and tattoo color or colors.

Lance Sitton Photography/Thinkstock

In a subset analysis, the investigators interviewed eight patients again after undergoing laser tattoo removal at their practice. All underwent treatment with a picosecond laser, perfluorodecalin patch, and injectable anesthesia. All reported minimal to no pain during the procedure and an optimal experience. No complications were noted.

Dr. Friedman and Dr. Suggs emphasized that consumers should be aware of the risks and potential for complications from laser tattoo removal. They recommend that all consumers – especially those at higher risk for complications such as higher Fitzpatrick skin type patients and those with multicolored tattoos – choose a provider with extensive training in the procedure, such as a board-certified dermatologist or plastic surgeon.

Dr. Suggs disclosed that she is an ambassador for Tri Sirena sun protective athletic apparel. Dr. Friedman disclosed that he is a member of the advisory board for Allergan, Solta Medical, Syneron-Candela, and Sienna Biopharmaceuticals. He is also a research investigator for Syneron-Candela and has received a research grant from Sienna.

[email protected]

DENVER – A survey from a dermatology practice in Houston found that among patients seeking corrective treatment for laser tattoo removal, 79% had complications from previous removal attempts and 63% were treated in non-clinic facilities by a non-physician provider without physician supervision.

The findings come from a single-center study that sought to identify the type, burden, and frequency of complications from laser tattoo removal, a procedure offered by both physician and non-physician facilities. “Laser tattoo removal is increasing in popularity,” lead study author Amanda K. Suggs, MD, said at the annual conference of the American Society for Laser Medicine and Surgery.

Dr. Suggs and Paul M. Friedman, MD, of Houston-based Dermatology and Laser Surgery, have observed an increase in patients seeking corrective tattoo removal after complications from and lack of efficacy of prior treatments provided predominantly at non-clinic facilities, including medical spas and tattoo removal clinics –so they decided to interview 19 patients who presented to their practice seeking corrective laser tattoo removal. The majority (84%) were female, their mean age was 34 years old, and 53% had Fitzpatrick skin types IV or higher. Nearly three-quarters of tattoos (74%) consisted of multiple colors, which are known to be more difficult to treat. Of the patients seeking corrective treatment, 42% were seeking removal of more than one tattoo.

Prior to coming to their office, the patients had undergone an average of seven prior tattoo removal treatments and 72% of patients were treated by a non-physician provider at some point. Nearly two-thirds of patients (63%) were treated in non-clinic facilities. “All patients were unsatisfied with the degree of improvement, and 79% had at least one complication from their prior treatments,” said Dr. Suggs, who is a fellow at the practice.

Of the 15 patients with prior treatment complications, 64% were treated by a non-physician provider. The most common complication was scarring (53%), followed by dyspigmentation (47%), blistering (20%) and paradoxical darkening (20%). Six patients (40%) had more than one complication. Patients with Fitzpatrick skin types IV or higher had a higher proportion of scarring and dyspigmentation (63% and 71%, respectively) compared with those with other skin types. “This suggests that we should use caution when treating tattoos in patients with higher Fitzpatrick skin types, and use appropriate settings and endpoints when treating these patients,” Dr. Suggs said.


When she and Dr. Friedman interviewed the patients about their prior treatment experience elsewhere, all said they experienced excessive pain, only 33% received topical anesthesia, and none reported receiving an injectable anesthesia.

At the Dermatology and Laser Surgery Center, the protocol for corrective laser tattoo removal involves injectable anesthesia, Dr. Suggs said. They use a picosecond laser, a perfluorodecalin patch, and, if needed, nonablative fractional resurfacing at 1550 nm for scarring. The wavelength used for the picosecond laser (1064nm, 785nm or 532nm) is chosen based on patient characteristics and tattoo color or colors.

Lance Sitton Photography/Thinkstock

In a subset analysis, the investigators interviewed eight patients again after undergoing laser tattoo removal at their practice. All underwent treatment with a picosecond laser, perfluorodecalin patch, and injectable anesthesia. All reported minimal to no pain during the procedure and an optimal experience. No complications were noted.

Dr. Friedman and Dr. Suggs emphasized that consumers should be aware of the risks and potential for complications from laser tattoo removal. They recommend that all consumers – especially those at higher risk for complications such as higher Fitzpatrick skin type patients and those with multicolored tattoos – choose a provider with extensive training in the procedure, such as a board-certified dermatologist or plastic surgeon.

Dr. Suggs disclosed that she is an ambassador for Tri Sirena sun protective athletic apparel. Dr. Friedman disclosed that he is a member of the advisory board for Allergan, Solta Medical, Syneron-Candela, and Sienna Biopharmaceuticals. He is also a research investigator for Syneron-Candela and has received a research grant from Sienna.

[email protected]

DENVER – A survey from a dermatology practice in Houston found that among patients seeking corrective treatment for laser tattoo removal, 79% had complications from previous removal attempts and 63% were treated in non-clinic facilities by a non-physician provider without physician supervision.

The findings come from a single-center study that sought to identify the type, burden, and frequency of complications from laser tattoo removal, a procedure offered by both physician and non-physician facilities. “Laser tattoo removal is increasing in popularity,” lead study author Amanda K. Suggs, MD, said at the annual conference of the American Society for Laser Medicine and Surgery.

Dr. Suggs and Paul M. Friedman, MD, of Houston-based Dermatology and Laser Surgery, have observed an increase in patients seeking corrective tattoo removal after complications from and lack of efficacy of prior treatments provided predominantly at non-clinic facilities, including medical spas and tattoo removal clinics –so they decided to interview 19 patients who presented to their practice seeking corrective laser tattoo removal. The majority (84%) were female, their mean age was 34 years old, and 53% had Fitzpatrick skin types IV or higher. Nearly three-quarters of tattoos (74%) consisted of multiple colors, which are known to be more difficult to treat. Of the patients seeking corrective treatment, 42% were seeking removal of more than one tattoo.

Prior to coming to their office, the patients had undergone an average of seven prior tattoo removal treatments and 72% of patients were treated by a non-physician provider at some point. Nearly two-thirds of patients (63%) were treated in non-clinic facilities. “All patients were unsatisfied with the degree of improvement, and 79% had at least one complication from their prior treatments,” said Dr. Suggs, who is a fellow at the practice.

Of the 15 patients with prior treatment complications, 64% were treated by a non-physician provider. The most common complication was scarring (53%), followed by dyspigmentation (47%), blistering (20%) and paradoxical darkening (20%). Six patients (40%) had more than one complication. Patients with Fitzpatrick skin types IV or higher had a higher proportion of scarring and dyspigmentation (63% and 71%, respectively) compared with those with other skin types. “This suggests that we should use caution when treating tattoos in patients with higher Fitzpatrick skin types, and use appropriate settings and endpoints when treating these patients,” Dr. Suggs said.


When she and Dr. Friedman interviewed the patients about their prior treatment experience elsewhere, all said they experienced excessive pain, only 33% received topical anesthesia, and none reported receiving an injectable anesthesia.

At the Dermatology and Laser Surgery Center, the protocol for corrective laser tattoo removal involves injectable anesthesia, Dr. Suggs said. They use a picosecond laser, a perfluorodecalin patch, and, if needed, nonablative fractional resurfacing at 1550 nm for scarring. The wavelength used for the picosecond laser (1064nm, 785nm or 532nm) is chosen based on patient characteristics and tattoo color or colors.

Lance Sitton Photography/Thinkstock

In a subset analysis, the investigators interviewed eight patients again after undergoing laser tattoo removal at their practice. All underwent treatment with a picosecond laser, perfluorodecalin patch, and injectable anesthesia. All reported minimal to no pain during the procedure and an optimal experience. No complications were noted.

Dr. Friedman and Dr. Suggs emphasized that consumers should be aware of the risks and potential for complications from laser tattoo removal. They recommend that all consumers – especially those at higher risk for complications such as higher Fitzpatrick skin type patients and those with multicolored tattoos – choose a provider with extensive training in the procedure, such as a board-certified dermatologist or plastic surgeon.

Dr. Suggs disclosed that she is an ambassador for Tri Sirena sun protective athletic apparel. Dr. Friedman disclosed that he is a member of the advisory board for Allergan, Solta Medical, Syneron-Candela, and Sienna Biopharmaceuticals. He is also a research investigator for Syneron-Candela and has received a research grant from Sienna.

[email protected]

Lactobionic acid (4-O-beta-galactopyranosyl-D-gluconic acid), a disaccharide formed from gluconic acid and galactose, has been established as a potent antioxidant well suited for use in solutions intended to preserve organs stored for transplantation.^1,2 This polyhydroxy bionic acid is used as an excipient agent in some pharmaceutical products and has been the object of increasing interest and use in cosmetics and cosmeceuticals.³ It is included in skin care formulations for its strong humectant and antiaging effects.^3,4 Lactobionic acid has been shown to suppress the synthesis of hydroxyl radicals by dint of iron-chelating activity and hinders the production of matrix metalloproteinases (MMPs), which promote photoaging.^2,3,5 It may also present an advantage over the class of alpha-hydroxy acids used to treat photoaging by engendering less or no irritation, because of its larger molecular size and corresponding slower penetration rate.⁶ This column will focus on some recent research on the application of this strong antioxidant in dermatologic practice.

