Doug Brunk

Denver – When Anne Chapas, MD, was asked to help conduct a clinical trial of a wearable, hands-free device for remodeling of the face and submental area, she responded with a healthy dose of skepticism.

“My first thought was, ‘this is crazy. It looks like a Storm Trooper helmet,’ ” Dr. Chapas, founder and medical director of UnionDerm, New York, said at the annual meeting of the American Society for Dermatologic Surgery. “But it’s the first FDA-cleared device that uses bipolar radiofrequency to target the lower third of the face and the submental area of the face. We wanted to see how it works.”

The device, Evoke, is the first cleared thermal facial and submental remodeling platform in the industry. Its bipolar radiofrequency (RF) component reaches 4 mm in depth and travels from central to outer electrodes. The device features real-time temperature monitoring and the ability to delivery energy at lower temps for longer periods of time compared with hands-on approaches. No cooling is required.

“It is able to treat a large surface area simultaneously to achieve maximal tissue contraction,” Dr. Chapas said. “What we’ve learned in decades of RF technology is that it’s not just about heat. It has to be the right amount of heat for the right amount of time. That’s what’s difficult when we’re doing our own individual treatments. How many pulses do we need? How is that heat dissipating? Are we getting the amount of heat we need? Is the patient in pain? We need to take that data from the individual provider and come up with an automated system. That’s what this device is trying to accomplish.”

In a prospective trial, she and her colleagues enrolled 40 patients between the ages of 36 and 75 years with visible signs of facial aging who were seeking skin tightening treatments at one of three centers in the United States. They underwent three biweekly treatments with the Evoke device to the lower face and submental area where a target temperature of 42°-43° C was maintained for 41 minutes, or about 20 minutes for each site.

For the primary safety endpoint, investigators and blinded evaluators used a 4-point Likert scale before treatment, and 1, 3, and 6 months post-treatment. Follow-up visit satisfaction metrics were the patient’s skin appearance evaluation and overall satisfaction, and the investigator improvement rating based on an analysis of volumetric data from 3D imaging software. Chin and cheek discomfort metrics were assessed at all treatments. The subject satisfaction metrics were measured on an 11-point scale where 0 is most comfortable and 10 is most uncomfortable.

In terms of safety, patients tolerated the treatments well and rated their average discomfort from 0.643 to 1.45 on the 11-point Likert scale. “The subject satisfaction rate was about 80%, which is in line with other devices, such as microfocused ultrasound,” said Dr. Chapas, who is also a clinical instructor of dermatology at the Mount Sinai Medical Center, New York.

“The physicians were a little tougher on their assessments. We felt there was about a 65%-70% success rate after the three treatment timepoints.” One possible reason for the disparity between the patient and physician assessments is that patients “may be more accepting of meager results from a hands-free treatment.”

Expect to see more hands-free devices hit the dermatology market in the coming months and years ahead, Dr. Chapas said. Before clinicians incorporate such systems into their practices, she advises them to review existing evidence for the technology, including published data and asking for demonstrations. “If it’s not efficacious, you’ve just wasted everybody’s time,” she said. “Also, is it practical for your office? Do you have the space for it? What staff training is involved? Is it truly automated?”

She added, “If you have a device that’s hands-free but someone must stay in the room with the patient for an hour, does that really help the flow of your practice? And finally, what do your patients want? Do they want to come back multiple times, or do they prefer one-and-done treatments?”

Other questions to consider, she said, include, who benefits from these treatments. Does it fill an unmet need for patients, and for clinicians? Does it help with operator fatigue? How are more consistent treatments achieved? Can the technology be applied to broad body areas?

“The hands-free revolution has been building,” Dr. Chapas commented. “The next generation of lasers and energy devices are going to be coming into our offices, so we should think carefully about how to incorporate them.”

Dr. Chapas disclosed that she is an investigator for InMode (the manufacturer of Evoke), Cutera, and Galderma, and a speaker for Allergan.

Denver – When Anne Chapas, MD, was asked to help conduct a clinical trial of a wearable, hands-free device for remodeling of the face and submental area, she responded with a healthy dose of skepticism.

“My first thought was, ‘this is crazy. It looks like a Storm Trooper helmet,’ ” Dr. Chapas, founder and medical director of UnionDerm, New York, said at the annual meeting of the American Society for Dermatologic Surgery. “But it’s the first FDA-cleared device that uses bipolar radiofrequency to target the lower third of the face and the submental area of the face. We wanted to see how it works.”

The device, Evoke, is the first cleared thermal facial and submental remodeling platform in the industry. Its bipolar radiofrequency (RF) component reaches 4 mm in depth and travels from central to outer electrodes. The device features real-time temperature monitoring and the ability to delivery energy at lower temps for longer periods of time compared with hands-on approaches. No cooling is required.

“It is able to treat a large surface area simultaneously to achieve maximal tissue contraction,” Dr. Chapas said. “What we’ve learned in decades of RF technology is that it’s not just about heat. It has to be the right amount of heat for the right amount of time. That’s what’s difficult when we’re doing our own individual treatments. How many pulses do we need? How is that heat dissipating? Are we getting the amount of heat we need? Is the patient in pain? We need to take that data from the individual provider and come up with an automated system. That’s what this device is trying to accomplish.”

In a prospective trial, she and her colleagues enrolled 40 patients between the ages of 36 and 75 years with visible signs of facial aging who were seeking skin tightening treatments at one of three centers in the United States. They underwent three biweekly treatments with the Evoke device to the lower face and submental area where a target temperature of 42°-43° C was maintained for 41 minutes, or about 20 minutes for each site.

For the primary safety endpoint, investigators and blinded evaluators used a 4-point Likert scale before treatment, and 1, 3, and 6 months post-treatment. Follow-up visit satisfaction metrics were the patient’s skin appearance evaluation and overall satisfaction, and the investigator improvement rating based on an analysis of volumetric data from 3D imaging software. Chin and cheek discomfort metrics were assessed at all treatments. The subject satisfaction metrics were measured on an 11-point scale where 0 is most comfortable and 10 is most uncomfortable.

In terms of safety, patients tolerated the treatments well and rated their average discomfort from 0.643 to 1.45 on the 11-point Likert scale. “The subject satisfaction rate was about 80%, which is in line with other devices, such as microfocused ultrasound,” said Dr. Chapas, who is also a clinical instructor of dermatology at the Mount Sinai Medical Center, New York.

“The physicians were a little tougher on their assessments. We felt there was about a 65%-70% success rate after the three treatment timepoints.” One possible reason for the disparity between the patient and physician assessments is that patients “may be more accepting of meager results from a hands-free treatment.”

Expect to see more hands-free devices hit the dermatology market in the coming months and years ahead, Dr. Chapas said. Before clinicians incorporate such systems into their practices, she advises them to review existing evidence for the technology, including published data and asking for demonstrations. “If it’s not efficacious, you’ve just wasted everybody’s time,” she said. “Also, is it practical for your office? Do you have the space for it? What staff training is involved? Is it truly automated?”

She added, “If you have a device that’s hands-free but someone must stay in the room with the patient for an hour, does that really help the flow of your practice? And finally, what do your patients want? Do they want to come back multiple times, or do they prefer one-and-done treatments?”

Other questions to consider, she said, include, who benefits from these treatments. Does it fill an unmet need for patients, and for clinicians? Does it help with operator fatigue? How are more consistent treatments achieved? Can the technology be applied to broad body areas?

“The hands-free revolution has been building,” Dr. Chapas commented. “The next generation of lasers and energy devices are going to be coming into our offices, so we should think carefully about how to incorporate them.”

Dr. Chapas disclosed that she is an investigator for InMode (the manufacturer of Evoke), Cutera, and Galderma, and a speaker for Allergan.

Denver – When Anne Chapas, MD, was asked to help conduct a clinical trial of a wearable, hands-free device for remodeling of the face and submental area, she responded with a healthy dose of skepticism.

“My first thought was, ‘this is crazy. It looks like a Storm Trooper helmet,’ ” Dr. Chapas, founder and medical director of UnionDerm, New York, said at the annual meeting of the American Society for Dermatologic Surgery. “But it’s the first FDA-cleared device that uses bipolar radiofrequency to target the lower third of the face and the submental area of the face. We wanted to see how it works.”

The device, Evoke, is the first cleared thermal facial and submental remodeling platform in the industry. Its bipolar radiofrequency (RF) component reaches 4 mm in depth and travels from central to outer electrodes. The device features real-time temperature monitoring and the ability to delivery energy at lower temps for longer periods of time compared with hands-on approaches. No cooling is required.

“It is able to treat a large surface area simultaneously to achieve maximal tissue contraction,” Dr. Chapas said. “What we’ve learned in decades of RF technology is that it’s not just about heat. It has to be the right amount of heat for the right amount of time. That’s what’s difficult when we’re doing our own individual treatments. How many pulses do we need? How is that heat dissipating? Are we getting the amount of heat we need? Is the patient in pain? We need to take that data from the individual provider and come up with an automated system. That’s what this device is trying to accomplish.”

In a prospective trial, she and her colleagues enrolled 40 patients between the ages of 36 and 75 years with visible signs of facial aging who were seeking skin tightening treatments at one of three centers in the United States. They underwent three biweekly treatments with the Evoke device to the lower face and submental area where a target temperature of 42°-43° C was maintained for 41 minutes, or about 20 minutes for each site.

For the primary safety endpoint, investigators and blinded evaluators used a 4-point Likert scale before treatment, and 1, 3, and 6 months post-treatment. Follow-up visit satisfaction metrics were the patient’s skin appearance evaluation and overall satisfaction, and the investigator improvement rating based on an analysis of volumetric data from 3D imaging software. Chin and cheek discomfort metrics were assessed at all treatments. The subject satisfaction metrics were measured on an 11-point scale where 0 is most comfortable and 10 is most uncomfortable.

In terms of safety, patients tolerated the treatments well and rated their average discomfort from 0.643 to 1.45 on the 11-point Likert scale. “The subject satisfaction rate was about 80%, which is in line with other devices, such as microfocused ultrasound,” said Dr. Chapas, who is also a clinical instructor of dermatology at the Mount Sinai Medical Center, New York.

“The physicians were a little tougher on their assessments. We felt there was about a 65%-70% success rate after the three treatment timepoints.” One possible reason for the disparity between the patient and physician assessments is that patients “may be more accepting of meager results from a hands-free treatment.”

Expect to see more hands-free devices hit the dermatology market in the coming months and years ahead, Dr. Chapas said. Before clinicians incorporate such systems into their practices, she advises them to review existing evidence for the technology, including published data and asking for demonstrations. “If it’s not efficacious, you’ve just wasted everybody’s time,” she said. “Also, is it practical for your office? Do you have the space for it? What staff training is involved? Is it truly automated?”

She added, “If you have a device that’s hands-free but someone must stay in the room with the patient for an hour, does that really help the flow of your practice? And finally, what do your patients want? Do they want to come back multiple times, or do they prefer one-and-done treatments?”

Other questions to consider, she said, include, who benefits from these treatments. Does it fill an unmet need for patients, and for clinicians? Does it help with operator fatigue? How are more consistent treatments achieved? Can the technology be applied to broad body areas?

“The hands-free revolution has been building,” Dr. Chapas commented. “The next generation of lasers and energy devices are going to be coming into our offices, so we should think carefully about how to incorporate them.”

Dr. Chapas disclosed that she is an investigator for InMode (the manufacturer of Evoke), Cutera, and Galderma, and a speaker for Allergan.

DENVER – A stepwise method that combines surgical debulking and fractionated ablative laser was effective for treating elderly individuals with severe rhinophyma, results from a series of three patients demonstrated.

Rhinophyma occurs primarily in the sixth and seventh decades of life and is marked by facial hypertrophy that leads to tumor-like growth, inflammation, fibrosis, and loss of the cosmetic nasal subunits. “When it becomes severe it leads to a degree of embarrassment as well,” one of the study authors, Patricia Richey, MD, said during an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery. “We found that our method has been efficacious, but most often, and more importantly, leads to an improvement in the patient’s quality of life.”

To date, clinicians have used fully ablative lasers to treat varying degrees of rhinophyma but at a cost of prolonged healing time and higher rates of scarring and pigment or textural changes. However, not all dermatologists use full-field ablative lasers in their practices.

“Fractionated ablative lasers have been used in the past for mild to moderate rhinophyma, but they cannot ablate to 100% density, which would be necessary to debulk the marked hypertrophy present in our patients,” said Dr. Richey, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., and conducts research for the Wellman Center for Photomedicine and the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital, Boston. “That’s why we added a surgical component.”

She and colleague Mathew M. Avram, MD, JD, developed a three-step method for treating severe rhinophyma that they performed on three elderly patients. Step 1 is the surgical debulk. Following infiltration of local anesthesia, a razor blade or 15-blade is used to excise the most prominent lobules of hypertrophied sebaceous tissue down to the fibrofatty layer of the nose as a partial thickness excision that does not reach the level of the perichondrium or cartilage. “Hemostasis is achieved with electrocoagulation and application of petrolatum ointment, followed by a pressure dressing,” Dr. Richey said. “The location of the debulk varies by patient.”

Step 2 involves fractionated ablative laser treatment 4 weeks later with either the CO₂ or erbium:YAG (Er:YAG) 2,940-nm laser. According to Dr. Richey, the typical setting for the fractionated CO₂ is a fluence of 70mJ/cm² and a high density, performing six out of four passes with 60 seconds between each pass, “though these settings may vary based on the patient presentation,” she said.

The treatment level ranges from 5 (14% density) to 10 (70% density, for the most severe cases). Meanwhile, a representative setting for the ablative fractionated Er:YAG 2,940-nm laser is 250 mcm, no coagulation, 5.5% density, and one pass. “If a second surgical debulk is performed on the same day as ablative laser treatment, the sites of shave removal are typically avoided with the laser,” she said. If a certain portion of the nose has recently healed following surgical debulk 4 weeks prior, they may perform only two passes in this region.