Lactobionic acid as an ingredient and vehicle

In 2010, Tasic-Kostov et al. compared the efficacy and irritation potential of lactobionic and glycolic acids (in gel and emulsion vehicles). In 77 healthy volunteers, the investigators found that formulations containing lactobionic acid yielded better skin metrics than ones containing glycolic acid, insofar as the former caused no irritation or skin barrier damage. In a second part to the study, they determined that efficacy of the acids was improved through the use of vehicles based on the natural emulsifier, alkyl polyglucoside (APG). They concluded that lactobionic acid in a 6% concentration in an APG vehicle warranted consideration as a low-molecular option in cosmeceutical products.⁶

In a subsequent study, the same team found supportive evidence that APG-based emulsions are safe cosmetic/dermopharmaceutical vehicles and carriers for extremely acidic and hygroscopic AHAs, particularly lactobionic acid. They did note, however, that lactobionic acid markedly affected the colloidal structure of the emulsion and fostered the development of lamellar structures, which could influence water distribution within the cream. They concluded, therefore, that such an emulsion, which was stabilized by lamellar liquid crystalline structures, would not be a viable carrier for the hygroscopic actives to achieve optimal moisturizing potential.⁷More recently, Tasic-Kostov et al. investigated the antioxidant and moisturizing traits of lactobionic acid in solution as well as in a natural APG emulsifier–based system using 1,1-diphenyl-2-picrylhydrazyl free radical scavenging and lipid peroxidation inhibition assays. The researchers found that lactobionic acid exhibited suitable physical stability (though it exerted notable impact on the colloidal structure of the vehicle) as well as antioxidant activity in both formats, suggesting its application as a versatile cosmeceutical agent for treating photoaged skin.²

In 2017, Chaouat et al. found that lactobionic acid was a key component in a green microparticle carrier system for cosmetics also containing chitosan and linoleic acid (as the skin penetration–enhancing constituent). Chitosan and lactobionic acid made up the shell surrounding the linoleic acid core. The carrier system, in an aqueous solution, was found to be stable and able to encapsulate the hydrophobic skin lightener phenylethyl resorcinol.⁸

Potential in atopic dermatitis treatment

Using an oxazolone-induced, atopic dermatitis–like murine dermatitis model, Sakai et al. demonstrated in 2016 that the coapplication of a PAR2 inhibitor and lactobionic acid, which maintained stratum corneum acidity, could target skin barrier abnormality and allergic inflammation, the key mechanisms in atopic dermatitis etiology.⁹

Lactobionic acid in chemical peels

Early this year, Algiert-Zielinska et al. reported on the results of a split-face study with 20 white women in which the effects of a 20% lactobionic acid peel were compared with those of the 20% peel combined with aluminum oxide crystal microdermabrasion. Treatments were administered weekly over 6 weeks, with the peel alone performed on the left side and the combination therapy on the right. The combination was found to achieve a significantly higher hydration level as well as skin elasticity measurements. There were no statistically significant differences between the tested therapies in transepidermal water loss, which decreased for both approaches. Both the lactobionic acid peel and combination procedure delivered notable moisturizing effects.¹⁰

Previously, this team performed a comparative evaluation of the skin-moisturizing activities of lactobionic acid in 10% and 30% concentrations in 10 white subjects between 26 and 73 years old. In this split-face study, 10% lactobionic acid was applied on the left side and 30% on the right on a weekly basis through eight treatments. A 5% lactobionic acid cream was supplied for overnight use. Skin hydration levels were measured before each weekly treatment. Although any differences between cutaneous hydration between the lactobionic acid preparations could not be ascertained, the investigators identified a statistically significant enhancement of hydration levels for both concentrations after the full series of treatments. They concluded that lactobionic is a potent moisturizing compound.¹¹The same authors also conducted a literature review on the moisturizing properties of lactobionic and lactic acids, noting that both acids are capable of binding copious amounts of water and display robust chelating characteristics, as well as antioxidant activity, by suppressing MMPs. The authors added that both act as strong moisturizing substances, helping to maintain epidermal barrier integrity, and are suitable for sensitive skin.³

Conclusion

Greater capacity to moisturize and deliver antiaging benefits while causing less or no irritation are desirable qualities in a dermatologic agent. Evidence is limited, but the data available seem to suggest that lactobionic acid exhibits such qualities in comparison to alpha-hydroxy acids. Much more research is needed, though, to determine the most appropriate ways to use this promising compound.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].

References

1. Annu Rev Med. 1995;46:235-47.

2. Int J Cosmet Sci. 2012 Oct;34(5):424-34.

3. Int J Dermatol. 2019 Mar;58(3):374-79.

4. Clin Dermatol. 2009 Sep-Oct;27(5):495-501.

5.The next generation hydroxy acids, in “Cosmeceuticals” (New York: Elsevier Saunders, 2005, pp. 205-11).

6. J Cosmet Dermatol. 2010 Mar;9(1):3-10.

7. Pharmazie. 2011 Nov;66(11):862-70.

8. J Microencapsul. 2017 Mar;34(2):162-70.

9. J Invest Dermatol. 2016 Feb;136(2):538-41.

10. J Cosmet Dermatol. 2019 Jan 20. doi: 10.1111/jocd.12859. [Epub ahead of print].

11. J Cosmet Dermatol. 2018 Dec;17(6):1096-1100.

Lactobionic acid (4-O-beta-galactopyranosyl-D-gluconic acid), a disaccharide formed from gluconic acid and galactose, has been established as a potent antioxidant well suited for use in solutions intended to preserve organs stored for transplantation.^1,2 This polyhydroxy bionic acid is used as an excipient agent in some pharmaceutical products and has been the object of increasing interest and use in cosmetics and cosmeceuticals.³ It is included in skin care formulations for its strong humectant and antiaging effects.^3,4 Lactobionic acid has been shown to suppress the synthesis of hydroxyl radicals by dint of iron-chelating activity and hinders the production of matrix metalloproteinases (MMPs), which promote photoaging.^2,3,5 It may also present an advantage over the class of alpha-hydroxy acids used to treat photoaging by engendering less or no irritation, because of its larger molecular size and corresponding slower penetration rate.⁶ This column will focus on some recent research on the application of this strong antioxidant in dermatologic practice.

Lactobionic acid as an ingredient and vehicle

In 2010, Tasic-Kostov et al. compared the efficacy and irritation potential of lactobionic and glycolic acids (in gel and emulsion vehicles). In 77 healthy volunteers, the investigators found that formulations containing lactobionic acid yielded better skin metrics than ones containing glycolic acid, insofar as the former caused no irritation or skin barrier damage. In a second part to the study, they determined that efficacy of the acids was improved through the use of vehicles based on the natural emulsifier, alkyl polyglucoside (APG). They concluded that lactobionic acid in a 6% concentration in an APG vehicle warranted consideration as a low-molecular option in cosmeceutical products.⁶

In a subsequent study, the same team found supportive evidence that APG-based emulsions are safe cosmetic/dermopharmaceutical vehicles and carriers for extremely acidic and hygroscopic AHAs, particularly lactobionic acid. They did note, however, that lactobionic acid markedly affected the colloidal structure of the emulsion and fostered the development of lamellar structures, which could influence water distribution within the cream. They concluded, therefore, that such an emulsion, which was stabilized by lamellar liquid crystalline structures, would not be a viable carrier for the hygroscopic actives to achieve optimal moisturizing potential.⁷More recently, Tasic-Kostov et al. investigated the antioxidant and moisturizing traits of lactobionic acid in solution as well as in a natural APG emulsifier–based system using 1,1-diphenyl-2-picrylhydrazyl free radical scavenging and lipid peroxidation inhibition assays. The researchers found that lactobionic acid exhibited suitable physical stability (though it exerted notable impact on the colloidal structure of the vehicle) as well as antioxidant activity in both formats, suggesting its application as a versatile cosmeceutical agent for treating photoaged skin.²

In 2017, Chaouat et al. found that lactobionic acid was a key component in a green microparticle carrier system for cosmetics also containing chitosan and linoleic acid (as the skin penetration–enhancing constituent). Chitosan and lactobionic acid made up the shell surrounding the linoleic acid core. The carrier system, in an aqueous solution, was found to be stable and able to encapsulate the hydrophobic skin lightener phenylethyl resorcinol.⁸

Potential in atopic dermatitis treatment

Using an oxazolone-induced, atopic dermatitis–like murine dermatitis model, Sakai et al. demonstrated in 2016 that the coapplication of a PAR2 inhibitor and lactobionic acid, which maintained stratum corneum acidity, could target skin barrier abnormality and allergic inflammation, the key mechanisms in atopic dermatitis etiology.⁹

Lactobionic acid in chemical peels

Early this year, Algiert-Zielinska et al. reported on the results of a split-face study with 20 white women in which the effects of a 20% lactobionic acid peel were compared with those of the 20% peel combined with aluminum oxide crystal microdermabrasion. Treatments were administered weekly over 6 weeks, with the peel alone performed on the left side and the combination therapy on the right. The combination was found to achieve a significantly higher hydration level as well as skin elasticity measurements. There were no statistically significant differences between the tested therapies in transepidermal water loss, which decreased for both approaches. Both the lactobionic acid peel and combination procedure delivered notable moisturizing effects.¹⁰

Previously, this team performed a comparative evaluation of the skin-moisturizing activities of lactobionic acid in 10% and 30% concentrations in 10 white subjects between 26 and 73 years old. In this split-face study, 10% lactobionic acid was applied on the left side and 30% on the right on a weekly basis through eight treatments. A 5% lactobionic acid cream was supplied for overnight use. Skin hydration levels were measured before each weekly treatment. Although any differences between cutaneous hydration between the lactobionic acid preparations could not be ascertained, the investigators identified a statistically significant enhancement of hydration levels for both concentrations after the full series of treatments. They concluded that lactobionic is a potent moisturizing compound.¹¹The same authors also conducted a literature review on the moisturizing properties of lactobionic and lactic acids, noting that both acids are capable of binding copious amounts of water and display robust chelating characteristics, as well as antioxidant activity, by suppressing MMPs. The authors added that both act as strong moisturizing substances, helping to maintain epidermal barrier integrity, and are suitable for sensitive skin.³

Conclusion

Greater capacity to moisturize and deliver antiaging benefits while causing less or no irritation are desirable qualities in a dermatologic agent. Evidence is limited, but the data available seem to suggest that lactobionic acid exhibits such qualities in comparison to alpha-hydroxy acids. Much more research is needed, though, to determine the most appropriate ways to use this promising compound.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].

References

1. Annu Rev Med. 1995;46:235-47.

2. Int J Cosmet Sci. 2012 Oct;34(5):424-34.

3. Int J Dermatol. 2019 Mar;58(3):374-79.

4. Clin Dermatol. 2009 Sep-Oct;27(5):495-501.

5.The next generation hydroxy acids, in “Cosmeceuticals” (New York: Elsevier Saunders, 2005, pp. 205-11).

6. J Cosmet Dermatol. 2010 Mar;9(1):3-10.

7. Pharmazie. 2011 Nov;66(11):862-70.

8. J Microencapsul. 2017 Mar;34(2):162-70.

9. J Invest Dermatol. 2016 Feb;136(2):538-41.

10. J Cosmet Dermatol. 2019 Jan 20. doi: 10.1111/jocd.12859. [Epub ahead of print].

11. J Cosmet Dermatol. 2018 Dec;17(6):1096-1100.

Lactobionic acid (4-O-beta-galactopyranosyl-D-gluconic acid), a disaccharide formed from gluconic acid and galactose, has been established as a potent antioxidant well suited for use in solutions intended to preserve organs stored for transplantation.^1,2 This polyhydroxy bionic acid is used as an excipient agent in some pharmaceutical products and has been the object of increasing interest and use in cosmetics and cosmeceuticals.³ It is included in skin care formulations for its strong humectant and antiaging effects.^3,4 Lactobionic acid has been shown to suppress the synthesis of hydroxyl radicals by dint of iron-chelating activity and hinders the production of matrix metalloproteinases (MMPs), which promote photoaging.^2,3,5 It may also present an advantage over the class of alpha-hydroxy acids used to treat photoaging by engendering less or no irritation, because of its larger molecular size and corresponding slower penetration rate.⁶ This column will focus on some recent research on the application of this strong antioxidant in dermatologic practice.

Lactobionic acid as an ingredient and vehicle

In 2010, Tasic-Kostov et al. compared the efficacy and irritation potential of lactobionic and glycolic acids (in gel and emulsion vehicles). In 77 healthy volunteers, the investigators found that formulations containing lactobionic acid yielded better skin metrics than ones containing glycolic acid, insofar as the former caused no irritation or skin barrier damage. In a second part to the study, they determined that efficacy of the acids was improved through the use of vehicles based on the natural emulsifier, alkyl polyglucoside (APG). They concluded that lactobionic acid in a 6% concentration in an APG vehicle warranted consideration as a low-molecular option in cosmeceutical products.⁶

In a subsequent study, the same team found supportive evidence that APG-based emulsions are safe cosmetic/dermopharmaceutical vehicles and carriers for extremely acidic and hygroscopic AHAs, particularly lactobionic acid. They did note, however, that lactobionic acid markedly affected the colloidal structure of the emulsion and fostered the development of lamellar structures, which could influence water distribution within the cream. They concluded, therefore, that such an emulsion, which was stabilized by lamellar liquid crystalline structures, would not be a viable carrier for the hygroscopic actives to achieve optimal moisturizing potential.⁷More recently, Tasic-Kostov et al. investigated the antioxidant and moisturizing traits of lactobionic acid in solution as well as in a natural APG emulsifier–based system using 1,1-diphenyl-2-picrylhydrazyl free radical scavenging and lipid peroxidation inhibition assays. The researchers found that lactobionic acid exhibited suitable physical stability (though it exerted notable impact on the colloidal structure of the vehicle) as well as antioxidant activity in both formats, suggesting its application as a versatile cosmeceutical agent for treating photoaged skin.²

In 2017, Chaouat et al. found that lactobionic acid was a key component in a green microparticle carrier system for cosmetics also containing chitosan and linoleic acid (as the skin penetration–enhancing constituent). Chitosan and lactobionic acid made up the shell surrounding the linoleic acid core. The carrier system, in an aqueous solution, was found to be stable and able to encapsulate the hydrophobic skin lightener phenylethyl resorcinol.⁸

Potential in atopic dermatitis treatment

Using an oxazolone-induced, atopic dermatitis–like murine dermatitis model, Sakai et al. demonstrated in 2016 that the coapplication of a PAR2 inhibitor and lactobionic acid, which maintained stratum corneum acidity, could target skin barrier abnormality and allergic inflammation, the key mechanisms in atopic dermatitis etiology.⁹

Lactobionic acid in chemical peels

Early this year, Algiert-Zielinska et al. reported on the results of a split-face study with 20 white women in which the effects of a 20% lactobionic acid peel were compared with those of the 20% peel combined with aluminum oxide crystal microdermabrasion. Treatments were administered weekly over 6 weeks, with the peel alone performed on the left side and the combination therapy on the right. The combination was found to achieve a significantly higher hydration level as well as skin elasticity measurements. There were no statistically significant differences between the tested therapies in transepidermal water loss, which decreased for both approaches. Both the lactobionic acid peel and combination procedure delivered notable moisturizing effects.¹⁰

Previously, this team performed a comparative evaluation of the skin-moisturizing activities of lactobionic acid in 10% and 30% concentrations in 10 white subjects between 26 and 73 years old. In this split-face study, 10% lactobionic acid was applied on the left side and 30% on the right on a weekly basis through eight treatments. A 5% lactobionic acid cream was supplied for overnight use. Skin hydration levels were measured before each weekly treatment. Although any differences between cutaneous hydration between the lactobionic acid preparations could not be ascertained, the investigators identified a statistically significant enhancement of hydration levels for both concentrations after the full series of treatments. They concluded that lactobionic is a potent moisturizing compound.¹¹The same authors also conducted a literature review on the moisturizing properties of lactobionic and lactic acids, noting that both acids are capable of binding copious amounts of water and display robust chelating characteristics, as well as antioxidant activity, by suppressing MMPs. The authors added that both act as strong moisturizing substances, helping to maintain epidermal barrier integrity, and are suitable for sensitive skin.³

Conclusion

Greater capacity to moisturize and deliver antiaging benefits while causing less or no irritation are desirable qualities in a dermatologic agent. Evidence is limited, but the data available seem to suggest that lactobionic acid exhibits such qualities in comparison to alpha-hydroxy acids. Much more research is needed, though, to determine the most appropriate ways to use this promising compound.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and “Cosmeceuticals and Cosmetic Ingredients” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].

References

1. Annu Rev Med. 1995;46:235-47.

2. Int J Cosmet Sci. 2012 Oct;34(5):424-34.

3. Int J Dermatol. 2019 Mar;58(3):374-79.

4. Clin Dermatol. 2009 Sep-Oct;27(5):495-501.

5.The next generation hydroxy acids, in “Cosmeceuticals” (New York: Elsevier Saunders, 2005, pp. 205-11).

6. J Cosmet Dermatol. 2010 Mar;9(1):3-10.

7. Pharmazie. 2011 Nov;66(11):862-70.

8. J Microencapsul. 2017 Mar;34(2):162-70.

9. J Invest Dermatol. 2016 Feb;136(2):538-41.

10. J Cosmet Dermatol. 2019 Jan 20. doi: 10.1111/jocd.12859. [Epub ahead of print].

11. J Cosmet Dermatol. 2018 Dec;17(6):1096-1100.

DENVER – Patients treated with a new device that delivered high magnetic energy with a 3-cm spot size experienced an overall improvement in lower face and neck skin laxity, results from a small trial showed.