In an interview, Dr. Avram, who directs the MGH Dermatology Laser and Cosmetic Center, characterized the staged method as providing “transformative change to severe, cosmetically disfiguring rhinophyma. The ablative fractional laser provides more fine-tuned contouring.”

The three patients studied had an average of three to four monthly treatments. “There is typically a great deal of improvement by the second treatment,” Dr. Richey said. Add-on treatments may include low voltage electrodessication at 1.8 watts for patients with well-demarcated papules of sebaceous hyperplasia, and a vascular laser such as the pulsed dye laser if telangiectasias are present.

One limitation of the stepwise method, she said, is that the surgical debulk typically results in a scar, “but it’s rarely noticeable if carefully performed, likely due to fractionated ablative use during the scar remodeling period. It’s important to set expectations with your patient at the initial consult. We always discuss treatment goals and that while we aim achieve the most desirable outcome possible, we’re never going to get them back to having a completely normal nose. They’re always going to have some mild or moderate rhinophymatous changes present.”

Vincent Richer, MD, a Vancouver-based medical and cosmetic dermatologist who was asked to comment on these results, characterized the stepwise method as promising. “Though more treatments are required, the easier recovery, safe outcomes in the case presented and excellent cosmetic result made it an interesting alternative when fully ablative resurfacing is daunting, either for patients or physicians involved,” he said in an interview.

The researchers reported having no relevant disclosures. Dr. Richer disclosed that he performs clinical trials for AbbVie/Allergan, Galderma, Leo Pharma, Pfizer, and is a member of advisory board for Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, and Sanofi. He is also a consultant to AbbVie/Allergan, Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, Merz, and Sanofi.

DENVER – A stepwise method that combines surgical debulking and fractionated ablative laser was effective for treating elderly individuals with severe rhinophyma, results from a series of three patients demonstrated.

Rhinophyma occurs primarily in the sixth and seventh decades of life and is marked by facial hypertrophy that leads to tumor-like growth, inflammation, fibrosis, and loss of the cosmetic nasal subunits. “When it becomes severe it leads to a degree of embarrassment as well,” one of the study authors, Patricia Richey, MD, said during an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery. “We found that our method has been efficacious, but most often, and more importantly, leads to an improvement in the patient’s quality of life.”

To date, clinicians have used fully ablative lasers to treat varying degrees of rhinophyma but at a cost of prolonged healing time and higher rates of scarring and pigment or textural changes. However, not all dermatologists use full-field ablative lasers in their practices.

“Fractionated ablative lasers have been used in the past for mild to moderate rhinophyma, but they cannot ablate to 100% density, which would be necessary to debulk the marked hypertrophy present in our patients,” said Dr. Richey, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., and conducts research for the Wellman Center for Photomedicine and the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital, Boston. “That’s why we added a surgical component.”

She and colleague Mathew M. Avram, MD, JD, developed a three-step method for treating severe rhinophyma that they performed on three elderly patients. Step 1 is the surgical debulk. Following infiltration of local anesthesia, a razor blade or 15-blade is used to excise the most prominent lobules of hypertrophied sebaceous tissue down to the fibrofatty layer of the nose as a partial thickness excision that does not reach the level of the perichondrium or cartilage. “Hemostasis is achieved with electrocoagulation and application of petrolatum ointment, followed by a pressure dressing,” Dr. Richey said. “The location of the debulk varies by patient.”

Step 2 involves fractionated ablative laser treatment 4 weeks later with either the CO₂ or erbium:YAG (Er:YAG) 2,940-nm laser. According to Dr. Richey, the typical setting for the fractionated CO₂ is a fluence of 70mJ/cm² and a high density, performing six out of four passes with 60 seconds between each pass, “though these settings may vary based on the patient presentation,” she said.

The treatment level ranges from 5 (14% density) to 10 (70% density, for the most severe cases). Meanwhile, a representative setting for the ablative fractionated Er:YAG 2,940-nm laser is 250 mcm, no coagulation, 5.5% density, and one pass. “If a second surgical debulk is performed on the same day as ablative laser treatment, the sites of shave removal are typically avoided with the laser,” she said. If a certain portion of the nose has recently healed following surgical debulk 4 weeks prior, they may perform only two passes in this region.

In an interview, Dr. Avram, who directs the MGH Dermatology Laser and Cosmetic Center, characterized the staged method as providing “transformative change to severe, cosmetically disfiguring rhinophyma. The ablative fractional laser provides more fine-tuned contouring.”

The three patients studied had an average of three to four monthly treatments. “There is typically a great deal of improvement by the second treatment,” Dr. Richey said. Add-on treatments may include low voltage electrodessication at 1.8 watts for patients with well-demarcated papules of sebaceous hyperplasia, and a vascular laser such as the pulsed dye laser if telangiectasias are present.

One limitation of the stepwise method, she said, is that the surgical debulk typically results in a scar, “but it’s rarely noticeable if carefully performed, likely due to fractionated ablative use during the scar remodeling period. It’s important to set expectations with your patient at the initial consult. We always discuss treatment goals and that while we aim achieve the most desirable outcome possible, we’re never going to get them back to having a completely normal nose. They’re always going to have some mild or moderate rhinophymatous changes present.”

Vincent Richer, MD, a Vancouver-based medical and cosmetic dermatologist who was asked to comment on these results, characterized the stepwise method as promising. “Though more treatments are required, the easier recovery, safe outcomes in the case presented and excellent cosmetic result made it an interesting alternative when fully ablative resurfacing is daunting, either for patients or physicians involved,” he said in an interview.

The researchers reported having no relevant disclosures. Dr. Richer disclosed that he performs clinical trials for AbbVie/Allergan, Galderma, Leo Pharma, Pfizer, and is a member of advisory board for Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, and Sanofi. He is also a consultant to AbbVie/Allergan, Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, Merz, and Sanofi.

DENVER – A stepwise method that combines surgical debulking and fractionated ablative laser was effective for treating elderly individuals with severe rhinophyma, results from a series of three patients demonstrated.

Rhinophyma occurs primarily in the sixth and seventh decades of life and is marked by facial hypertrophy that leads to tumor-like growth, inflammation, fibrosis, and loss of the cosmetic nasal subunits. “When it becomes severe it leads to a degree of embarrassment as well,” one of the study authors, Patricia Richey, MD, said during an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery. “We found that our method has been efficacious, but most often, and more importantly, leads to an improvement in the patient’s quality of life.”

To date, clinicians have used fully ablative lasers to treat varying degrees of rhinophyma but at a cost of prolonged healing time and higher rates of scarring and pigment or textural changes. However, not all dermatologists use full-field ablative lasers in their practices.

“Fractionated ablative lasers have been used in the past for mild to moderate rhinophyma, but they cannot ablate to 100% density, which would be necessary to debulk the marked hypertrophy present in our patients,” said Dr. Richey, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., and conducts research for the Wellman Center for Photomedicine and the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital, Boston. “That’s why we added a surgical component.”

She and colleague Mathew M. Avram, MD, JD, developed a three-step method for treating severe rhinophyma that they performed on three elderly patients. Step 1 is the surgical debulk. Following infiltration of local anesthesia, a razor blade or 15-blade is used to excise the most prominent lobules of hypertrophied sebaceous tissue down to the fibrofatty layer of the nose as a partial thickness excision that does not reach the level of the perichondrium or cartilage. “Hemostasis is achieved with electrocoagulation and application of petrolatum ointment, followed by a pressure dressing,” Dr. Richey said. “The location of the debulk varies by patient.”

Step 2 involves fractionated ablative laser treatment 4 weeks later with either the CO₂ or erbium:YAG (Er:YAG) 2,940-nm laser. According to Dr. Richey, the typical setting for the fractionated CO₂ is a fluence of 70mJ/cm² and a high density, performing six out of four passes with 60 seconds between each pass, “though these settings may vary based on the patient presentation,” she said.

The treatment level ranges from 5 (14% density) to 10 (70% density, for the most severe cases). Meanwhile, a representative setting for the ablative fractionated Er:YAG 2,940-nm laser is 250 mcm, no coagulation, 5.5% density, and one pass. “If a second surgical debulk is performed on the same day as ablative laser treatment, the sites of shave removal are typically avoided with the laser,” she said. If a certain portion of the nose has recently healed following surgical debulk 4 weeks prior, they may perform only two passes in this region.

In an interview, Dr. Avram, who directs the MGH Dermatology Laser and Cosmetic Center, characterized the staged method as providing “transformative change to severe, cosmetically disfiguring rhinophyma. The ablative fractional laser provides more fine-tuned contouring.”

The three patients studied had an average of three to four monthly treatments. “There is typically a great deal of improvement by the second treatment,” Dr. Richey said. Add-on treatments may include low voltage electrodessication at 1.8 watts for patients with well-demarcated papules of sebaceous hyperplasia, and a vascular laser such as the pulsed dye laser if telangiectasias are present.

One limitation of the stepwise method, she said, is that the surgical debulk typically results in a scar, “but it’s rarely noticeable if carefully performed, likely due to fractionated ablative use during the scar remodeling period. It’s important to set expectations with your patient at the initial consult. We always discuss treatment goals and that while we aim achieve the most desirable outcome possible, we’re never going to get them back to having a completely normal nose. They’re always going to have some mild or moderate rhinophymatous changes present.”

Vincent Richer, MD, a Vancouver-based medical and cosmetic dermatologist who was asked to comment on these results, characterized the stepwise method as promising. “Though more treatments are required, the easier recovery, safe outcomes in the case presented and excellent cosmetic result made it an interesting alternative when fully ablative resurfacing is daunting, either for patients or physicians involved,” he said in an interview.

The researchers reported having no relevant disclosures. Dr. Richer disclosed that he performs clinical trials for AbbVie/Allergan, Galderma, Leo Pharma, Pfizer, and is a member of advisory board for Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, and Sanofi. He is also a consultant to AbbVie/Allergan, Bausch, Celgene, Eli Lilly, Galderma, Janssen, Johnson & Johnson, Leo Pharma, L’Oréal, Merz, and Sanofi.

Denver – Combining 1,550-nm nonablative fractional resurfacing (NAFR) and laser hair removal (LHR) on the same day of treatment safely improves both hyperpigmentation and hypertrichosis in Becker’s nevi patients out to 40 weeks, results of a small retrospective case series demonstrated.

During an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery, presenting author Shelby L. Kubicki, MD, said that NAFR and LHR target the clinically bothersome Becker’s nevi features of hyperpigmentation and hypertrichosis via different mechanisms. “NAFR creates microcolumns of thermal injury in the skin, which improves hyperpigmentation,” explained Dr. Kubicki, a 3rd-year dermatology resident at University of Texas Health Sciences Center/University of Texas MD Anderson Cancer Center, both in Houston.

“LHR targets follicular melanocytes, which are located more deeply in the dermis,” she said. “This improves hypertrichosis and likely prevents recurrence of hyperpigmentation by targeting these melanocytes that are not reached by NAFR.”

Dr. Kubicki and her colleagues retrospectively reviewed 12 patients with Becker’s nevus who underwent a mean of 5.3 NAFR treatments at a single dermatology practice at intervals that ranged between 1 and 4 months. The long-pulsed 755-nm alexandrite laser was used for study participants with skin types I-III, while the long-pulsed 1,064-nm Nd: YAG laser was used for those with skin types IV-VI. Ten of the 12 patients underwent concomitant LHR with one of the two devices and three independent physicians used a 5-point visual analog scale (VAS) to rate clinical photographs. All patients completed a strict pre- and postoperative regimen with either 4% hydroquinone or topical 3% tranexamic acid and broad-spectrum sunscreen and postoperative treatment with a midpotency topical corticosteroid for 3 days.

The study is the largest known case series of therapy combining 1,550-nm NAFR and LHR for Becker’s nevus patients with skin types III-VI.

After comparing VAS scores at baseline and follow-up, physicians rated the cosmetic appearance of Becker’s nevus as improving by a range of 51%-75%. Two patients did not undergo LHR: one male patient with Becker’s nevus in his beard region, for whom LHR was undesirable, and a second patient with atrichotic Becker’s nevus. These two patients demonstrated improvements in VAS scores of 26%-50% and 76%-99%, respectively.

No long-term adverse events were observed during follow-up, which ranged from 6 to 40 weeks. “We do want more long-term follow-up,” Dr. Kubicki said, noting that there are more data on some patients to extend the follow-up.

She and her coinvestigators concluded that the results show that treatment with a combination of NAFR and LHR safely addresses both hyperpigmentation and hypertrichosis in Becker’s nevi. “In addition, LHR likely prevents recurrence of hyperpigmentation by targeting follicular melanocytes,” she said. “In our study, we did have one patient experience recurrence of a Becker’s nevus during follow-up, but [the rest] did not, which we considered a success.”

Denver – Combining 1,550-nm nonablative fractional resurfacing (NAFR) and laser hair removal (LHR) on the same day of treatment safely improves both hyperpigmentation and hypertrichosis in Becker’s nevi patients out to 40 weeks, results of a small retrospective case series demonstrated.

During an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery, presenting author Shelby L. Kubicki, MD, said that NAFR and LHR target the clinically bothersome Becker’s nevi features of hyperpigmentation and hypertrichosis via different mechanisms. “NAFR creates microcolumns of thermal injury in the skin, which improves hyperpigmentation,” explained Dr. Kubicki, a 3rd-year dermatology resident at University of Texas Health Sciences Center/University of Texas MD Anderson Cancer Center, both in Houston.

“LHR targets follicular melanocytes, which are located more deeply in the dermis,” she said. “This improves hypertrichosis and likely prevents recurrence of hyperpigmentation by targeting these melanocytes that are not reached by NAFR.”

Dr. Kubicki and her colleagues retrospectively reviewed 12 patients with Becker’s nevus who underwent a mean of 5.3 NAFR treatments at a single dermatology practice at intervals that ranged between 1 and 4 months. The long-pulsed 755-nm alexandrite laser was used for study participants with skin types I-III, while the long-pulsed 1,064-nm Nd: YAG laser was used for those with skin types IV-VI. Ten of the 12 patients underwent concomitant LHR with one of the two devices and three independent physicians used a 5-point visual analog scale (VAS) to rate clinical photographs. All patients completed a strict pre- and postoperative regimen with either 4% hydroquinone or topical 3% tranexamic acid and broad-spectrum sunscreen and postoperative treatment with a midpotency topical corticosteroid for 3 days.