“There are many different modalities for tissue tightening, including lights, radiofrequency, ultrasound and thermal energy,” Jerome M. Garden, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “The idea behind all of these technologies is to heat up the skin’s collagen and to stimulate further collagen production, which can then result in improved skin tightening and textural improvement.”

In a trial conducted at the Chicago-based Physicians Laser and Dermatology Institute, Dr. Garden and his colleagues evaluated a new technology for tissue tightening that involves magnetic energy. Developed by Rocky Mountain Biosystems and BioFusionary Corp., the investigative device produces a magnetic field in the targeted tissue, which then results in the heating and eventual tightening of the tissue. “By using magnetic energy, which relies on the polarity of the molecules, it allows for a safe way to target specifically the polar dermis, without heating the relatively dry epidermis or nonpolar adipose layer, resulting in a more tolerable and potentially safer alternative to tissue tightening,” said Dr. Garden, a dermatologist who is the director of the Physicians Laser and Dermatology Institute.

For the trial, 20 patients with facial and upper skin laxity underwent a mean of 4.3 treatment sessions with the 27MHz magnetic device that used a 3-cm spot size, with a minimum of 4 weeks between each session. No anesthetics or analgesics were used. “No gels or skin prep was performed before the treatment, other than a gentle soap beforehand,” Dr. Garden said. “A bland moisturizer was applied to the treated skin after treatments.” The majority of patients (85%) had paid for their procedures (a price comparable to other skin-tightening procedures), and two board-certified dermatologists evaluated both before and after photographs for overall improvement of skin laxity and texture. Follow-ups were done 2-4 months after the last treatment. The observers were not informed which photographs were before or after.

Dr. Garden reported that the observers correctly chose 19 out of 20 patients’ before and after photographs, and they rated the mean grade level of improvement as 43%. Nearly half of the patients (48%) were graded at 50% or greater improvement. At the same time, patients rated their own improvement as a mean 6.5 out of 10. Nearly half of patients graded their outcome at 7 or better, which was designated as “very satisfied.” The procedures were well tolerated, Dr. Garden said, and the most common side effects were minor transient erythema and edema. The erythema generally faded after 2-4 hours, and the mild edema lasted up to 24 hours.

“Magnetic energy is a new technology that can be used to treat lower face and neck laxity,” said Dr. Garden, who is also a professor of clinical dermatology at Northwestern University, Chicago. “We only treated patients with skin types I-IV, but we feel that this technology is likely safe for higher skin types as well.”

Rocky Mountain Biosystems and BioFusionary Corp. provided the device used for the study. Dr. Garden and his colleagues are currently extending the ongoing trial. He reported having no financial disclosures.

[email protected]

DENVER – Patients treated with a new device that delivered high magnetic energy with a 3-cm spot size experienced an overall improvement in lower face and neck skin laxity, results from a small trial showed.

“There are many different modalities for tissue tightening, including lights, radiofrequency, ultrasound and thermal energy,” Jerome M. Garden, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “The idea behind all of these technologies is to heat up the skin’s collagen and to stimulate further collagen production, which can then result in improved skin tightening and textural improvement.”

In a trial conducted at the Chicago-based Physicians Laser and Dermatology Institute, Dr. Garden and his colleagues evaluated a new technology for tissue tightening that involves magnetic energy. Developed by Rocky Mountain Biosystems and BioFusionary Corp., the investigative device produces a magnetic field in the targeted tissue, which then results in the heating and eventual tightening of the tissue. “By using magnetic energy, which relies on the polarity of the molecules, it allows for a safe way to target specifically the polar dermis, without heating the relatively dry epidermis or nonpolar adipose layer, resulting in a more tolerable and potentially safer alternative to tissue tightening,” said Dr. Garden, a dermatologist who is the director of the Physicians Laser and Dermatology Institute.

For the trial, 20 patients with facial and upper skin laxity underwent a mean of 4.3 treatment sessions with the 27MHz magnetic device that used a 3-cm spot size, with a minimum of 4 weeks between each session. No anesthetics or analgesics were used. “No gels or skin prep was performed before the treatment, other than a gentle soap beforehand,” Dr. Garden said. “A bland moisturizer was applied to the treated skin after treatments.” The majority of patients (85%) had paid for their procedures (a price comparable to other skin-tightening procedures), and two board-certified dermatologists evaluated both before and after photographs for overall improvement of skin laxity and texture. Follow-ups were done 2-4 months after the last treatment. The observers were not informed which photographs were before or after.

Dr. Garden reported that the observers correctly chose 19 out of 20 patients’ before and after photographs, and they rated the mean grade level of improvement as 43%. Nearly half of the patients (48%) were graded at 50% or greater improvement. At the same time, patients rated their own improvement as a mean 6.5 out of 10. Nearly half of patients graded their outcome at 7 or better, which was designated as “very satisfied.” The procedures were well tolerated, Dr. Garden said, and the most common side effects were minor transient erythema and edema. The erythema generally faded after 2-4 hours, and the mild edema lasted up to 24 hours.

“Magnetic energy is a new technology that can be used to treat lower face and neck laxity,” said Dr. Garden, who is also a professor of clinical dermatology at Northwestern University, Chicago. “We only treated patients with skin types I-IV, but we feel that this technology is likely safe for higher skin types as well.”

Rocky Mountain Biosystems and BioFusionary Corp. provided the device used for the study. Dr. Garden and his colleagues are currently extending the ongoing trial. He reported having no financial disclosures.

[email protected]

DENVER – Patients treated with a new device that delivered high magnetic energy with a 3-cm spot size experienced an overall improvement in lower face and neck skin laxity, results from a small trial showed.

“There are many different modalities for tissue tightening, including lights, radiofrequency, ultrasound and thermal energy,” Jerome M. Garden, MD, said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery. “The idea behind all of these technologies is to heat up the skin’s collagen and to stimulate further collagen production, which can then result in improved skin tightening and textural improvement.”

In a trial conducted at the Chicago-based Physicians Laser and Dermatology Institute, Dr. Garden and his colleagues evaluated a new technology for tissue tightening that involves magnetic energy. Developed by Rocky Mountain Biosystems and BioFusionary Corp., the investigative device produces a magnetic field in the targeted tissue, which then results in the heating and eventual tightening of the tissue. “By using magnetic energy, which relies on the polarity of the molecules, it allows for a safe way to target specifically the polar dermis, without heating the relatively dry epidermis or nonpolar adipose layer, resulting in a more tolerable and potentially safer alternative to tissue tightening,” said Dr. Garden, a dermatologist who is the director of the Physicians Laser and Dermatology Institute.

For the trial, 20 patients with facial and upper skin laxity underwent a mean of 4.3 treatment sessions with the 27MHz magnetic device that used a 3-cm spot size, with a minimum of 4 weeks between each session. No anesthetics or analgesics were used. “No gels or skin prep was performed before the treatment, other than a gentle soap beforehand,” Dr. Garden said. “A bland moisturizer was applied to the treated skin after treatments.” The majority of patients (85%) had paid for their procedures (a price comparable to other skin-tightening procedures), and two board-certified dermatologists evaluated both before and after photographs for overall improvement of skin laxity and texture. Follow-ups were done 2-4 months after the last treatment. The observers were not informed which photographs were before or after.

Dr. Garden reported that the observers correctly chose 19 out of 20 patients’ before and after photographs, and they rated the mean grade level of improvement as 43%. Nearly half of the patients (48%) were graded at 50% or greater improvement. At the same time, patients rated their own improvement as a mean 6.5 out of 10. Nearly half of patients graded their outcome at 7 or better, which was designated as “very satisfied.” The procedures were well tolerated, Dr. Garden said, and the most common side effects were minor transient erythema and edema. The erythema generally faded after 2-4 hours, and the mild edema lasted up to 24 hours.

“Magnetic energy is a new technology that can be used to treat lower face and neck laxity,” said Dr. Garden, who is also a professor of clinical dermatology at Northwestern University, Chicago. “We only treated patients with skin types I-IV, but we feel that this technology is likely safe for higher skin types as well.”

Rocky Mountain Biosystems and BioFusionary Corp. provided the device used for the study. Dr. Garden and his colleagues are currently extending the ongoing trial. He reported having no financial disclosures.

[email protected]

WASHINGTON – At the annual meeting of the American Academy of Dermatology, the current and past presidents of the American Society for Laser Medicine and Surgery (ASLMS) sat down to discuss the Society’s annual meeting, taking place March 27-31, 2019, in Denver.

Vidyard Video

“ASLMS is always an amazing meeting, and it’s a unique meeting,” said past president Mathew Avram, MD, director of the Dermatology Laser & Cosmetic Center at Massachusetts General Hospital, Boston. “At its core, it’s a scientific meeting ... you can take things back to your practice that change the practice of medicine.”

Current ASLMS president Eric Bernstein, MD, of Main Line Center for Laser Surgery, Ardmore, Pa., pointed out that, in addition to doctors and other health care practitioners, other available and accessible attendees include the engineers who build the lasers. And this year, injectables are being incorporated into the program.

MDedge reporter Doug Brunk will be reporting from the meeting.

WASHINGTON – At the annual meeting of the American Academy of Dermatology, the current and past presidents of the American Society for Laser Medicine and Surgery (ASLMS) sat down to discuss the Society’s annual meeting, taking place March 27-31, 2019, in Denver.

Vidyard Video

“ASLMS is always an amazing meeting, and it’s a unique meeting,” said past president Mathew Avram, MD, director of the Dermatology Laser & Cosmetic Center at Massachusetts General Hospital, Boston. “At its core, it’s a scientific meeting ... you can take things back to your practice that change the practice of medicine.”

Current ASLMS president Eric Bernstein, MD, of Main Line Center for Laser Surgery, Ardmore, Pa., pointed out that, in addition to doctors and other health care practitioners, other available and accessible attendees include the engineers who build the lasers. And this year, injectables are being incorporated into the program.

MDedge reporter Doug Brunk will be reporting from the meeting.

WASHINGTON – At the annual meeting of the American Academy of Dermatology, the current and past presidents of the American Society for Laser Medicine and Surgery (ASLMS) sat down to discuss the Society’s annual meeting, taking place March 27-31, 2019, in Denver.

Vidyard Video

“ASLMS is always an amazing meeting, and it’s a unique meeting,” said past president Mathew Avram, MD, director of the Dermatology Laser & Cosmetic Center at Massachusetts General Hospital, Boston. “At its core, it’s a scientific meeting ... you can take things back to your practice that change the practice of medicine.”

Current ASLMS president Eric Bernstein, MD, of Main Line Center for Laser Surgery, Ardmore, Pa., pointed out that, in addition to doctors and other health care practitioners, other available and accessible attendees include the engineers who build the lasers. And this year, injectables are being incorporated into the program.

MDedge reporter Doug Brunk will be reporting from the meeting.

Patients with textured silicone gluteal implants could be at risk of anaplastic large cell lymphoma, based on a possible case of ALCL in a patient diagnosed 1 year after implant placement.

The 49-year-old woman was initially diagnosed with anaplastic lymphoma kinase–negative ALCL via a lung mass and pleural fluid before bilateral gluteal ulceration occurred 1 month later, reported Orr Shauly of the University of Southern California in Los Angeles, and his colleagues.

Soft-tissue disease and fluid accumulation around the gluteal implants suggested that the lung mass had metastasized from primary neoplasia in the gluteal region. If ALCL did originate at the site of the gluteal implants, it would represent a first for silicone implant–associated ALCL, which has historically been associated exclusively with breast implants.

“As many as 200 cases of [breast implant-associated ALCL] have been described worldwide, with a majority in the context of cosmetic primary breast augmentation or cancer-related breast reconstruction with the use of a textured implant (57% of all cases),” the investigators wrote in Aesthetic Surgery Journal. “Recently however, it has been hypothesized that the relationship of ALCL with the placement of textured silicone implants may not [be] limited to the breast due to its multifactorial nature and association with texturization of the implant surface.”

During the initial work-up, a CT showed fluid collection and enhancement around the gluteal implants. Following ALCL diagnosis via lung mass biopsy and histopathology, the patient was transferred to a different facility for chemotherapy. When the patient presented 1 month later to the original facility with gluteal ulceration, the oncology team suspected infection; however, all cultures from fluid around the implants were negative.

Because of the possibility of false-negative tests, the patient was started on a regimen of acyclovir, vancomycin, metronidazole, and isavuconazole. Explantation was planned, but before this could occur, the patient deteriorated rapidly and died of respiratory and renal failure.

ALCL was not confirmed via cytology or histopathology in the gluteal region, and the patient’s family did not consent to autopsy, so a definitive diagnosis of gluteal implant–associated ALCL remained elusive.

“In this instance, it can only be concluded that the patient’s condition may have been associated with placement of textured silicone gluteal implants, but [we] still lack evidence of causation,” the investigators wrote. “It should also be noted that ALCL does not typically present with skin ulceration, and this may be a unique disease process in this patient or as a result of her bedridden state given the late stage of her disease. Furthermore, this presentation was uniquely aggressive and presented extremely quickly after placement of the gluteal implants. In most patients, ALCL develops and presents approximately 10 years after implantation.”

The investigators cautioned that “care should be taken to avoid sensationalizing all implant-associated ALCL.”

The authors reported having no conflicts of interest and the study did not receive funding.

SOURCE: Shauly O et al. Aesthet Surg J. 2019 Feb 15. doi: 10.1093/asj/sjz044.

Patients with textured silicone gluteal implants could be at risk of anaplastic large cell lymphoma, based on a possible case of ALCL in a patient diagnosed 1 year after implant placement.

The 49-year-old woman was initially diagnosed with anaplastic lymphoma kinase–negative ALCL via a lung mass and pleural fluid before bilateral gluteal ulceration occurred 1 month later, reported Orr Shauly of the University of Southern California in Los Angeles, and his colleagues.

Soft-tissue disease and fluid accumulation around the gluteal implants suggested that the lung mass had metastasized from primary neoplasia in the gluteal region. If ALCL did originate at the site of the gluteal implants, it would represent a first for silicone implant–associated ALCL, which has historically been associated exclusively with breast implants.

“As many as 200 cases of [breast implant-associated ALCL] have been described worldwide, with a majority in the context of cosmetic primary breast augmentation or cancer-related breast reconstruction with the use of a textured implant (57% of all cases),” the investigators wrote in Aesthetic Surgery Journal. “Recently however, it has been hypothesized that the relationship of ALCL with the placement of textured silicone implants may not [be] limited to the breast due to its multifactorial nature and association with texturization of the implant surface.”

During the initial work-up, a CT showed fluid collection and enhancement around the gluteal implants. Following ALCL diagnosis via lung mass biopsy and histopathology, the patient was transferred to a different facility for chemotherapy. When the patient presented 1 month later to the original facility with gluteal ulceration, the oncology team suspected infection; however, all cultures from fluid around the implants were negative.

Because of the possibility of false-negative tests, the patient was started on a regimen of acyclovir, vancomycin, metronidazole, and isavuconazole. Explantation was planned, but before this could occur, the patient deteriorated rapidly and died of respiratory and renal failure.

ALCL was not confirmed via cytology or histopathology in the gluteal region, and the patient’s family did not consent to autopsy, so a definitive diagnosis of gluteal implant–associated ALCL remained elusive.

“In this instance, it can only be concluded that the patient’s condition may have been associated with placement of textured silicone gluteal implants, but [we] still lack evidence of causation,” the investigators wrote. “It should also be noted that ALCL does not typically present with skin ulceration, and this may be a unique disease process in this patient or as a result of her bedridden state given the late stage of her disease. Furthermore, this presentation was uniquely aggressive and presented extremely quickly after placement of the gluteal implants. In most patients, ALCL develops and presents approximately 10 years after implantation.”

The investigators cautioned that “care should be taken to avoid sensationalizing all implant-associated ALCL.”

The authors reported having no conflicts of interest and the study did not receive funding.

SOURCE: Shauly O et al. Aesthet Surg J. 2019 Feb 15. doi: 10.1093/asj/sjz044.

Patients with textured silicone gluteal implants could be at risk of anaplastic large cell lymphoma, based on a possible case of ALCL in a patient diagnosed 1 year after implant placement.

The 49-year-old woman was initially diagnosed with anaplastic lymphoma kinase–negative ALCL via a lung mass and pleural fluid before bilateral gluteal ulceration occurred 1 month later, reported Orr Shauly of the University of Southern California in Los Angeles, and his colleagues.

Soft-tissue disease and fluid accumulation around the gluteal implants suggested that the lung mass had metastasized from primary neoplasia in the gluteal region. If ALCL did originate at the site of the gluteal implants, it would represent a first for silicone implant–associated ALCL, which has historically been associated exclusively with breast implants.

“As many as 200 cases of [breast implant-associated ALCL] have been described worldwide, with a majority in the context of cosmetic primary breast augmentation or cancer-related breast reconstruction with the use of a textured implant (57% of all cases),” the investigators wrote in Aesthetic Surgery Journal. “Recently however, it has been hypothesized that the relationship of ALCL with the placement of textured silicone implants may not [be] limited to the breast due to its multifactorial nature and association with texturization of the implant surface.”

During the initial work-up, a CT showed fluid collection and enhancement around the gluteal implants. Following ALCL diagnosis via lung mass biopsy and histopathology, the patient was transferred to a different facility for chemotherapy. When the patient presented 1 month later to the original facility with gluteal ulceration, the oncology team suspected infection; however, all cultures from fluid around the implants were negative.

Because of the possibility of false-negative tests, the patient was started on a regimen of acyclovir, vancomycin, metronidazole, and isavuconazole. Explantation was planned, but before this could occur, the patient deteriorated rapidly and died of respiratory and renal failure.

ALCL was not confirmed via cytology or histopathology in the gluteal region, and the patient’s family did not consent to autopsy, so a definitive diagnosis of gluteal implant–associated ALCL remained elusive.