The study is the largest known case series of therapy combining 1,550-nm NAFR and LHR for Becker’s nevus patients with skin types III-VI.

After comparing VAS scores at baseline and follow-up, physicians rated the cosmetic appearance of Becker’s nevus as improving by a range of 51%-75%. Two patients did not undergo LHR: one male patient with Becker’s nevus in his beard region, for whom LHR was undesirable, and a second patient with atrichotic Becker’s nevus. These two patients demonstrated improvements in VAS scores of 26%-50% and 76%-99%, respectively.

No long-term adverse events were observed during follow-up, which ranged from 6 to 40 weeks. “We do want more long-term follow-up,” Dr. Kubicki said, noting that there are more data on some patients to extend the follow-up.

She and her coinvestigators concluded that the results show that treatment with a combination of NAFR and LHR safely addresses both hyperpigmentation and hypertrichosis in Becker’s nevi. “In addition, LHR likely prevents recurrence of hyperpigmentation by targeting follicular melanocytes,” she said. “In our study, we did have one patient experience recurrence of a Becker’s nevus during follow-up, but [the rest] did not, which we considered a success.”

Denver – Combining 1,550-nm nonablative fractional resurfacing (NAFR) and laser hair removal (LHR) on the same day of treatment safely improves both hyperpigmentation and hypertrichosis in Becker’s nevi patients out to 40 weeks, results of a small retrospective case series demonstrated.

During an oral abstract session at the annual meeting of the American Society for Dermatologic Surgery, presenting author Shelby L. Kubicki, MD, said that NAFR and LHR target the clinically bothersome Becker’s nevi features of hyperpigmentation and hypertrichosis via different mechanisms. “NAFR creates microcolumns of thermal injury in the skin, which improves hyperpigmentation,” explained Dr. Kubicki, a 3rd-year dermatology resident at University of Texas Health Sciences Center/University of Texas MD Anderson Cancer Center, both in Houston.

“LHR targets follicular melanocytes, which are located more deeply in the dermis,” she said. “This improves hypertrichosis and likely prevents recurrence of hyperpigmentation by targeting these melanocytes that are not reached by NAFR.”

Dr. Kubicki and her colleagues retrospectively reviewed 12 patients with Becker’s nevus who underwent a mean of 5.3 NAFR treatments at a single dermatology practice at intervals that ranged between 1 and 4 months. The long-pulsed 755-nm alexandrite laser was used for study participants with skin types I-III, while the long-pulsed 1,064-nm Nd: YAG laser was used for those with skin types IV-VI. Ten of the 12 patients underwent concomitant LHR with one of the two devices and three independent physicians used a 5-point visual analog scale (VAS) to rate clinical photographs. All patients completed a strict pre- and postoperative regimen with either 4% hydroquinone or topical 3% tranexamic acid and broad-spectrum sunscreen and postoperative treatment with a midpotency topical corticosteroid for 3 days.

The study is the largest known case series of therapy combining 1,550-nm NAFR and LHR for Becker’s nevus patients with skin types III-VI.

After comparing VAS scores at baseline and follow-up, physicians rated the cosmetic appearance of Becker’s nevus as improving by a range of 51%-75%. Two patients did not undergo LHR: one male patient with Becker’s nevus in his beard region, for whom LHR was undesirable, and a second patient with atrichotic Becker’s nevus. These two patients demonstrated improvements in VAS scores of 26%-50% and 76%-99%, respectively.

No long-term adverse events were observed during follow-up, which ranged from 6 to 40 weeks. “We do want more long-term follow-up,” Dr. Kubicki said, noting that there are more data on some patients to extend the follow-up.

She and her coinvestigators concluded that the results show that treatment with a combination of NAFR and LHR safely addresses both hyperpigmentation and hypertrichosis in Becker’s nevi. “In addition, LHR likely prevents recurrence of hyperpigmentation by targeting follicular melanocytes,” she said. “In our study, we did have one patient experience recurrence of a Becker’s nevus during follow-up, but [the rest] did not, which we considered a success.”

Most patients with chronic urticaria (CU) used treatment during pregnancy, especially with second-generation antihistamines, which appear to be safe regardless of the trimester. In addition, the rates of preterm births and medical problems of newborns in patients with CU are similar to those of the normal population and not linked to treatment used during pregnancy.

Those are the key findings from an analysis of new data from PREG-CU, an international, multicenter study of the Urticaria Centers of Reference and Excellence (UCARE) network. Results from the first PREG-CU analysis published in 2021 found that CU improved in about half of patients with CU during pregnancy. “However, two in five patients reported acute exacerbations of CU especially at the beginning and end of pregnancy,” investigators led by Emek Kocatürk, MD, of the department of dermatology and UCARE at Koç University School of Medicine, Istanbul, wrote in the new study, recently published in the Journal of the European Academy of Dermatology and Venereology.

“In addition, 1 in 10 pregnant CU patients required urticaria emergency care and 1 of 6 had angioedema during pregnancy,” they said. Risk factors for worsening CU during pregnancy, they added, were “mild disease and no angioedema before pregnancy, not taking treatment before pregnancy, chronic inducible urticaria, CU worsening during a previous pregnancy, stress as a driver of exacerbations, and treatment during pregnancy.”
 

Analysis involved 288 pregnant women

To optimize treatment of CU during pregnancy and to better understand how treatment affects pregnancy outcomes, the researchers analyzed 288 pregnancies in 288 women with CU from 13 countries and 21 centers worldwide. Their mean age at pregnancy was 32.1 years, and their mean duration of CU was 84.9 months. Prior to pregnancy, 35.7% of patients rated the severity of their CU symptoms as mild, 34.2% rated it as moderate, and 29.7% rated it as severe.

The researchers found that during pregnancy, 60% of patients used urticaria medication, including standard-dose second-generation H1-antihistamines (35.1%), first-generation H1-antihistamines (7.6%), high-dose second-generation H1-antihistamines (5.6%), and omalizumab (5.6%). The preterm birth rate was 10.2%, which was similar between patients who did and did not receive treatment during pregnancy (11.6% vs. 8.7%, respectively; P = .59).

On multivariate logistic regression, two predictors for preterm birth emerged: giving birth to twins (a 13.3-fold increased risk; P = .016) and emergency referrals for CU (a 4.3-fold increased risk; P =.016). The cesarean delivery rate was 51.3%, and more than 90% of newborns were healthy at birth. There was no link between any patient or disease characteristics or treatments and medical problems at birth.

In other findings, 78.8% of women with CU breastfed their babies. Of the 58 patients who did not breastfeed, 20.7% indicated severe urticaria/angioedema and/or taking medications as the main reason for not breastfeeding.

“Most CU patients use treatment during pregnancy and such treatments, especially second generation H1 antihistamines, seem to be safe during pregnancy regardless of the trimester,” the researchers concluded. “Outcomes of pregnancy in patients with CU were similar compared to the general population and not linked to treatment used during pregnancy. Notably, emergency referral for CU was an independent risk factor for preterm birth,” and the high cesarean delivery rate was “probably linked to comorbidities associated with the disease,” they added. “Overall, these findings suggest that patients should continue their treatments using an individualized dose to provide optimal symptom control.”


 

International guidelines

The authors noted that international guidelines for the management of urticaria published in 2022 suggest that modern second-generation H1-antihistamines should be used for pregnant patients, preferably loratadine with a possible extrapolation to desloratadine, cetirizine, or levocetirizine.

“Similarly, in this population, we found that cetirizine and loratadine were the most commonly used antihistamines, followed by levocetirizine and fexofenadine,” Dr. Kocatürk and colleagues wrote.

“Guidelines also suggest that the use of first-generation H1-antihistamines should be avoided given their sedative effects; but if these are to be given, it would be wise to know that use of first-generation H1-antihistamines immediately before parturition could cause respiratory depression and other adverse effects in the neonate,” they added, noting that chlorpheniramine and diphenhydramine are the first-generation H1-antihistamines with the greatest evidence of safety in pregnancy.

They acknowledged certain limitations of the analysis, including its retrospective design and the fact that there were no data on low birth weight, small for gestational age, or miscarriage rates. In addition, disease activity or severity during pregnancy and after birth were not monitored.

Asked to comment on these results, Raj Chovatiya, MD, PhD, who directs the center for eczema and itch in the department of dermatology at Northwestern University, Chicago, noted that despite a higher prevalence of CU among females compared with males, very little is known about how the condition is managed during pregnancy. “This retrospective study shows that most patients continue to utilize CU treatment during pregnancy (primarily second-generation antihistamines), with similar birth outcomes as the general population,” he said. “Interestingly, cesarean rates were higher among mothers with CU, and emergency CU referral was a risk factor for preterm birth. While additional prospective studies are needed, these results suggest that CU patients should be carefully managed, particularly during pregnancy, when treatment should be optimized.”

Dr. Kocatürk reported having received personal fees from Novartis, Ibrahim Etem-Menarini, and Sanofi, outside the submitted work. Many coauthors reported having numerous financial disclosures. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arcutis, Arena, Incyte, Pfizer, Regeneron, and Sanofi Genzyme.

Most patients with chronic urticaria (CU) used treatment during pregnancy, especially with second-generation antihistamines, which appear to be safe regardless of the trimester. In addition, the rates of preterm births and medical problems of newborns in patients with CU are similar to those of the normal population and not linked to treatment used during pregnancy.

Those are the key findings from an analysis of new data from PREG-CU, an international, multicenter study of the Urticaria Centers of Reference and Excellence (UCARE) network. Results from the first PREG-CU analysis published in 2021 found that CU improved in about half of patients with CU during pregnancy. “However, two in five patients reported acute exacerbations of CU especially at the beginning and end of pregnancy,” investigators led by Emek Kocatürk, MD, of the department of dermatology and UCARE at Koç University School of Medicine, Istanbul, wrote in the new study, recently published in the Journal of the European Academy of Dermatology and Venereology.

“In addition, 1 in 10 pregnant CU patients required urticaria emergency care and 1 of 6 had angioedema during pregnancy,” they said. Risk factors for worsening CU during pregnancy, they added, were “mild disease and no angioedema before pregnancy, not taking treatment before pregnancy, chronic inducible urticaria, CU worsening during a previous pregnancy, stress as a driver of exacerbations, and treatment during pregnancy.”
 

Analysis involved 288 pregnant women

To optimize treatment of CU during pregnancy and to better understand how treatment affects pregnancy outcomes, the researchers analyzed 288 pregnancies in 288 women with CU from 13 countries and 21 centers worldwide. Their mean age at pregnancy was 32.1 years, and their mean duration of CU was 84.9 months. Prior to pregnancy, 35.7% of patients rated the severity of their CU symptoms as mild, 34.2% rated it as moderate, and 29.7% rated it as severe.

The researchers found that during pregnancy, 60% of patients used urticaria medication, including standard-dose second-generation H1-antihistamines (35.1%), first-generation H1-antihistamines (7.6%), high-dose second-generation H1-antihistamines (5.6%), and omalizumab (5.6%). The preterm birth rate was 10.2%, which was similar between patients who did and did not receive treatment during pregnancy (11.6% vs. 8.7%, respectively; P = .59).

On multivariate logistic regression, two predictors for preterm birth emerged: giving birth to twins (a 13.3-fold increased risk; P = .016) and emergency referrals for CU (a 4.3-fold increased risk; P =.016). The cesarean delivery rate was 51.3%, and more than 90% of newborns were healthy at birth. There was no link between any patient or disease characteristics or treatments and medical problems at birth.

In other findings, 78.8% of women with CU breastfed their babies. Of the 58 patients who did not breastfeed, 20.7% indicated severe urticaria/angioedema and/or taking medications as the main reason for not breastfeeding.

“Most CU patients use treatment during pregnancy and such treatments, especially second generation H1 antihistamines, seem to be safe during pregnancy regardless of the trimester,” the researchers concluded. “Outcomes of pregnancy in patients with CU were similar compared to the general population and not linked to treatment used during pregnancy. Notably, emergency referral for CU was an independent risk factor for preterm birth,” and the high cesarean delivery rate was “probably linked to comorbidities associated with the disease,” they added. “Overall, these findings suggest that patients should continue their treatments using an individualized dose to provide optimal symptom control.”


 

International guidelines

The authors noted that international guidelines for the management of urticaria published in 2022 suggest that modern second-generation H1-antihistamines should be used for pregnant patients, preferably loratadine with a possible extrapolation to desloratadine, cetirizine, or levocetirizine.

“Similarly, in this population, we found that cetirizine and loratadine were the most commonly used antihistamines, followed by levocetirizine and fexofenadine,” Dr. Kocatürk and colleagues wrote.

“Guidelines also suggest that the use of first-generation H1-antihistamines should be avoided given their sedative effects; but if these are to be given, it would be wise to know that use of first-generation H1-antihistamines immediately before parturition could cause respiratory depression and other adverse effects in the neonate,” they added, noting that chlorpheniramine and diphenhydramine are the first-generation H1-antihistamines with the greatest evidence of safety in pregnancy.

They acknowledged certain limitations of the analysis, including its retrospective design and the fact that there were no data on low birth weight, small for gestational age, or miscarriage rates. In addition, disease activity or severity during pregnancy and after birth were not monitored.

Asked to comment on these results, Raj Chovatiya, MD, PhD, who directs the center for eczema and itch in the department of dermatology at Northwestern University, Chicago, noted that despite a higher prevalence of CU among females compared with males, very little is known about how the condition is managed during pregnancy. “This retrospective study shows that most patients continue to utilize CU treatment during pregnancy (primarily second-generation antihistamines), with similar birth outcomes as the general population,” he said. “Interestingly, cesarean rates were higher among mothers with CU, and emergency CU referral was a risk factor for preterm birth. While additional prospective studies are needed, these results suggest that CU patients should be carefully managed, particularly during pregnancy, when treatment should be optimized.”