“In this instance, it can only be concluded that the patient’s condition may have been associated with placement of textured silicone gluteal implants, but [we] still lack evidence of causation,” the investigators wrote. “It should also be noted that ALCL does not typically present with skin ulceration, and this may be a unique disease process in this patient or as a result of her bedridden state given the late stage of her disease. Furthermore, this presentation was uniquely aggressive and presented extremely quickly after placement of the gluteal implants. In most patients, ALCL develops and presents approximately 10 years after implantation.”

The investigators cautioned that “care should be taken to avoid sensationalizing all implant-associated ALCL.”

The authors reported having no conflicts of interest and the study did not receive funding.

SOURCE: Shauly O et al. Aesthet Surg J. 2019 Feb 15. doi: 10.1093/asj/sjz044.

Recall that melatonin displays multiple biological functions, acting as an antioxidant, cytokine, neurotransmitter, and global regulator of the circadian clock, the latter for which it is best known.^1-3 At the cutaneous level, melatonin exhibits antioxidant (direct, as a radical scavenger; indirect, through upregulating antioxidant enzymes), anti-inflammatory, photoprotective, tissue regenerative, and cytoprotective activity, particularly in its capacity to preserve mitochondrial function.^4-8

Melatonin also protects skin homeostasis,⁶ and, consequently, is believed to act against carcinogenesis and potentially other deleterious dysfunctions such as hyperproliferative/inflammatory conditions.⁵ Notably, functional melatonin receptors are expressed in human skin and hair follicles, where melatonin is also produced, further buttressing the critical role that melatonin plays in skin health.⁵ Melatonin also displays immunomodulatory, thermoregulatory, and antitumor functions.⁹ The topical application of melatonin has been demonstrated to diminish markers of reactive oxygen species as well as reverse manifestations of cutaneous aging.⁵

Melatonin is both produced by and metabolized in the skin. The hormone and its metabolites (6-hydroxymelatonin, N¹-acetyl-N²-formyl-5-methoxykynuramine [AFMK], N-acetyl-serotonin, and 5-methoxytryptamine) reduce UVB-induced oxidative cell damage in human keratinocytes and melanocytes, and also act as radioprotectors.⁶

Melatonin has been shown to protect human dermal fibroblasts from UVA- and UVB-induced damage.⁹ In addition, melatonin and its metabolites have been demonstrated to suppress the growth of cultured human melanomas, and high doses of melatonin used in clinical trials in late metastatic melanoma stages have enhanced the efficacy of or diminished the side effects of chemotherapy/chemo-immunotherapy.⁹

UVB and melatonin in the lab

In a 2018 hairless mouse study in which animals were irradiated by UVB for 8 weeks, Park et al. showed that melatonin displays anti-wrinkle activity by suppressing reactive oxygen species- and sonic hedgehog-mediated inflammatory proteins. Melatonin also protected against transepidermal water loss and prevented epidermal thickness as well as dermal collagen degradation.¹⁰

Also that year, Skobowiat et al. found that the topical application of melatonin and its active derivatives (N1-acetyl-N2-formyl-5-methoxykynurenine and N-acetylserotonin) yielded photoprotective effects pre- and post-UVB treatment in human and porcine skin ex vivo. They concluded that their results justify additional investigation of the clinical applications of melatonin and its metabolites for its potential to exert protective effects against UVB in human subjects.⁸

Although the preponderance of previous work identifies melatonin as a strong antioxidant, Kocyigit et al. reported in 2018 on new in vitro studies suggesting that melatonin dose-dependently exerts cytotoxic and apoptotic activity on several cell types, including both human epidermoid carcinoma and normal skin fibroblasts. Their findings showed that melatonin exhibited proliferative effects on cancerous and normal cells at low doses and cytotoxic effects at high doses.¹¹
 

Melatonin as a sunscreen ingredient

Further supporting its use in the topical armamentarium for skin health, melatonin is a key ingredient in a sunscreen formulation, the creation of which was driven by the need to protect the skin of military personnel facing lengthy UV exposure. Specifically, the formulation containing avobenzone, octinoxate, oxybenzone, and titanium dioxide along with melatonin and pumpkin seed oil underwent a preclinical safety evaluation in 2017, as reported by Bora et al. The formulation was found to be nonmutagenic, nontoxic, and safe in animal models and is deemed ready to test for its efficacy in humans.¹² Melatonin is also among a host of systemic treatment options for skin lightening.¹³

Oral and topical melatonin in human studies

In a 2017 study on the impact of melatonin treatment on the skin of former smokers, Sagan et al. assessed oxidative damage to membrane lipids in blood serum and in epidermis exfoliated during microdermabrasion (at baseline, 2 weeks after, and 4 weeks after treatment) in postmenopausal women. Never smokers (n = 44) and former smokers (n = 46) were divided into control, melatonin topical, antioxidant topical, and melatonin oral treatment groups. The investigators found that after only 2 weeks, melatonin oral treatment significantly reversed the elevated serum lipid peroxidation in former smokers. Oral melatonin increased elasticity, moisture, and sebum levels after 4 weeks of treatment and topical melatonin increased sebum level. They concluded that the use of exogenous melatonin reverses the effects of oxidative damage to membrane lipids and ameliorates cutaneous biophysical traits in postmenopausal women who once smoked. The researchers added that melatonin use for all former smokers is warranted and that topically applied melatonin merits consideration for improving the effects of facial microdermabrasion.¹⁴

In a systematic literature review in 2017, Scheuer identified 20 studies (4 human and 16 experimental) indicating that melatonin exerts a protective effect against artificial UV-induced erythema when applied pre-exposure.⁷ Also that year, Scheuer and colleagues conducted randomized, double-blind, placebo-controlled work demonstrating that topical melatonin (12.5%) significantly reduced erythema resulting from natural sunlight, and in a separate randomized, double-blind, placebo-controlled crossover study that the same concentration of a full body application of melatonin exhibited no significant impact on cognition and should be considered safe for dermal application.⁷ Scheuer added that additional longitudinal research is needed to ascertain effects of topical melatonin usage over time.

Early in 2018, Milani and Sparavigna reported on a randomized, split-face, assessor-blinded, prospective 3-month study of 22 women (mean age 55 years) with moderate to severe facial skin aging; the study was designed to test the efficacy of melatonin-based day and night creams. All of the women completed the proof-of-concept trial in which crow’s feet were found to be significantly diminished on the sides of the face treated with the creams compared with the nontreated skin.

Image Source/getty images

Conclusion

The majority of research on the potent hormone melatonin over nearly the last quarter century indicates that this dynamic substance provides multifaceted benefits in performing several biological functions. Topical melatonin is available over the counter. Its expanded use in skin care warrants greater attention as we learn more about this versatile endogenous substance.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and “Cosmeceuticals and Cosmetic Ingredients,” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].

References

1. Zmijewski MA et al. Dermatoendocrinol. 2011 Jan;3(1):3-10.

2. Slominski A et al. Trends Endocrinol Metab. 2008 Jan;19(1):17-24.

3. Slominski A et al. J Cell Physiol. 2003 Jul;196(1):144-53.

4. Milani M et al. Clin Cosmet Investig Dermatol. 2018 Jan 24;11:51-7.

5. Day D et al. J Drugs Dermatol. 2018 Sep 1;17(9):966-9.

6. Slominski AT et al. Cell Mol Life Sci. 2017 Nov;74(21):3913-25.

7. Scheuer C. Dan Med J. 2017 Jun;64(6). pii:B5358.

8. Skobowiat C et al. J Pineal Res. 2018 Sep;65(2):e12501.

9. Slominski AT et al. J Invest Dermatol. 2018 Mar;138(3):490-9.

10. Park EK et al. Int J Mol Sci. 2018 Jul 8;19(7). pii: E1995.

11. Kocyigit A et al. Mutat Res. 2018 May-Jun;829-30:50-60.

12. Bora NS et al. Regul Toxicol Pharmacol. 2017 Oct;89:1-12.

13. Juhasz MLW et al. J Cosmet Dermatol. 2018 Dec;17(6):1144-57.

14. Sagan D et al. Ann Agric Environ Med. 2017 Dec 23;24(4):659-66.

Recall that melatonin displays multiple biological functions, acting as an antioxidant, cytokine, neurotransmitter, and global regulator of the circadian clock, the latter for which it is best known.^1-3 At the cutaneous level, melatonin exhibits antioxidant (direct, as a radical scavenger; indirect, through upregulating antioxidant enzymes), anti-inflammatory, photoprotective, tissue regenerative, and cytoprotective activity, particularly in its capacity to preserve mitochondrial function.^4-8

Melatonin also protects skin homeostasis,⁶ and, consequently, is believed to act against carcinogenesis and potentially other deleterious dysfunctions such as hyperproliferative/inflammatory conditions.⁵ Notably, functional melatonin receptors are expressed in human skin and hair follicles, where melatonin is also produced, further buttressing the critical role that melatonin plays in skin health.⁵ Melatonin also displays immunomodulatory, thermoregulatory, and antitumor functions.⁹ The topical application of melatonin has been demonstrated to diminish markers of reactive oxygen species as well as reverse manifestations of cutaneous aging.⁵