Dr. Kocatürk reported having received personal fees from Novartis, Ibrahim Etem-Menarini, and Sanofi, outside the submitted work. Many coauthors reported having numerous financial disclosures. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arcutis, Arena, Incyte, Pfizer, Regeneron, and Sanofi Genzyme.

Most patients with chronic urticaria (CU) used treatment during pregnancy, especially with second-generation antihistamines, which appear to be safe regardless of the trimester. In addition, the rates of preterm births and medical problems of newborns in patients with CU are similar to those of the normal population and not linked to treatment used during pregnancy.

Those are the key findings from an analysis of new data from PREG-CU, an international, multicenter study of the Urticaria Centers of Reference and Excellence (UCARE) network. Results from the first PREG-CU analysis published in 2021 found that CU improved in about half of patients with CU during pregnancy. “However, two in five patients reported acute exacerbations of CU especially at the beginning and end of pregnancy,” investigators led by Emek Kocatürk, MD, of the department of dermatology and UCARE at Koç University School of Medicine, Istanbul, wrote in the new study, recently published in the Journal of the European Academy of Dermatology and Venereology.

“In addition, 1 in 10 pregnant CU patients required urticaria emergency care and 1 of 6 had angioedema during pregnancy,” they said. Risk factors for worsening CU during pregnancy, they added, were “mild disease and no angioedema before pregnancy, not taking treatment before pregnancy, chronic inducible urticaria, CU worsening during a previous pregnancy, stress as a driver of exacerbations, and treatment during pregnancy.”
 

Analysis involved 288 pregnant women

To optimize treatment of CU during pregnancy and to better understand how treatment affects pregnancy outcomes, the researchers analyzed 288 pregnancies in 288 women with CU from 13 countries and 21 centers worldwide. Their mean age at pregnancy was 32.1 years, and their mean duration of CU was 84.9 months. Prior to pregnancy, 35.7% of patients rated the severity of their CU symptoms as mild, 34.2% rated it as moderate, and 29.7% rated it as severe.

The researchers found that during pregnancy, 60% of patients used urticaria medication, including standard-dose second-generation H1-antihistamines (35.1%), first-generation H1-antihistamines (7.6%), high-dose second-generation H1-antihistamines (5.6%), and omalizumab (5.6%). The preterm birth rate was 10.2%, which was similar between patients who did and did not receive treatment during pregnancy (11.6% vs. 8.7%, respectively; P = .59).

On multivariate logistic regression, two predictors for preterm birth emerged: giving birth to twins (a 13.3-fold increased risk; P = .016) and emergency referrals for CU (a 4.3-fold increased risk; P =.016). The cesarean delivery rate was 51.3%, and more than 90% of newborns were healthy at birth. There was no link between any patient or disease characteristics or treatments and medical problems at birth.

In other findings, 78.8% of women with CU breastfed their babies. Of the 58 patients who did not breastfeed, 20.7% indicated severe urticaria/angioedema and/or taking medications as the main reason for not breastfeeding.

“Most CU patients use treatment during pregnancy and such treatments, especially second generation H1 antihistamines, seem to be safe during pregnancy regardless of the trimester,” the researchers concluded. “Outcomes of pregnancy in patients with CU were similar compared to the general population and not linked to treatment used during pregnancy. Notably, emergency referral for CU was an independent risk factor for preterm birth,” and the high cesarean delivery rate was “probably linked to comorbidities associated with the disease,” they added. “Overall, these findings suggest that patients should continue their treatments using an individualized dose to provide optimal symptom control.”


 

International guidelines

The authors noted that international guidelines for the management of urticaria published in 2022 suggest that modern second-generation H1-antihistamines should be used for pregnant patients, preferably loratadine with a possible extrapolation to desloratadine, cetirizine, or levocetirizine.

“Similarly, in this population, we found that cetirizine and loratadine were the most commonly used antihistamines, followed by levocetirizine and fexofenadine,” Dr. Kocatürk and colleagues wrote.

“Guidelines also suggest that the use of first-generation H1-antihistamines should be avoided given their sedative effects; but if these are to be given, it would be wise to know that use of first-generation H1-antihistamines immediately before parturition could cause respiratory depression and other adverse effects in the neonate,” they added, noting that chlorpheniramine and diphenhydramine are the first-generation H1-antihistamines with the greatest evidence of safety in pregnancy.

They acknowledged certain limitations of the analysis, including its retrospective design and the fact that there were no data on low birth weight, small for gestational age, or miscarriage rates. In addition, disease activity or severity during pregnancy and after birth were not monitored.

Asked to comment on these results, Raj Chovatiya, MD, PhD, who directs the center for eczema and itch in the department of dermatology at Northwestern University, Chicago, noted that despite a higher prevalence of CU among females compared with males, very little is known about how the condition is managed during pregnancy. “This retrospective study shows that most patients continue to utilize CU treatment during pregnancy (primarily second-generation antihistamines), with similar birth outcomes as the general population,” he said. “Interestingly, cesarean rates were higher among mothers with CU, and emergency CU referral was a risk factor for preterm birth. While additional prospective studies are needed, these results suggest that CU patients should be carefully managed, particularly during pregnancy, when treatment should be optimized.”

Dr. Kocatürk reported having received personal fees from Novartis, Ibrahim Etem-Menarini, and Sanofi, outside the submitted work. Many coauthors reported having numerous financial disclosures. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arcutis, Arena, Incyte, Pfizer, Regeneron, and Sanofi Genzyme.

DENVER – Simultaneous use of high intensity focused electromagnetic field (HIFEM) and radiofrequency (RF) was safe and effective for muscle toning and fat reduction in the upper arm area, according to results from a study that analyzed results with MRI and other measures at two dermatology practices.

Simultaneous use of HIFEM and RF has been shown to be safe and effective “for fat reduction and muscle toning in various body parts,” lead study author Carolyn Jacob, MD, founder and director of Chicago Cosmetic Surgery and Dermatology, wrote in an abstract presented at the annual meeting of the American Society for Dermatologic Surgery. This study investigated the effect of the HIFEM and RF procedure on muscle toning and adipose tissue in the upper arms.

In what Dr. Jacob described as the first study of its kind because magnetic resonance imaging (MRI) was used to evaluate results, she and her coauthors enrolled 34 patients aged 23-72 years at two centers who had a BMI in the range of 18.5-33.9 kg/m². The patients underwent four 30-minute bilateral procedures over the upper arms spaced 1 week apart with the Emsculpt NEO (BTL Aesthetics), which simultaneously delivers HIFEM and RF therapy.

NEO small sized applicators were used, which at the time of the study were under investigation but have since been cleared for use with the device. According to the manufacturer’s website, Emsculpt NEO is indicated for noninvasive lipolysis of the abdomen and thighs and reduction in the circumference of the abdomen and thighs in patients with skin types I-VI; and for noninvasive lipolysis of the upper arms “limited to skin types II and III and BMI 30 or under.”

The investigators measured changes in fat and triceps muscle tissue via MRI at baseline, 1-month, and 3-month follow-up visits. They also obtained digital photographs, administered patient questionnaires regarding comfort and satisfaction, and monitored safety of the treatments.

Of the 28 patients who completed their 1-month follow-up visit, analysis of MRI images showed a 22.3% average decrease in fat tissue from baseline MRIs (a decrease of 4.0 ± 1.2 mm; P < .01) and a 21.5% average increase in muscle mass (an increase of 8.2 ± 2.3 mm; P < .001). For the 25 patients who completed their 3-month follow-up visit, analysis of MRI images showed a 25.5% average decrease in fat tissue (a decrease of 4.9 ± 1.5 mm; P < .01) and a 23.9% average increase in muscle mass (an increase of 8.9 ± 2.0 mm; P < .001).

The analysis of questionnaires revealed high patient satisfaction with the results (87.1%), high comfort during the treatment (91.2%), and a low Visual Analogue Scale (VAS) score (1.6 ± 2.0) used to evaluate pain.

“This study shows that HIFEM and RF consistently increases muscle and decreases fat,” Dr. Jacob said in an interview. “It’s the only study on the triceps showing MRI evidence of fat loss with a nonsurgical body shaping device.”

She characterized the learning curve for the Emsculpt NEO as “small, as the previous Emsculpt small applicators have a similar fit.”

Pooja Sodha, MD, director of the center for laser and cosmetic dermatology at George Washington University, Washington, who was asked to comment on the study, said that the combination of radiofrequency energy and high-intensity focused electromagnetic technology triggers heat-induced damage of adipose tissue and muscle strengthening, respectively, to improve overall appearance and tone.

“Simultaneous delivery is the key here, and the real technological superhero, allowing us to take advantage of the synergistic effects of the muscle contractions and the tissue heating,” Dr. Sodha told this news organization. “Earlier this year, we saw published data on success with abdominal contouring with similar fat reduction and muscle enhancement as reported in this study, and these results persisted at 6 months,” with some declines noted at that time, she said.

“It is very encouraging and exciting to have similar effectiveness and safety for the arms, with such high satisfaction and comfort,” she added.

Dr. Jacob disclosed that she has conducted research studies for BTL Aesthetics since 2017 and is a member of the company’s advisory board. Dr. Sodha reported having no financial disclosures.

DENVER – Simultaneous use of high intensity focused electromagnetic field (HIFEM) and radiofrequency (RF) was safe and effective for muscle toning and fat reduction in the upper arm area, according to results from a study that analyzed results with MRI and other measures at two dermatology practices.

Simultaneous use of HIFEM and RF has been shown to be safe and effective “for fat reduction and muscle toning in various body parts,” lead study author Carolyn Jacob, MD, founder and director of Chicago Cosmetic Surgery and Dermatology, wrote in an abstract presented at the annual meeting of the American Society for Dermatologic Surgery. This study investigated the effect of the HIFEM and RF procedure on muscle toning and adipose tissue in the upper arms.

In what Dr. Jacob described as the first study of its kind because magnetic resonance imaging (MRI) was used to evaluate results, she and her coauthors enrolled 34 patients aged 23-72 years at two centers who had a BMI in the range of 18.5-33.9 kg/m². The patients underwent four 30-minute bilateral procedures over the upper arms spaced 1 week apart with the Emsculpt NEO (BTL Aesthetics), which simultaneously delivers HIFEM and RF therapy.

NEO small sized applicators were used, which at the time of the study were under investigation but have since been cleared for use with the device. According to the manufacturer’s website, Emsculpt NEO is indicated for noninvasive lipolysis of the abdomen and thighs and reduction in the circumference of the abdomen and thighs in patients with skin types I-VI; and for noninvasive lipolysis of the upper arms “limited to skin types II and III and BMI 30 or under.”

The investigators measured changes in fat and triceps muscle tissue via MRI at baseline, 1-month, and 3-month follow-up visits. They also obtained digital photographs, administered patient questionnaires regarding comfort and satisfaction, and monitored safety of the treatments.

Of the 28 patients who completed their 1-month follow-up visit, analysis of MRI images showed a 22.3% average decrease in fat tissue from baseline MRIs (a decrease of 4.0 ± 1.2 mm; P < .01) and a 21.5% average increase in muscle mass (an increase of 8.2 ± 2.3 mm; P < .001). For the 25 patients who completed their 3-month follow-up visit, analysis of MRI images showed a 25.5% average decrease in fat tissue (a decrease of 4.9 ± 1.5 mm; P < .01) and a 23.9% average increase in muscle mass (an increase of 8.9 ± 2.0 mm; P < .001).

The analysis of questionnaires revealed high patient satisfaction with the results (87.1%), high comfort during the treatment (91.2%), and a low Visual Analogue Scale (VAS) score (1.6 ± 2.0) used to evaluate pain.

“This study shows that HIFEM and RF consistently increases muscle and decreases fat,” Dr. Jacob said in an interview. “It’s the only study on the triceps showing MRI evidence of fat loss with a nonsurgical body shaping device.”

She characterized the learning curve for the Emsculpt NEO as “small, as the previous Emsculpt small applicators have a similar fit.”

Pooja Sodha, MD, director of the center for laser and cosmetic dermatology at George Washington University, Washington, who was asked to comment on the study, said that the combination of radiofrequency energy and high-intensity focused electromagnetic technology triggers heat-induced damage of adipose tissue and muscle strengthening, respectively, to improve overall appearance and tone.

“Simultaneous delivery is the key here, and the real technological superhero, allowing us to take advantage of the synergistic effects of the muscle contractions and the tissue heating,” Dr. Sodha told this news organization. “Earlier this year, we saw published data on success with abdominal contouring with similar fat reduction and muscle enhancement as reported in this study, and these results persisted at 6 months,” with some declines noted at that time, she said.

“It is very encouraging and exciting to have similar effectiveness and safety for the arms, with such high satisfaction and comfort,” she added.

Dr. Jacob disclosed that she has conducted research studies for BTL Aesthetics since 2017 and is a member of the company’s advisory board. Dr. Sodha reported having no financial disclosures.

DENVER – Simultaneous use of high intensity focused electromagnetic field (HIFEM) and radiofrequency (RF) was safe and effective for muscle toning and fat reduction in the upper arm area, according to results from a study that analyzed results with MRI and other measures at two dermatology practices.

Simultaneous use of HIFEM and RF has been shown to be safe and effective “for fat reduction and muscle toning in various body parts,” lead study author Carolyn Jacob, MD, founder and director of Chicago Cosmetic Surgery and Dermatology, wrote in an abstract presented at the annual meeting of the American Society for Dermatologic Surgery. This study investigated the effect of the HIFEM and RF procedure on muscle toning and adipose tissue in the upper arms.

In what Dr. Jacob described as the first study of its kind because magnetic resonance imaging (MRI) was used to evaluate results, she and her coauthors enrolled 34 patients aged 23-72 years at two centers who had a BMI in the range of 18.5-33.9 kg/m². The patients underwent four 30-minute bilateral procedures over the upper arms spaced 1 week apart with the Emsculpt NEO (BTL Aesthetics), which simultaneously delivers HIFEM and RF therapy.

NEO small sized applicators were used, which at the time of the study were under investigation but have since been cleared for use with the device. According to the manufacturer’s website, Emsculpt NEO is indicated for noninvasive lipolysis of the abdomen and thighs and reduction in the circumference of the abdomen and thighs in patients with skin types I-VI; and for noninvasive lipolysis of the upper arms “limited to skin types II and III and BMI 30 or under.”

The investigators measured changes in fat and triceps muscle tissue via MRI at baseline, 1-month, and 3-month follow-up visits. They also obtained digital photographs, administered patient questionnaires regarding comfort and satisfaction, and monitored safety of the treatments.

Of the 28 patients who completed their 1-month follow-up visit, analysis of MRI images showed a 22.3% average decrease in fat tissue from baseline MRIs (a decrease of 4.0 ± 1.2 mm; P < .01) and a 21.5% average increase in muscle mass (an increase of 8.2 ± 2.3 mm; P < .001). For the 25 patients who completed their 3-month follow-up visit, analysis of MRI images showed a 25.5% average decrease in fat tissue (a decrease of 4.9 ± 1.5 mm; P < .01) and a 23.9% average increase in muscle mass (an increase of 8.9 ± 2.0 mm; P < .001).

The analysis of questionnaires revealed high patient satisfaction with the results (87.1%), high comfort during the treatment (91.2%), and a low Visual Analogue Scale (VAS) score (1.6 ± 2.0) used to evaluate pain.

“This study shows that HIFEM and RF consistently increases muscle and decreases fat,” Dr. Jacob said in an interview. “It’s the only study on the triceps showing MRI evidence of fat loss with a nonsurgical body shaping device.”

She characterized the learning curve for the Emsculpt NEO as “small, as the previous Emsculpt small applicators have a similar fit.”

Pooja Sodha, MD, director of the center for laser and cosmetic dermatology at George Washington University, Washington, who was asked to comment on the study, said that the combination of radiofrequency energy and high-intensity focused electromagnetic technology triggers heat-induced damage of adipose tissue and muscle strengthening, respectively, to improve overall appearance and tone.

“Simultaneous delivery is the key here, and the real technological superhero, allowing us to take advantage of the synergistic effects of the muscle contractions and the tissue heating,” Dr. Sodha told this news organization. “Earlier this year, we saw published data on success with abdominal contouring with similar fat reduction and muscle enhancement as reported in this study, and these results persisted at 6 months,” with some declines noted at that time, she said.

“It is very encouraging and exciting to have similar effectiveness and safety for the arms, with such high satisfaction and comfort,” she added.

Dr. Jacob disclosed that she has conducted research studies for BTL Aesthetics since 2017 and is a member of the company’s advisory board. Dr. Sodha reported having no financial disclosures.

DENVER – Successful treatment of superficial and nodular basal cell cancers can be achieved using apoptosis induced by controlled hyperthermia, preliminary results from an ongoing study suggest.

At the annual meeting of the American Society for Dermatologic Surgery, Christopher Zachary, MD, and colleagues described a novel, noninvasive standardized controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular basal cell cancers (BCCs). “There’s considerable interest on the part of the public in having CHAMP treatment for their BCCs,” Dr. Zachary, professor and chair emeritus, University of California, Irvine, told this news organization in advance of the meeting.

In both study arms, the majority of patients enrolled to date have been found to be free of tumor at 3 months by clinical and OCT examination. “The study is ongoing, but the current numbers indicate that 9 out of 10 superficial and nodular BCCs are free of tumor at 3-12 months after the last treatment,” Dr. Zachary said. The standard-treatment arm, where tissue was treated to a gray color with tissue contraction, generally resulted in more blistering and tissue necrosis with prolonged healing, compared with the Low and Slow–controlled hyperthermia arm. BCC lesions treated in the controlled hyperthermia arm had a lilac gray color with “a surprising increase” in the Doppler blood flow rate, compared with those in the standard-treatment arm, he noted.

“Blood flow following the standard technique is dramatically reduced immediately post treatment, which accounts in part for the frequent ulceration and slow healing in that group,” Dr. Zachary said.

He acknowledged certain limitations of the study, including its relatively small sample size and the fact that the optimal treatment parameters of the Low and Slow technique have yet to be realized. “It could be that we will achieve better results at 50º C for 70 seconds or similar,” he said. “While this technique will not in any way reduce the great benefits of Mohs surgery for complex BCCs, it will benefit those with simpler superficial and nodular BCCs, particularly in those who are not good surgical candidates.”

As an aside, Dr. Zachary supports the increased use of OCT scanners to improve the ability to diagnose and assess the lateral and deep margins of skin cancers. “I think that all dermatology residents should understand how to use these devices,” he said. “I’m convinced they are going to be useful in their clinical practice in the future.”

Keith L. Duffy, MD, who was asked to comment on the work, said that the study demonstrates novel ways to use existing and developing technologies in dermatology and highlights the intersection of aesthetic, surgical, and medical dermatology. “CHAMP is promising as shown by the data in the abstract and I am eager to see the final results of the study with an eye toward final cure rate and cosmesis,” said Dr. Duffy, associate professor of dermatology at the University of Utah, Salt Lake City.

“In my estimation, this technology will need to prove to be superior in one or both of these parameters in order to be considered a first- or second-line therapy,” he added. “My practice for these types of basal cell carcinomas is a simple one pass of curettage with aluminum chloride or pressure for hemostasis. The healing is fast, the cosmesis is excellent, and the cure rate is more than 90% for this simple in-office destruction. However, for those with access to this technology and proficiency with its use, CHAMP may become a viable alternative to our existing destructive methods. I look forward to seeing the published results of this multicenter trial.”

This study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Neither Dr. Zachary nor Dr. Duffy reported having relevant disclosures.
 

DENVER – Successful treatment of superficial and nodular basal cell cancers can be achieved using apoptosis induced by controlled hyperthermia, preliminary results from an ongoing study suggest.

At the annual meeting of the American Society for Dermatologic Surgery, Christopher Zachary, MD, and colleagues described a novel, noninvasive standardized controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular basal cell cancers (BCCs). “There’s considerable interest on the part of the public in having CHAMP treatment for their BCCs,” Dr. Zachary, professor and chair emeritus, University of California, Irvine, told this news organization in advance of the meeting.

In both study arms, the majority of patients enrolled to date have been found to be free of tumor at 3 months by clinical and OCT examination. “The study is ongoing, but the current numbers indicate that 9 out of 10 superficial and nodular BCCs are free of tumor at 3-12 months after the last treatment,” Dr. Zachary said. The standard-treatment arm, where tissue was treated to a gray color with tissue contraction, generally resulted in more blistering and tissue necrosis with prolonged healing, compared with the Low and Slow–controlled hyperthermia arm. BCC lesions treated in the controlled hyperthermia arm had a lilac gray color with “a surprising increase” in the Doppler blood flow rate, compared with those in the standard-treatment arm, he noted.

“Blood flow following the standard technique is dramatically reduced immediately post treatment, which accounts in part for the frequent ulceration and slow healing in that group,” Dr. Zachary said.

He acknowledged certain limitations of the study, including its relatively small sample size and the fact that the optimal treatment parameters of the Low and Slow technique have yet to be realized. “It could be that we will achieve better results at 50º C for 70 seconds or similar,” he said. “While this technique will not in any way reduce the great benefits of Mohs surgery for complex BCCs, it will benefit those with simpler superficial and nodular BCCs, particularly in those who are not good surgical candidates.”

As an aside, Dr. Zachary supports the increased use of OCT scanners to improve the ability to diagnose and assess the lateral and deep margins of skin cancers. “I think that all dermatology residents should understand how to use these devices,” he said. “I’m convinced they are going to be useful in their clinical practice in the future.”

Keith L. Duffy, MD, who was asked to comment on the work, said that the study demonstrates novel ways to use existing and developing technologies in dermatology and highlights the intersection of aesthetic, surgical, and medical dermatology. “CHAMP is promising as shown by the data in the abstract and I am eager to see the final results of the study with an eye toward final cure rate and cosmesis,” said Dr. Duffy, associate professor of dermatology at the University of Utah, Salt Lake City.

“In my estimation, this technology will need to prove to be superior in one or both of these parameters in order to be considered a first- or second-line therapy,” he added. “My practice for these types of basal cell carcinomas is a simple one pass of curettage with aluminum chloride or pressure for hemostasis. The healing is fast, the cosmesis is excellent, and the cure rate is more than 90% for this simple in-office destruction. However, for those with access to this technology and proficiency with its use, CHAMP may become a viable alternative to our existing destructive methods. I look forward to seeing the published results of this multicenter trial.”

This study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Neither Dr. Zachary nor Dr. Duffy reported having relevant disclosures.
 

DENVER – Successful treatment of superficial and nodular basal cell cancers can be achieved using apoptosis induced by controlled hyperthermia, preliminary results from an ongoing study suggest.

At the annual meeting of the American Society for Dermatologic Surgery, Christopher Zachary, MD, and colleagues described a novel, noninvasive standardized controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular basal cell cancers (BCCs). “There’s considerable interest on the part of the public in having CHAMP treatment for their BCCs,” Dr. Zachary, professor and chair emeritus, University of California, Irvine, told this news organization in advance of the meeting.

In both study arms, the majority of patients enrolled to date have been found to be free of tumor at 3 months by clinical and OCT examination. “The study is ongoing, but the current numbers indicate that 9 out of 10 superficial and nodular BCCs are free of tumor at 3-12 months after the last treatment,” Dr. Zachary said. The standard-treatment arm, where tissue was treated to a gray color with tissue contraction, generally resulted in more blistering and tissue necrosis with prolonged healing, compared with the Low and Slow–controlled hyperthermia arm. BCC lesions treated in the controlled hyperthermia arm had a lilac gray color with “a surprising increase” in the Doppler blood flow rate, compared with those in the standard-treatment arm, he noted.

“Blood flow following the standard technique is dramatically reduced immediately post treatment, which accounts in part for the frequent ulceration and slow healing in that group,” Dr. Zachary said.

He acknowledged certain limitations of the study, including its relatively small sample size and the fact that the optimal treatment parameters of the Low and Slow technique have yet to be realized. “It could be that we will achieve better results at 50º C for 70 seconds or similar,” he said. “While this technique will not in any way reduce the great benefits of Mohs surgery for complex BCCs, it will benefit those with simpler superficial and nodular BCCs, particularly in those who are not good surgical candidates.”

As an aside, Dr. Zachary supports the increased use of OCT scanners to improve the ability to diagnose and assess the lateral and deep margins of skin cancers. “I think that all dermatology residents should understand how to use these devices,” he said. “I’m convinced they are going to be useful in their clinical practice in the future.”

Keith L. Duffy, MD, who was asked to comment on the work, said that the study demonstrates novel ways to use existing and developing technologies in dermatology and highlights the intersection of aesthetic, surgical, and medical dermatology. “CHAMP is promising as shown by the data in the abstract and I am eager to see the final results of the study with an eye toward final cure rate and cosmesis,” said Dr. Duffy, associate professor of dermatology at the University of Utah, Salt Lake City.

“In my estimation, this technology will need to prove to be superior in one or both of these parameters in order to be considered a first- or second-line therapy,” he added. “My practice for these types of basal cell carcinomas is a simple one pass of curettage with aluminum chloride or pressure for hemostasis. The healing is fast, the cosmesis is excellent, and the cure rate is more than 90% for this simple in-office destruction. However, for those with access to this technology and proficiency with its use, CHAMP may become a viable alternative to our existing destructive methods. I look forward to seeing the published results of this multicenter trial.”

This study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Neither Dr. Zachary nor Dr. Duffy reported having relevant disclosures.
 

DENVER – Highly purified liquid injectable silicone is a safe and effective permanent treatment for acne scarring in all skin types, including darker skin types, results from a recent study showed.

“Acne is pervasive, and acne scarring disproportionately affects darker skin types,” lead study author Nicole Salame, MD, told this news organization in advance of the annual meeting of the American Society for Dermatologic Surgery, where she presented the results of the study. “Treatment of acne scarring in darker skin is also particularly challenging since resurfacing can be problematic. Numerous treatment options exist but vary in effectiveness, sustainability, and side-effect profile, especially for patients with darker skin.”

Highly purified liquid injectable silicone (also known as LIS) is approved by the Food and Drug Administration for treating intraocular tamponade of retinal detachment, and has been used off label for skin augmentation. A 2005 study of LIS for five patients with acne scarring, with up to 30 years of follow-up, showed efficacy and preservation of product without complications for depressed, broad-based acne scars .

“Use of LIS as a permanent treatment for acne scarring in darker skin types has yet to be evaluated,” said Dr. Salame, a 4th-year dermatology resident at Emory University, Atlanta. “Our study is the first to retrospectively evaluate the safety and efficacy of highly purified LIS for the treatment of acne scars in all skin types.”

Dr. Salame and coauthor Harold J. Brody, MD, evaluated the charts of 96 patients with a mean age of 51 years who received highly purified LIS for the treatment of acne scars at Dr. Brody’s Atlanta-based private dermatology practice between July 2010 and March 2021. Of the 96 patients, 31 had darker skin types (20 were Fitzpatrick skin type IV and 11 were Fitzpatrick skin type V). Dr. Brody performed all treatments: a total of 206 in the 96 patients.

The average time of follow-up was 6.31 years; 19 patients had a follow-up of 1-3 years, 25 had a follow-up of 3-5 years, and 52 had a follow-up of greater than 5 years. The researchers did not observe any complications along the course of the patients’ treatments, and no patients reported complications or dissatisfaction with treatment.

“Among the most impressive findings of our study was the permanence of effectiveness of LIS for acne scarring in patients who had treatment over a decade before,” Dr. Salame said. “Our longest follow up was 12 years. These patients continued to show improvement in their acne scarring years after treatment with LIS, even as they lost collagen and volume in their face with advancing age.”

In addition, she said, none of the patients experienced complications of granulomatous reactions, migration, or extrusion of product, which were previously documented with the use of macrodroplet injectable silicone techniques. “This is likely due to the consistent use of the microdroplet injection technique in our study – less than 0.01 cc per injection at minimum 6- to 8-week intervals or more,” Dr. Salame said.

Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment on the study, said that the findings “show safety and durability of highly purified microdroplet liquid silicone to treat acne scars. The numbers of patients reviewed are small and selective (one highly skilled dermatologist), but with the right material (highly purified liquid silicone) and in a qualified and experienced physician’s hand, this treatment seems like a great option.”

Dr. Salame acknowledged certain limitations of the study, including its single-center, retrospective design. “Future prospective studies with larger patient populations of all skin types recruited from multiple centers may be needed,” she said.

The researchers reported having no relevant conflicts of interest or funding sources to disclose. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

DENVER – Highly purified liquid injectable silicone is a safe and effective permanent treatment for acne scarring in all skin types, including darker skin types, results from a recent study showed.

“Acne is pervasive, and acne scarring disproportionately affects darker skin types,” lead study author Nicole Salame, MD, told this news organization in advance of the annual meeting of the American Society for Dermatologic Surgery, where she presented the results of the study. “Treatment of acne scarring in darker skin is also particularly challenging since resurfacing can be problematic. Numerous treatment options exist but vary in effectiveness, sustainability, and side-effect profile, especially for patients with darker skin.”

Highly purified liquid injectable silicone (also known as LIS) is approved by the Food and Drug Administration for treating intraocular tamponade of retinal detachment, and has been used off label for skin augmentation. A 2005 study of LIS for five patients with acne scarring, with up to 30 years of follow-up, showed efficacy and preservation of product without complications for depressed, broad-based acne scars .

“Use of LIS as a permanent treatment for acne scarring in darker skin types has yet to be evaluated,” said Dr. Salame, a 4th-year dermatology resident at Emory University, Atlanta. “Our study is the first to retrospectively evaluate the safety and efficacy of highly purified LIS for the treatment of acne scars in all skin types.”

Dr. Salame and coauthor Harold J. Brody, MD, evaluated the charts of 96 patients with a mean age of 51 years who received highly purified LIS for the treatment of acne scars at Dr. Brody’s Atlanta-based private dermatology practice between July 2010 and March 2021. Of the 96 patients, 31 had darker skin types (20 were Fitzpatrick skin type IV and 11 were Fitzpatrick skin type V). Dr. Brody performed all treatments: a total of 206 in the 96 patients.

The average time of follow-up was 6.31 years; 19 patients had a follow-up of 1-3 years, 25 had a follow-up of 3-5 years, and 52 had a follow-up of greater than 5 years. The researchers did not observe any complications along the course of the patients’ treatments, and no patients reported complications or dissatisfaction with treatment.

“Among the most impressive findings of our study was the permanence of effectiveness of LIS for acne scarring in patients who had treatment over a decade before,” Dr. Salame said. “Our longest follow up was 12 years. These patients continued to show improvement in their acne scarring years after treatment with LIS, even as they lost collagen and volume in their face with advancing age.”

In addition, she said, none of the patients experienced complications of granulomatous reactions, migration, or extrusion of product, which were previously documented with the use of macrodroplet injectable silicone techniques. “This is likely due to the consistent use of the microdroplet injection technique in our study – less than 0.01 cc per injection at minimum 6- to 8-week intervals or more,” Dr. Salame said.

Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment on the study, said that the findings “show safety and durability of highly purified microdroplet liquid silicone to treat acne scars. The numbers of patients reviewed are small and selective (one highly skilled dermatologist), but with the right material (highly purified liquid silicone) and in a qualified and experienced physician’s hand, this treatment seems like a great option.”

Dr. Salame acknowledged certain limitations of the study, including its single-center, retrospective design. “Future prospective studies with larger patient populations of all skin types recruited from multiple centers may be needed,” she said.

The researchers reported having no relevant conflicts of interest or funding sources to disclose. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

DENVER – Highly purified liquid injectable silicone is a safe and effective permanent treatment for acne scarring in all skin types, including darker skin types, results from a recent study showed.

“Acne is pervasive, and acne scarring disproportionately affects darker skin types,” lead study author Nicole Salame, MD, told this news organization in advance of the annual meeting of the American Society for Dermatologic Surgery, where she presented the results of the study. “Treatment of acne scarring in darker skin is also particularly challenging since resurfacing can be problematic. Numerous treatment options exist but vary in effectiveness, sustainability, and side-effect profile, especially for patients with darker skin.”

Highly purified liquid injectable silicone (also known as LIS) is approved by the Food and Drug Administration for treating intraocular tamponade of retinal detachment, and has been used off label for skin augmentation. A 2005 study of LIS for five patients with acne scarring, with up to 30 years of follow-up, showed efficacy and preservation of product without complications for depressed, broad-based acne scars .

“Use of LIS as a permanent treatment for acne scarring in darker skin types has yet to be evaluated,” said Dr. Salame, a 4th-year dermatology resident at Emory University, Atlanta. “Our study is the first to retrospectively evaluate the safety and efficacy of highly purified LIS for the treatment of acne scars in all skin types.”

Dr. Salame and coauthor Harold J. Brody, MD, evaluated the charts of 96 patients with a mean age of 51 years who received highly purified LIS for the treatment of acne scars at Dr. Brody’s Atlanta-based private dermatology practice between July 2010 and March 2021. Of the 96 patients, 31 had darker skin types (20 were Fitzpatrick skin type IV and 11 were Fitzpatrick skin type V). Dr. Brody performed all treatments: a total of 206 in the 96 patients.

The average time of follow-up was 6.31 years; 19 patients had a follow-up of 1-3 years, 25 had a follow-up of 3-5 years, and 52 had a follow-up of greater than 5 years. The researchers did not observe any complications along the course of the patients’ treatments, and no patients reported complications or dissatisfaction with treatment.

“Among the most impressive findings of our study was the permanence of effectiveness of LIS for acne scarring in patients who had treatment over a decade before,” Dr. Salame said. “Our longest follow up was 12 years. These patients continued to show improvement in their acne scarring years after treatment with LIS, even as they lost collagen and volume in their face with advancing age.”

In addition, she said, none of the patients experienced complications of granulomatous reactions, migration, or extrusion of product, which were previously documented with the use of macrodroplet injectable silicone techniques. “This is likely due to the consistent use of the microdroplet injection technique in our study – less than 0.01 cc per injection at minimum 6- to 8-week intervals or more,” Dr. Salame said.

Lawrence J. Green, MD, of the department of dermatology at George Washington University, Washington, who was asked to comment on the study, said that the findings “show safety and durability of highly purified microdroplet liquid silicone to treat acne scars. The numbers of patients reviewed are small and selective (one highly skilled dermatologist), but with the right material (highly purified liquid silicone) and in a qualified and experienced physician’s hand, this treatment seems like a great option.”

Dr. Salame acknowledged certain limitations of the study, including its single-center, retrospective design. “Future prospective studies with larger patient populations of all skin types recruited from multiple centers may be needed,” she said.

The researchers reported having no relevant conflicts of interest or funding sources to disclose. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

DENVER – Vision loss is a rare but potentially devastating complication of platelet-rich plasma (PRP) injections, results from a systematic review showed. None of the cases involved scalp injections.

“Both soft tissue fillers and [PRP] are common injection-type treatments that dermatologists perform on the head and neck area,” lead study author Sean Wu, MD, said in an interview in advance of the annual meeting of the American Society for Dermatologic Surgery, where he presented the results during an oral abstract session. “Fillers are usually used to replace volume and fill in lines while PRP is usually used for skin rejuvenation and certain forms of hair loss. We know that fillers may rarely cause blindness if accidentally injected into a facial artery.”

chee gin tan/Getty Images

Certain facial areas such as the glabella, nose, and forehead are considered high risk for blindness with filler injections. But whether PRP injections in those areas may also result in blindness is not yet known, so Dr. Wu and his colleagues, Xu He, MD, and Robert Weiss, MD, at the Maryland Laser, Skin, and Vein Institute in Hunt Valley, Md., performed what is believed to be the first systematic review of the topic. In January 2022 they searched the PubMed database, which yielded 224 articles from which they selected four for full review. The results were recently published in Dermatologic Surgery.

Collectively, the four articles reported a total of seven patients with unilateral vision loss or impairment following PRP injection. They ranged in age from 41 to 63 years. Skin rejuvenation was the indication for PRP injection in six patients and temporomandibular joint (TMJ) disorder in one. Three of the cases occurred in Venezuela while one each occurred in the United States, the United Kingdom, and Malaysia. All patients had signs of arterial occlusion or ischemia on retinal examination or imaging.

Dr. Wu and colleagues found that the glabella was the most common site of injection associated with vision loss (five cases), followed by the forehead (two cases), and one case each in the lateral canthus, nasolabial fold, and the TMJ. In all but two cases, vision loss occurred immediately after injection. (The number of injections exceeded seven because two patients received PRP in more than one site.)

Associated symptoms included ocular pain, fullness, eyelid ptosis, headache, nausea, vomiting, dizziness, tinnitus, and urinary urgency. At their initial ophthalmology evaluation, six patients had no light perception in the affected eye. Only one patient reported recovery of visual acuity at 3 months but with residual deficits on eye exam. This person had been evaluated and treated by an ophthalmologist within 3 hours of symptom onset.

“The other cases reported complete blindness in one eye,” Dr. Wu said. “There is no reversing agent for PRP, unlike for many fillers, so there is no clear-cut solution for this issue.”

Based on the results of the systematic review, Dr. Wu concluded that blindness is a rare complication of PRP. “We should take the same precautions when injecting PRP on the face as we do when injecting fillers,” he advised. “This may include not injecting in high-risk areas and aspirating prior to injection to make sure we are not accidentally injecting into an artery.”

It was “notable,” he added, that no cases of blindness occurred following scalp injections of PRP for hair loss, indicating “that this use of PRP is likely very safe from a vision loss standpoint.”

Dr. Wu acknowledged certain imitations of the analysis, including the low quality of some case reports/series. “There is a notable lack of detail on the PRP injection technique, as the authors of the case reports were generally not the PRP injectors themselves,” he said. “There was also no attempt at treatment in a series of four cases.”

Asked to comment on the review, Terrence Keaney, MD, founder and director of SkinDC, in Arlington, Va., said that the analysis underscores the importance of considering blindness as a possible side effect when injecting PRP into the face. “Using techniques that can minimize intravascular injections including the use of cannulas, aspiration, and larger needle size may help reduce this rare side effect,” said Dr. Keaney, a clinical associate professor of dermatology at George Washington University, Washington.

DENVER – Vision loss is a rare but potentially devastating complication of platelet-rich plasma (PRP) injections, results from a systematic review showed. None of the cases involved scalp injections.

“Both soft tissue fillers and [PRP] are common injection-type treatments that dermatologists perform on the head and neck area,” lead study author Sean Wu, MD, said in an interview in advance of the annual meeting of the American Society for Dermatologic Surgery, where he presented the results during an oral abstract session. “Fillers are usually used to replace volume and fill in lines while PRP is usually used for skin rejuvenation and certain forms of hair loss. We know that fillers may rarely cause blindness if accidentally injected into a facial artery.”

chee gin tan/Getty Images

Certain facial areas such as the glabella, nose, and forehead are considered high risk for blindness with filler injections. But whether PRP injections in those areas may also result in blindness is not yet known, so Dr. Wu and his colleagues, Xu He, MD, and Robert Weiss, MD, at the Maryland Laser, Skin, and Vein Institute in Hunt Valley, Md., performed what is believed to be the first systematic review of the topic. In January 2022 they searched the PubMed database, which yielded 224 articles from which they selected four for full review. The results were recently published in Dermatologic Surgery.

Collectively, the four articles reported a total of seven patients with unilateral vision loss or impairment following PRP injection. They ranged in age from 41 to 63 years. Skin rejuvenation was the indication for PRP injection in six patients and temporomandibular joint (TMJ) disorder in one. Three of the cases occurred in Venezuela while one each occurred in the United States, the United Kingdom, and Malaysia. All patients had signs of arterial occlusion or ischemia on retinal examination or imaging.

Dr. Wu and colleagues found that the glabella was the most common site of injection associated with vision loss (five cases), followed by the forehead (two cases), and one case each in the lateral canthus, nasolabial fold, and the TMJ. In all but two cases, vision loss occurred immediately after injection. (The number of injections exceeded seven because two patients received PRP in more than one site.)

Associated symptoms included ocular pain, fullness, eyelid ptosis, headache, nausea, vomiting, dizziness, tinnitus, and urinary urgency. At their initial ophthalmology evaluation, six patients had no light perception in the affected eye. Only one patient reported recovery of visual acuity at 3 months but with residual deficits on eye exam. This person had been evaluated and treated by an ophthalmologist within 3 hours of symptom onset.

“The other cases reported complete blindness in one eye,” Dr. Wu said. “There is no reversing agent for PRP, unlike for many fillers, so there is no clear-cut solution for this issue.”

Based on the results of the systematic review, Dr. Wu concluded that blindness is a rare complication of PRP. “We should take the same precautions when injecting PRP on the face as we do when injecting fillers,” he advised. “This may include not injecting in high-risk areas and aspirating prior to injection to make sure we are not accidentally injecting into an artery.”

It was “notable,” he added, that no cases of blindness occurred following scalp injections of PRP for hair loss, indicating “that this use of PRP is likely very safe from a vision loss standpoint.”

Dr. Wu acknowledged certain imitations of the analysis, including the low quality of some case reports/series. “There is a notable lack of detail on the PRP injection technique, as the authors of the case reports were generally not the PRP injectors themselves,” he said. “There was also no attempt at treatment in a series of four cases.”

Asked to comment on the review, Terrence Keaney, MD, founder and director of SkinDC, in Arlington, Va., said that the analysis underscores the importance of considering blindness as a possible side effect when injecting PRP into the face. “Using techniques that can minimize intravascular injections including the use of cannulas, aspiration, and larger needle size may help reduce this rare side effect,” said Dr. Keaney, a clinical associate professor of dermatology at George Washington University, Washington.

DENVER – Vision loss is a rare but potentially devastating complication of platelet-rich plasma (PRP) injections, results from a systematic review showed. None of the cases involved scalp injections.