Melatonin is both produced by and metabolized in the skin. The hormone and its metabolites (6-hydroxymelatonin, N¹-acetyl-N²-formyl-5-methoxykynuramine [AFMK], N-acetyl-serotonin, and 5-methoxytryptamine) reduce UVB-induced oxidative cell damage in human keratinocytes and melanocytes, and also act as radioprotectors.⁶

Melatonin has been shown to protect human dermal fibroblasts from UVA- and UVB-induced damage.⁹ In addition, melatonin and its metabolites have been demonstrated to suppress the growth of cultured human melanomas, and high doses of melatonin used in clinical trials in late metastatic melanoma stages have enhanced the efficacy of or diminished the side effects of chemotherapy/chemo-immunotherapy.⁹

UVB and melatonin in the lab

In a 2018 hairless mouse study in which animals were irradiated by UVB for 8 weeks, Park et al. showed that melatonin displays anti-wrinkle activity by suppressing reactive oxygen species- and sonic hedgehog-mediated inflammatory proteins. Melatonin also protected against transepidermal water loss and prevented epidermal thickness as well as dermal collagen degradation.¹⁰

Also that year, Skobowiat et al. found that the topical application of melatonin and its active derivatives (N1-acetyl-N2-formyl-5-methoxykynurenine and N-acetylserotonin) yielded photoprotective effects pre- and post-UVB treatment in human and porcine skin ex vivo. They concluded that their results justify additional investigation of the clinical applications of melatonin and its metabolites for its potential to exert protective effects against UVB in human subjects.⁸

Although the preponderance of previous work identifies melatonin as a strong antioxidant, Kocyigit et al. reported in 2018 on new in vitro studies suggesting that melatonin dose-dependently exerts cytotoxic and apoptotic activity on several cell types, including both human epidermoid carcinoma and normal skin fibroblasts. Their findings showed that melatonin exhibited proliferative effects on cancerous and normal cells at low doses and cytotoxic effects at high doses.¹¹
 

Melatonin as a sunscreen ingredient

Further supporting its use in the topical armamentarium for skin health, melatonin is a key ingredient in a sunscreen formulation, the creation of which was driven by the need to protect the skin of military personnel facing lengthy UV exposure. Specifically, the formulation containing avobenzone, octinoxate, oxybenzone, and titanium dioxide along with melatonin and pumpkin seed oil underwent a preclinical safety evaluation in 2017, as reported by Bora et al. The formulation was found to be nonmutagenic, nontoxic, and safe in animal models and is deemed ready to test for its efficacy in humans.¹² Melatonin is also among a host of systemic treatment options for skin lightening.¹³

Oral and topical melatonin in human studies

In a 2017 study on the impact of melatonin treatment on the skin of former smokers, Sagan et al. assessed oxidative damage to membrane lipids in blood serum and in epidermis exfoliated during microdermabrasion (at baseline, 2 weeks after, and 4 weeks after treatment) in postmenopausal women. Never smokers (n = 44) and former smokers (n = 46) were divided into control, melatonin topical, antioxidant topical, and melatonin oral treatment groups. The investigators found that after only 2 weeks, melatonin oral treatment significantly reversed the elevated serum lipid peroxidation in former smokers. Oral melatonin increased elasticity, moisture, and sebum levels after 4 weeks of treatment and topical melatonin increased sebum level. They concluded that the use of exogenous melatonin reverses the effects of oxidative damage to membrane lipids and ameliorates cutaneous biophysical traits in postmenopausal women who once smoked. The researchers added that melatonin use for all former smokers is warranted and that topically applied melatonin merits consideration for improving the effects of facial microdermabrasion.¹⁴

In a systematic literature review in 2017, Scheuer identified 20 studies (4 human and 16 experimental) indicating that melatonin exerts a protective effect against artificial UV-induced erythema when applied pre-exposure.⁷ Also that year, Scheuer and colleagues conducted randomized, double-blind, placebo-controlled work demonstrating that topical melatonin (12.5%) significantly reduced erythema resulting from natural sunlight, and in a separate randomized, double-blind, placebo-controlled crossover study that the same concentration of a full body application of melatonin exhibited no significant impact on cognition and should be considered safe for dermal application.⁷ Scheuer added that additional longitudinal research is needed to ascertain effects of topical melatonin usage over time.

Early in 2018, Milani and Sparavigna reported on a randomized, split-face, assessor-blinded, prospective 3-month study of 22 women (mean age 55 years) with moderate to severe facial skin aging; the study was designed to test the efficacy of melatonin-based day and night creams. All of the women completed the proof-of-concept trial in which crow’s feet were found to be significantly diminished on the sides of the face treated with the creams compared with the nontreated skin.

Image Source/getty images

Conclusion

The majority of research on the potent hormone melatonin over nearly the last quarter century indicates that this dynamic substance provides multifaceted benefits in performing several biological functions. Topical melatonin is available over the counter. Its expanded use in skin care warrants greater attention as we learn more about this versatile endogenous substance.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and “Cosmeceuticals and Cosmetic Ingredients,” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].

References

1. Zmijewski MA et al. Dermatoendocrinol. 2011 Jan;3(1):3-10.

2. Slominski A et al. Trends Endocrinol Metab. 2008 Jan;19(1):17-24.

3. Slominski A et al. J Cell Physiol. 2003 Jul;196(1):144-53.

4. Milani M et al. Clin Cosmet Investig Dermatol. 2018 Jan 24;11:51-7.

5. Day D et al. J Drugs Dermatol. 2018 Sep 1;17(9):966-9.

6. Slominski AT et al. Cell Mol Life Sci. 2017 Nov;74(21):3913-25.

7. Scheuer C. Dan Med J. 2017 Jun;64(6). pii:B5358.

8. Skobowiat C et al. J Pineal Res. 2018 Sep;65(2):e12501.

9. Slominski AT et al. J Invest Dermatol. 2018 Mar;138(3):490-9.

10. Park EK et al. Int J Mol Sci. 2018 Jul 8;19(7). pii: E1995.

11. Kocyigit A et al. Mutat Res. 2018 May-Jun;829-30:50-60.

12. Bora NS et al. Regul Toxicol Pharmacol. 2017 Oct;89:1-12.

13. Juhasz MLW et al. J Cosmet Dermatol. 2018 Dec;17(6):1144-57.

14. Sagan D et al. Ann Agric Environ Med. 2017 Dec 23;24(4):659-66.

Recall that melatonin displays multiple biological functions, acting as an antioxidant, cytokine, neurotransmitter, and global regulator of the circadian clock, the latter for which it is best known.^1-3 At the cutaneous level, melatonin exhibits antioxidant (direct, as a radical scavenger; indirect, through upregulating antioxidant enzymes), anti-inflammatory, photoprotective, tissue regenerative, and cytoprotective activity, particularly in its capacity to preserve mitochondrial function.^4-8

Melatonin also protects skin homeostasis,⁶ and, consequently, is believed to act against carcinogenesis and potentially other deleterious dysfunctions such as hyperproliferative/inflammatory conditions.⁵ Notably, functional melatonin receptors are expressed in human skin and hair follicles, where melatonin is also produced, further buttressing the critical role that melatonin plays in skin health.⁵ Melatonin also displays immunomodulatory, thermoregulatory, and antitumor functions.⁹ The topical application of melatonin has been demonstrated to diminish markers of reactive oxygen species as well as reverse manifestations of cutaneous aging.⁵

Melatonin is both produced by and metabolized in the skin. The hormone and its metabolites (6-hydroxymelatonin, N¹-acetyl-N²-formyl-5-methoxykynuramine [AFMK], N-acetyl-serotonin, and 5-methoxytryptamine) reduce UVB-induced oxidative cell damage in human keratinocytes and melanocytes, and also act as radioprotectors.⁶

Melatonin has been shown to protect human dermal fibroblasts from UVA- and UVB-induced damage.⁹ In addition, melatonin and its metabolites have been demonstrated to suppress the growth of cultured human melanomas, and high doses of melatonin used in clinical trials in late metastatic melanoma stages have enhanced the efficacy of or diminished the side effects of chemotherapy/chemo-immunotherapy.⁹

UVB and melatonin in the lab

In a 2018 hairless mouse study in which animals were irradiated by UVB for 8 weeks, Park et al. showed that melatonin displays anti-wrinkle activity by suppressing reactive oxygen species- and sonic hedgehog-mediated inflammatory proteins. Melatonin also protected against transepidermal water loss and prevented epidermal thickness as well as dermal collagen degradation.¹⁰

Also that year, Skobowiat et al. found that the topical application of melatonin and its active derivatives (N1-acetyl-N2-formyl-5-methoxykynurenine and N-acetylserotonin) yielded photoprotective effects pre- and post-UVB treatment in human and porcine skin ex vivo. They concluded that their results justify additional investigation of the clinical applications of melatonin and its metabolites for its potential to exert protective effects against UVB in human subjects.⁸