“Both soft tissue fillers and [PRP] are common injection-type treatments that dermatologists perform on the head and neck area,” lead study author Sean Wu, MD, said in an interview in advance of the annual meeting of the American Society for Dermatologic Surgery, where he presented the results during an oral abstract session. “Fillers are usually used to replace volume and fill in lines while PRP is usually used for skin rejuvenation and certain forms of hair loss. We know that fillers may rarely cause blindness if accidentally injected into a facial artery.”

chee gin tan/Getty Images

Certain facial areas such as the glabella, nose, and forehead are considered high risk for blindness with filler injections. But whether PRP injections in those areas may also result in blindness is not yet known, so Dr. Wu and his colleagues, Xu He, MD, and Robert Weiss, MD, at the Maryland Laser, Skin, and Vein Institute in Hunt Valley, Md., performed what is believed to be the first systematic review of the topic. In January 2022 they searched the PubMed database, which yielded 224 articles from which they selected four for full review. The results were recently published in Dermatologic Surgery.

Collectively, the four articles reported a total of seven patients with unilateral vision loss or impairment following PRP injection. They ranged in age from 41 to 63 years. Skin rejuvenation was the indication for PRP injection in six patients and temporomandibular joint (TMJ) disorder in one. Three of the cases occurred in Venezuela while one each occurred in the United States, the United Kingdom, and Malaysia. All patients had signs of arterial occlusion or ischemia on retinal examination or imaging.

Dr. Wu and colleagues found that the glabella was the most common site of injection associated with vision loss (five cases), followed by the forehead (two cases), and one case each in the lateral canthus, nasolabial fold, and the TMJ. In all but two cases, vision loss occurred immediately after injection. (The number of injections exceeded seven because two patients received PRP in more than one site.)

Associated symptoms included ocular pain, fullness, eyelid ptosis, headache, nausea, vomiting, dizziness, tinnitus, and urinary urgency. At their initial ophthalmology evaluation, six patients had no light perception in the affected eye. Only one patient reported recovery of visual acuity at 3 months but with residual deficits on eye exam. This person had been evaluated and treated by an ophthalmologist within 3 hours of symptom onset.

“The other cases reported complete blindness in one eye,” Dr. Wu said. “There is no reversing agent for PRP, unlike for many fillers, so there is no clear-cut solution for this issue.”

Based on the results of the systematic review, Dr. Wu concluded that blindness is a rare complication of PRP. “We should take the same precautions when injecting PRP on the face as we do when injecting fillers,” he advised. “This may include not injecting in high-risk areas and aspirating prior to injection to make sure we are not accidentally injecting into an artery.”

It was “notable,” he added, that no cases of blindness occurred following scalp injections of PRP for hair loss, indicating “that this use of PRP is likely very safe from a vision loss standpoint.”

Dr. Wu acknowledged certain imitations of the analysis, including the low quality of some case reports/series. “There is a notable lack of detail on the PRP injection technique, as the authors of the case reports were generally not the PRP injectors themselves,” he said. “There was also no attempt at treatment in a series of four cases.”

Asked to comment on the review, Terrence Keaney, MD, founder and director of SkinDC, in Arlington, Va., said that the analysis underscores the importance of considering blindness as a possible side effect when injecting PRP into the face. “Using techniques that can minimize intravascular injections including the use of cannulas, aspiration, and larger needle size may help reduce this rare side effect,” said Dr. Keaney, a clinical associate professor of dermatology at George Washington University, Washington.

The days of strictly classifying rosacea patients as having erythematotelangiectatic, papulopustular, phymatous, or ocular forms of the skin condition are over. At least they should be, according to Julie C. Harper, MD.

“How many people with papules and pustules don’t also have redness?” Dr. Harper, who practices in Birmingham, Ala., said at Medscape Live’s annual Coastal Dermatology Symposium. “If we’re not careful, and we try to classify a person into a subtype of rosacea, we end up treating only part of their rosacea; we don’t treat all of it. We have seen this in the literature,” she added.

“The idea now is to take a phenotypic approach to rosacea. What we mean by that is that you look at the patient, you document every part of rosacea that you see, and you treat according to that,” she continued. “That person with papules and pustules may also have phyma and ocular disease. They may have telangiectasia and persistent background erythema. They may also have flushing.”

Dr. Harper incorporates the mnemonic “STOP” to her visits with rosacea patients.

S stands for: Identify signs and symptoms of the condition. “Listen to the patient for symptoms,” she advised. “We’ve learned to listen to darker skinned patients for what they tell us about erythema, for example, because we may not be able to see it, yet they are experiencing it. They may also have symptomatic burning, itching, and stinging.”

T stands for: Discuss triggers. “Ask patients, ‘what is it that makes your rosacea worse?’ That’s different for everyone,” she said.

O stands for: Agree on a treatment outcome. “Ask, ‘what is it that really bothers you? Are you bothered by the bumps? The redness?’ ” she said.

“The P stands for: Develop a plan that addresses all of that,” she said.

Different treatments for different rosacea symptoms

No one-size-fits-all treatment exists for rosacea. Options that work well for papules and pustules aren’t effective for redness. Similarly, products that work for redness don’t work for telangiectasia.

“Different lesions and signs of rosacea will likely require multiple modes of treatment,” Dr. Harper said. “So, when you evaluate your rosacea patients, if they’re doing great, don’t change their regimen. But if you see somebody who is not well controlled, is there an opportunity for you to come in and add something to that regimen that may make them better? Maybe so.”

Treatment options indicated for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and encapsulated benzoyl peroxide.

Options indicated for persistent background erythema include brimonidine and oxymetazoline, while device-based treatments include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
 

Anti-inflammatory action for pustules and papules

A relatively new product indicated for pustules and papules is minocycline 1.5% foam, the only minocycline that is FDA approved to treat rosacea.

“There is no oral minocycline product approved for rosacea yet,” Dr. Harper said. “There is not a known bacterial pathogen in rosacea. Tetracyclines likely work in rosacea by inhibiting neutrophil chemotaxis, inhibiting MMP and thus KLK-5 and LL-37, inhibiting pro-inflammatory cytokines, downregulating reactive oxygen species, and inhibiting angiogenesis.”

In two 12-week, phase 3 randomized studies of 1,522 patients with moderate to severe rosacea, participants were assigned to receive minocycline 5% foam or a vehicle that contained mineral oil and coconut oil.

At week 12, about 50% of patients who received minocycline 5% foam were clear, compared with about 40% of those in the vehicle arm. Also, the reduction of lesion count was about 63% for patients in the treatment group, compared with a reduction of about 54% in the vehicle arm.

Dr. Harper characterized the 63% reduction as “pretty good, but is it good enough or fast enough? I don’t think so, so even with a great drug like this, I would use something else. You can use two medications sometimes to get people better faster. There’s room to bring in something for that background erythema.”

Minocycline 1.5% foam is colored yellow and may stain fabric. “It contains coconut oil, soybean oil, and light mineral oil,” she said. “Most people prefer to use this at bedtime, but you don’t have to.”

Another treatment option is 5% microencapsulated benzoyl peroxide cream, which is FDA approved for inflammatory lesions of rosacea.

“What’s the mechanism of action? Probably not being antimicrobial,” Dr. Harper said. “I think it’s probably at least in part anti-inflammatory, because we have some data to show that it’s killing Demodex [mites]. If Demodex [are] a trigger of inflammation, and we can lessen Demodex, then we could lessen the inflammatory response after that.”

The drug’s approval was based on data from two positive, identical phase 3 randomized, double-blind, multicenter, 12-week clinical trials that evaluated its safety compared with vehicle in 733 people with inflammatory lesions of rosacea (NCT03564119 and NCT03448939).

At week 12, inflammatory lesions of rosacea were reduced by nearly 70% in both trials among those who received 5% microencapsulated benzoyl peroxide cream, compared with 38%-46% among those who received the vehicle. Also, nearly 50% of subjects in the treatment groups were clear or almost clear at 12 weeks, compared with 38%-46% of those who received the vehicle.

Dr. Harper added that about one-quarter of patients in the treatment group of the trials were clear or almost clear by week 4. “That’s pretty fast,” she said, noting that the product’s microencapsulated shell acts as a fenestrated barrier. “It has little openings, which means that it takes a while for the drug to work itself out,” she said. “I think of it as being like a speed bump for benzoyl peroxide delivery. It has to get through this little maze before it lands on the skin. We think that is what has helped with tolerability.”

Oral sarecycline, a narrow spectrum tetracycline that was FDA approved for acne in 2018, may also benefit rosacea patients. In a 12-week, investigator-blinded pilot study, 72 patients with papulopustular rosacea were assigned to receive sarecycline, while 25 received a multivitamin.

By week 12, 75% of patients in the sarecycline group were clear, compared with 16% of those in the multivitamin group, while the inflammatory lesion counts dropped from baseline by 80% and 60%, respectively. Studies of sarecycline for acne have demonstrated similar rates of vertigo, dizziness, and sunburn to those of placebo.

“There were also low rates of gastrointestinal disturbances,” Dr. Harper said. “That’s important in rosacea, because there is no bacterial pathogen.”

Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speakers bureau for Almirall, EPI, Galderma, Ortho, and Vyne.

Medscape Live and this news organization are owned by the same parent company.

The days of strictly classifying rosacea patients as having erythematotelangiectatic, papulopustular, phymatous, or ocular forms of the skin condition are over. At least they should be, according to Julie C. Harper, MD.

“How many people with papules and pustules don’t also have redness?” Dr. Harper, who practices in Birmingham, Ala., said at Medscape Live’s annual Coastal Dermatology Symposium. “If we’re not careful, and we try to classify a person into a subtype of rosacea, we end up treating only part of their rosacea; we don’t treat all of it. We have seen this in the literature,” she added.

“The idea now is to take a phenotypic approach to rosacea. What we mean by that is that you look at the patient, you document every part of rosacea that you see, and you treat according to that,” she continued. “That person with papules and pustules may also have phyma and ocular disease. They may have telangiectasia and persistent background erythema. They may also have flushing.”

Dr. Harper incorporates the mnemonic “STOP” to her visits with rosacea patients.

S stands for: Identify signs and symptoms of the condition. “Listen to the patient for symptoms,” she advised. “We’ve learned to listen to darker skinned patients for what they tell us about erythema, for example, because we may not be able to see it, yet they are experiencing it. They may also have symptomatic burning, itching, and stinging.”

T stands for: Discuss triggers. “Ask patients, ‘what is it that makes your rosacea worse?’ That’s different for everyone,” she said.

O stands for: Agree on a treatment outcome. “Ask, ‘what is it that really bothers you? Are you bothered by the bumps? The redness?’ ” she said.

“The P stands for: Develop a plan that addresses all of that,” she said.

Different treatments for different rosacea symptoms

No one-size-fits-all treatment exists for rosacea. Options that work well for papules and pustules aren’t effective for redness. Similarly, products that work for redness don’t work for telangiectasia.

“Different lesions and signs of rosacea will likely require multiple modes of treatment,” Dr. Harper said. “So, when you evaluate your rosacea patients, if they’re doing great, don’t change their regimen. But if you see somebody who is not well controlled, is there an opportunity for you to come in and add something to that regimen that may make them better? Maybe so.”

Treatment options indicated for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and encapsulated benzoyl peroxide.

Options indicated for persistent background erythema include brimonidine and oxymetazoline, while device-based treatments include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
 

Anti-inflammatory action for pustules and papules

A relatively new product indicated for pustules and papules is minocycline 1.5% foam, the only minocycline that is FDA approved to treat rosacea.

“There is no oral minocycline product approved for rosacea yet,” Dr. Harper said. “There is not a known bacterial pathogen in rosacea. Tetracyclines likely work in rosacea by inhibiting neutrophil chemotaxis, inhibiting MMP and thus KLK-5 and LL-37, inhibiting pro-inflammatory cytokines, downregulating reactive oxygen species, and inhibiting angiogenesis.”

In two 12-week, phase 3 randomized studies of 1,522 patients with moderate to severe rosacea, participants were assigned to receive minocycline 5% foam or a vehicle that contained mineral oil and coconut oil.

At week 12, about 50% of patients who received minocycline 5% foam were clear, compared with about 40% of those in the vehicle arm. Also, the reduction of lesion count was about 63% for patients in the treatment group, compared with a reduction of about 54% in the vehicle arm.

Dr. Harper characterized the 63% reduction as “pretty good, but is it good enough or fast enough? I don’t think so, so even with a great drug like this, I would use something else. You can use two medications sometimes to get people better faster. There’s room to bring in something for that background erythema.”

Minocycline 1.5% foam is colored yellow and may stain fabric. “It contains coconut oil, soybean oil, and light mineral oil,” she said. “Most people prefer to use this at bedtime, but you don’t have to.”

Another treatment option is 5% microencapsulated benzoyl peroxide cream, which is FDA approved for inflammatory lesions of rosacea.

“What’s the mechanism of action? Probably not being antimicrobial,” Dr. Harper said. “I think it’s probably at least in part anti-inflammatory, because we have some data to show that it’s killing Demodex [mites]. If Demodex [are] a trigger of inflammation, and we can lessen Demodex, then we could lessen the inflammatory response after that.”

The drug’s approval was based on data from two positive, identical phase 3 randomized, double-blind, multicenter, 12-week clinical trials that evaluated its safety compared with vehicle in 733 people with inflammatory lesions of rosacea (NCT03564119 and NCT03448939).

At week 12, inflammatory lesions of rosacea were reduced by nearly 70% in both trials among those who received 5% microencapsulated benzoyl peroxide cream, compared with 38%-46% among those who received the vehicle. Also, nearly 50% of subjects in the treatment groups were clear or almost clear at 12 weeks, compared with 38%-46% of those who received the vehicle.

Dr. Harper added that about one-quarter of patients in the treatment group of the trials were clear or almost clear by week 4. “That’s pretty fast,” she said, noting that the product’s microencapsulated shell acts as a fenestrated barrier. “It has little openings, which means that it takes a while for the drug to work itself out,” she said. “I think of it as being like a speed bump for benzoyl peroxide delivery. It has to get through this little maze before it lands on the skin. We think that is what has helped with tolerability.”