Although the preponderance of previous work identifies melatonin as a strong antioxidant, Kocyigit et al. reported in 2018 on new in vitro studies suggesting that melatonin dose-dependently exerts cytotoxic and apoptotic activity on several cell types, including both human epidermoid carcinoma and normal skin fibroblasts. Their findings showed that melatonin exhibited proliferative effects on cancerous and normal cells at low doses and cytotoxic effects at high doses.¹¹
 

Melatonin as a sunscreen ingredient

Further supporting its use in the topical armamentarium for skin health, melatonin is a key ingredient in a sunscreen formulation, the creation of which was driven by the need to protect the skin of military personnel facing lengthy UV exposure. Specifically, the formulation containing avobenzone, octinoxate, oxybenzone, and titanium dioxide along with melatonin and pumpkin seed oil underwent a preclinical safety evaluation in 2017, as reported by Bora et al. The formulation was found to be nonmutagenic, nontoxic, and safe in animal models and is deemed ready to test for its efficacy in humans.¹² Melatonin is also among a host of systemic treatment options for skin lightening.¹³

Oral and topical melatonin in human studies

In a 2017 study on the impact of melatonin treatment on the skin of former smokers, Sagan et al. assessed oxidative damage to membrane lipids in blood serum and in epidermis exfoliated during microdermabrasion (at baseline, 2 weeks after, and 4 weeks after treatment) in postmenopausal women. Never smokers (n = 44) and former smokers (n = 46) were divided into control, melatonin topical, antioxidant topical, and melatonin oral treatment groups. The investigators found that after only 2 weeks, melatonin oral treatment significantly reversed the elevated serum lipid peroxidation in former smokers. Oral melatonin increased elasticity, moisture, and sebum levels after 4 weeks of treatment and topical melatonin increased sebum level. They concluded that the use of exogenous melatonin reverses the effects of oxidative damage to membrane lipids and ameliorates cutaneous biophysical traits in postmenopausal women who once smoked. The researchers added that melatonin use for all former smokers is warranted and that topically applied melatonin merits consideration for improving the effects of facial microdermabrasion.¹⁴

In a systematic literature review in 2017, Scheuer identified 20 studies (4 human and 16 experimental) indicating that melatonin exerts a protective effect against artificial UV-induced erythema when applied pre-exposure.⁷ Also that year, Scheuer and colleagues conducted randomized, double-blind, placebo-controlled work demonstrating that topical melatonin (12.5%) significantly reduced erythema resulting from natural sunlight, and in a separate randomized, double-blind, placebo-controlled crossover study that the same concentration of a full body application of melatonin exhibited no significant impact on cognition and should be considered safe for dermal application.⁷ Scheuer added that additional longitudinal research is needed to ascertain effects of topical melatonin usage over time.

Early in 2018, Milani and Sparavigna reported on a randomized, split-face, assessor-blinded, prospective 3-month study of 22 women (mean age 55 years) with moderate to severe facial skin aging; the study was designed to test the efficacy of melatonin-based day and night creams. All of the women completed the proof-of-concept trial in which crow’s feet were found to be significantly diminished on the sides of the face treated with the creams compared with the nontreated skin.

Image Source/getty images

Conclusion

The majority of research on the potent hormone melatonin over nearly the last quarter century indicates that this dynamic substance provides multifaceted benefits in performing several biological functions. Topical melatonin is available over the counter. Its expanded use in skin care warrants greater attention as we learn more about this versatile endogenous substance.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur who practices in Miami. She founded the Cosmetic Dermatology Center at the University of Miami in 1997. Dr. Baumann wrote two textbooks: “Cosmetic Dermatology: Principles and Practice” (New York: McGraw-Hill, 2002), and “Cosmeceuticals and Cosmetic Ingredients,” (New York: McGraw-Hill, 2014), and a New York Times Best Sellers book for consumers, “The Skin Type Solution” (New York: Bantam Dell, 2006). Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Evolus, Galderma, and Revance. She is the founder and CEO of Skin Type Solutions Franchise Systems LLC. Write to her at [email protected].

References

1. Zmijewski MA et al. Dermatoendocrinol. 2011 Jan;3(1):3-10.

2. Slominski A et al. Trends Endocrinol Metab. 2008 Jan;19(1):17-24.

3. Slominski A et al. J Cell Physiol. 2003 Jul;196(1):144-53.

4. Milani M et al. Clin Cosmet Investig Dermatol. 2018 Jan 24;11:51-7.

5. Day D et al. J Drugs Dermatol. 2018 Sep 1;17(9):966-9.

6. Slominski AT et al. Cell Mol Life Sci. 2017 Nov;74(21):3913-25.

7. Scheuer C. Dan Med J. 2017 Jun;64(6). pii:B5358.

8. Skobowiat C et al. J Pineal Res. 2018 Sep;65(2):e12501.

9. Slominski AT et al. J Invest Dermatol. 2018 Mar;138(3):490-9.

10. Park EK et al. Int J Mol Sci. 2018 Jul 8;19(7). pii: E1995.

11. Kocyigit A et al. Mutat Res. 2018 May-Jun;829-30:50-60.

12. Bora NS et al. Regul Toxicol Pharmacol. 2017 Oct;89:1-12.

13. Juhasz MLW et al. J Cosmet Dermatol. 2018 Dec;17(6):1144-57.

14. Sagan D et al. Ann Agric Environ Med. 2017 Dec 23;24(4):659-66.

The Food and Drug Administration has identified 457 unique cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) and 9 related deaths since 2010, and received 246 new medical device reports (MDRs) regarding BIA-ALCL between September 2017 and September 2018, according to an update from the agency’s Center for Devices and Radiological Health.

gorodenkoff/iStock/Getty Images Plus

That brings the total number of reports to 660; however, that number reflects duplicative cases, Binita Ashar, MD, a general surgeon and the director of the division of surgical devices at the center, said in a statement.

“These types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA,” Dr. Ashar said, addressing the high number of new reports. “The increased number of MDRs contributes to our evolving understanding of BIA-ALCL and represents a more thorough and comprehensive analysis.”

BIA-ALCL is a type of non-Hodgkin lymphoma and a known risk from breast implants that was first communicated by the FDA in 2011. Regular updates have been provided with respect to related medical device reports, cases, deaths, and known risks.

“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue,” Dr. Ashar said.

To that end, the center also issued a Letter to Health Care Providers to “encourage those who regularly treat patients, including primary care physicians and gynecologists, to learn about BIA-ALCL in patients with breast implants.”

Patients and providers are encouraged to file MDRs with the FDA via MedWatch, the FDA Safety Information and Adverse Event Reporting program, she said.

[email protected]

The Food and Drug Administration has identified 457 unique cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) and 9 related deaths since 2010, and received 246 new medical device reports (MDRs) regarding BIA-ALCL between September 2017 and September 2018, according to an update from the agency’s Center for Devices and Radiological Health.

gorodenkoff/iStock/Getty Images Plus

That brings the total number of reports to 660; however, that number reflects duplicative cases, Binita Ashar, MD, a general surgeon and the director of the division of surgical devices at the center, said in a statement.

“These types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA,” Dr. Ashar said, addressing the high number of new reports. “The increased number of MDRs contributes to our evolving understanding of BIA-ALCL and represents a more thorough and comprehensive analysis.”

BIA-ALCL is a type of non-Hodgkin lymphoma and a known risk from breast implants that was first communicated by the FDA in 2011. Regular updates have been provided with respect to related medical device reports, cases, deaths, and known risks.

“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue,” Dr. Ashar said.

To that end, the center also issued a Letter to Health Care Providers to “encourage those who regularly treat patients, including primary care physicians and gynecologists, to learn about BIA-ALCL in patients with breast implants.”

Patients and providers are encouraged to file MDRs with the FDA via MedWatch, the FDA Safety Information and Adverse Event Reporting program, she said.

[email protected]

The Food and Drug Administration has identified 457 unique cases of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) and 9 related deaths since 2010, and received 246 new medical device reports (MDRs) regarding BIA-ALCL between September 2017 and September 2018, according to an update from the agency’s Center for Devices and Radiological Health.

gorodenkoff/iStock/Getty Images Plus

That brings the total number of reports to 660; however, that number reflects duplicative cases, Binita Ashar, MD, a general surgeon and the director of the division of surgical devices at the center, said in a statement.

“These types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA,” Dr. Ashar said, addressing the high number of new reports. “The increased number of MDRs contributes to our evolving understanding of BIA-ALCL and represents a more thorough and comprehensive analysis.”

BIA-ALCL is a type of non-Hodgkin lymphoma and a known risk from breast implants that was first communicated by the FDA in 2011. Regular updates have been provided with respect to related medical device reports, cases, deaths, and known risks.

“We hope that this information prompts providers and patients to have important, informed conversations about breast implants and the risk of BIA-ALCL. At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue,” Dr. Ashar said.

To that end, the center also issued a Letter to Health Care Providers to “encourage those who regularly treat patients, including primary care physicians and gynecologists, to learn about BIA-ALCL in patients with breast implants.”

Patients and providers are encouraged to file MDRs with the FDA via MedWatch, the FDA Safety Information and Adverse Event Reporting program, she said.

[email protected]