Oral sarecycline, a narrow spectrum tetracycline that was FDA approved for acne in 2018, may also benefit rosacea patients. In a 12-week, investigator-blinded pilot study, 72 patients with papulopustular rosacea were assigned to receive sarecycline, while 25 received a multivitamin.

By week 12, 75% of patients in the sarecycline group were clear, compared with 16% of those in the multivitamin group, while the inflammatory lesion counts dropped from baseline by 80% and 60%, respectively. Studies of sarecycline for acne have demonstrated similar rates of vertigo, dizziness, and sunburn to those of placebo.

“There were also low rates of gastrointestinal disturbances,” Dr. Harper said. “That’s important in rosacea, because there is no bacterial pathogen.”

Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speakers bureau for Almirall, EPI, Galderma, Ortho, and Vyne.

Medscape Live and this news organization are owned by the same parent company.

The days of strictly classifying rosacea patients as having erythematotelangiectatic, papulopustular, phymatous, or ocular forms of the skin condition are over. At least they should be, according to Julie C. Harper, MD.

“How many people with papules and pustules don’t also have redness?” Dr. Harper, who practices in Birmingham, Ala., said at Medscape Live’s annual Coastal Dermatology Symposium. “If we’re not careful, and we try to classify a person into a subtype of rosacea, we end up treating only part of their rosacea; we don’t treat all of it. We have seen this in the literature,” she added.

“The idea now is to take a phenotypic approach to rosacea. What we mean by that is that you look at the patient, you document every part of rosacea that you see, and you treat according to that,” she continued. “That person with papules and pustules may also have phyma and ocular disease. They may have telangiectasia and persistent background erythema. They may also have flushing.”

Dr. Harper incorporates the mnemonic “STOP” to her visits with rosacea patients.

S stands for: Identify signs and symptoms of the condition. “Listen to the patient for symptoms,” she advised. “We’ve learned to listen to darker skinned patients for what they tell us about erythema, for example, because we may not be able to see it, yet they are experiencing it. They may also have symptomatic burning, itching, and stinging.”

T stands for: Discuss triggers. “Ask patients, ‘what is it that makes your rosacea worse?’ That’s different for everyone,” she said.

O stands for: Agree on a treatment outcome. “Ask, ‘what is it that really bothers you? Are you bothered by the bumps? The redness?’ ” she said.

“The P stands for: Develop a plan that addresses all of that,” she said.

Different treatments for different rosacea symptoms

No one-size-fits-all treatment exists for rosacea. Options that work well for papules and pustules aren’t effective for redness. Similarly, products that work for redness don’t work for telangiectasia.

“Different lesions and signs of rosacea will likely require multiple modes of treatment,” Dr. Harper said. “So, when you evaluate your rosacea patients, if they’re doing great, don’t change their regimen. But if you see somebody who is not well controlled, is there an opportunity for you to come in and add something to that regimen that may make them better? Maybe so.”

Treatment options indicated for papules and pustules include ivermectin, metronidazole, azelaic acid, sodium sulfacetamide/sulfur, modified release doxycycline, minocycline foam, and encapsulated benzoyl peroxide.

Options indicated for persistent background erythema include brimonidine and oxymetazoline, while device-based treatments include the pulsed dye laser, the KTP laser, intense pulsed light, and electrosurgery.
 

Anti-inflammatory action for pustules and papules

A relatively new product indicated for pustules and papules is minocycline 1.5% foam, the only minocycline that is FDA approved to treat rosacea.

“There is no oral minocycline product approved for rosacea yet,” Dr. Harper said. “There is not a known bacterial pathogen in rosacea. Tetracyclines likely work in rosacea by inhibiting neutrophil chemotaxis, inhibiting MMP and thus KLK-5 and LL-37, inhibiting pro-inflammatory cytokines, downregulating reactive oxygen species, and inhibiting angiogenesis.”

In two 12-week, phase 3 randomized studies of 1,522 patients with moderate to severe rosacea, participants were assigned to receive minocycline 5% foam or a vehicle that contained mineral oil and coconut oil.

At week 12, about 50% of patients who received minocycline 5% foam were clear, compared with about 40% of those in the vehicle arm. Also, the reduction of lesion count was about 63% for patients in the treatment group, compared with a reduction of about 54% in the vehicle arm.

Dr. Harper characterized the 63% reduction as “pretty good, but is it good enough or fast enough? I don’t think so, so even with a great drug like this, I would use something else. You can use two medications sometimes to get people better faster. There’s room to bring in something for that background erythema.”

Minocycline 1.5% foam is colored yellow and may stain fabric. “It contains coconut oil, soybean oil, and light mineral oil,” she said. “Most people prefer to use this at bedtime, but you don’t have to.”

Another treatment option is 5% microencapsulated benzoyl peroxide cream, which is FDA approved for inflammatory lesions of rosacea.

“What’s the mechanism of action? Probably not being antimicrobial,” Dr. Harper said. “I think it’s probably at least in part anti-inflammatory, because we have some data to show that it’s killing Demodex [mites]. If Demodex [are] a trigger of inflammation, and we can lessen Demodex, then we could lessen the inflammatory response after that.”

The drug’s approval was based on data from two positive, identical phase 3 randomized, double-blind, multicenter, 12-week clinical trials that evaluated its safety compared with vehicle in 733 people with inflammatory lesions of rosacea (NCT03564119 and NCT03448939).

At week 12, inflammatory lesions of rosacea were reduced by nearly 70% in both trials among those who received 5% microencapsulated benzoyl peroxide cream, compared with 38%-46% among those who received the vehicle. Also, nearly 50% of subjects in the treatment groups were clear or almost clear at 12 weeks, compared with 38%-46% of those who received the vehicle.

Dr. Harper added that about one-quarter of patients in the treatment group of the trials were clear or almost clear by week 4. “That’s pretty fast,” she said, noting that the product’s microencapsulated shell acts as a fenestrated barrier. “It has little openings, which means that it takes a while for the drug to work itself out,” she said. “I think of it as being like a speed bump for benzoyl peroxide delivery. It has to get through this little maze before it lands on the skin. We think that is what has helped with tolerability.”

Oral sarecycline, a narrow spectrum tetracycline that was FDA approved for acne in 2018, may also benefit rosacea patients. In a 12-week, investigator-blinded pilot study, 72 patients with papulopustular rosacea were assigned to receive sarecycline, while 25 received a multivitamin.

By week 12, 75% of patients in the sarecycline group were clear, compared with 16% of those in the multivitamin group, while the inflammatory lesion counts dropped from baseline by 80% and 60%, respectively. Studies of sarecycline for acne have demonstrated similar rates of vertigo, dizziness, and sunburn to those of placebo.

“There were also low rates of gastrointestinal disturbances,” Dr. Harper said. “That’s important in rosacea, because there is no bacterial pathogen.”

Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speakers bureau for Almirall, EPI, Galderma, Ortho, and Vyne.

Medscape Live and this news organization are owned by the same parent company.

Some pediatricians believe that molluscum contagiosum (MC) should not be treated because they usually self-resolve in 6-18 months, but Rebecca Smith, MD, sees things differently.

“If you don’t treat them, they’re going to spread,” Dr. Smith, who practices dermatology in Fort Mill, S.C., said at Medscape Live’s annual Coastal Dermatology Symposium. “They’re going to be itchy, they can spread on the patient themselves and then to others, and they can cause scarring. The prevalence is anywhere from 5% to 11%. That means there are 6 million patients out there, just waiting to come into your clinics.”

To date, no treatment has been approved by the Food and Drug Administration for MC, although a laundry list of agents have been tried, including cantharidin; cryotherapy; curettage with and without imiquimod; sinecatechins ointment, 15%; imiquimod; and retinoids. And there are several treatments that are being investigated.

A 2017 Cochrane review of 22 studies involving 1,650 patients demonstrated that no single intervention has been consistently effective in treating MC. “Most of the studies were actually very low quality,” said Dr. Smith, who was not involved with the analysis. “The one high quality study showed that imiquimod did not work any better than its vehicle.”
 

Investigational treatments

One of the products in the pipeline is VP-102, a proprietary drug-device combination of cantharidin 0.7% administered through a single-use precision applicator, which has been evaluated in phase 3 studies of patients with molluscum aged 2 years and older. It features a visualization agent so that the person applying the drug can see which lesions have been treated. It also contains a bittering agent to mitigate oral ingestion by children.

Courtesy Dr. Sarah Cipriano

VP-102, which is being developed by Verrica Pharmaceuticals, is applied once every 21 days in up to 4 applications, and multiple lesions can be treated with one applicator. “It’s a stable concentration with a good shelf life, and two phase 3 randomized studies have shown about a 50% complete clearance of new and existing lesions at day 84,” Dr. Smith said. Those studies enrolled children and adults.

A separate analysis of the same data presented at a meeting in 2019 showed that 77% of patients treated with VP-102 achieved greater than 75% clearance, while 65.8% achieved more than 90% clearance.

The new kid on the block is a gel formulation of a nitric oxide–releasing medication, berdazimer 10.3%, a first-in-class topical treatment being developed by Novan, which can be applied at home. In a multicenter study published in JAMA Dermatology, researchers randomized 444 patients to berdazimer gel 10.3% and 447 to a placebo gel, applied once daily in a thin layer on all MC lesions for 12 weeks. The study was conducted at 55 clinics across the United States between Sept. 1, 2020, and July 21, 2021. The mean age of the patients was about 6.5 years and participants had 3-70 raised MC lesions; those with sexually transmitted MC or MC in the periocular area were excluded. The primary endpoint was complete clearance of MC lesions after 12 weeks of treatment.

At 12 weeks, significantly more patients treated with berdazimer gel achieved complete clearance than those on vehicle (32.4% vs. 19.7%; P < .001). A total of 64 (14.4%) patients in the berdazimer group discontinued treatment because of MC clearance, compared with 40 patients (8.9%) in the vehicle group.

More recently, investigators evaluated autoinoculation vs. 35% trichloroacetic acid (TCA) for the treatment of MC. Autoinoculation involves puncturing the perilesional and lesional skin 5-7 times with an insulin syringe. “This gets a little bit of the virus into the dermis, and you hope to elicit an immune response,” explained Dr. Smith, who was not involved with the study. At 3 months, 80% of patients in the autoinoculation group achieved complete clearance, compared with 62% of those in the TCA group, while recurrence at 6 months was 3% vs. 40%, respectively.

Manual extraction of MC lesions is another option. “I love to pop the cores out with my thumbs,” Dr. Smith said. “You have to pick the patients who can tolerate this, and the MC lesions need to be ripe and ready.”

For ophthalmic lesions, watchful waiting is advisable unless the MC lesions are symptomatic or bothersome or large lesions form on the lid margin, which may cause ocular irritation or even a corneal abrasion. “If a patient presents with a multisite infection that includes ocular lesions, treat lesions on other parts of the body and keep your fingers crossed that a systemic immune response occurs,” she said.

The desired immune response is known as the “BOTE” sign (the beginning of the end), which heralds the clearance of the molluscum infection. This often appears as reddening of all the MC lesions and occasionally as a granulomatous “id-like” reaction especially on the extensor elbows and knees. “When this happens, it often scares the patients,” Dr. Smith said. But she explains that this is a positive development, and that “this means that the lesions are about to self-resolve.”

Dr. Smith disclosed that she serves as a speaker or a member of the speakers bureau for Amgen, CeraVe, EPI, Galderma, InCyte, Lilly, Pfizer, Regeneron, Sanofi Genzyme, and Sun. She also serves as an advisor or consultant for Janssen, Lilly, Regeneron, and Sanofi Genzyme.

Medscape Live and this news organization are owned by the same parent company.

Some pediatricians believe that molluscum contagiosum (MC) should not be treated because they usually self-resolve in 6-18 months, but Rebecca Smith, MD, sees things differently.

“If you don’t treat them, they’re going to spread,” Dr. Smith, who practices dermatology in Fort Mill, S.C., said at Medscape Live’s annual Coastal Dermatology Symposium. “They’re going to be itchy, they can spread on the patient themselves and then to others, and they can cause scarring. The prevalence is anywhere from 5% to 11%. That means there are 6 million patients out there, just waiting to come into your clinics.”

To date, no treatment has been approved by the Food and Drug Administration for MC, although a laundry list of agents have been tried, including cantharidin; cryotherapy; curettage with and without imiquimod; sinecatechins ointment, 15%; imiquimod; and retinoids. And there are several treatments that are being investigated.

A 2017 Cochrane review of 22 studies involving 1,650 patients demonstrated that no single intervention has been consistently effective in treating MC. “Most of the studies were actually very low quality,” said Dr. Smith, who was not involved with the analysis. “The one high quality study showed that imiquimod did not work any better than its vehicle.”
 

Investigational treatments

One of the products in the pipeline is VP-102, a proprietary drug-device combination of cantharidin 0.7% administered through a single-use precision applicator, which has been evaluated in phase 3 studies of patients with molluscum aged 2 years and older. It features a visualization agent so that the person applying the drug can see which lesions have been treated. It also contains a bittering agent to mitigate oral ingestion by children.

Courtesy Dr. Sarah Cipriano

VP-102, which is being developed by Verrica Pharmaceuticals, is applied once every 21 days in up to 4 applications, and multiple lesions can be treated with one applicator. “It’s a stable concentration with a good shelf life, and two phase 3 randomized studies have shown about a 50% complete clearance of new and existing lesions at day 84,” Dr. Smith said. Those studies enrolled children and adults.

A separate analysis of the same data presented at a meeting in 2019 showed that 77% of patients treated with VP-102 achieved greater than 75% clearance, while 65.8% achieved more than 90% clearance.

The new kid on the block is a gel formulation of a nitric oxide–releasing medication, berdazimer 10.3%, a first-in-class topical treatment being developed by Novan, which can be applied at home. In a multicenter study published in JAMA Dermatology, researchers randomized 444 patients to berdazimer gel 10.3% and 447 to a placebo gel, applied once daily in a thin layer on all MC lesions for 12 weeks. The study was conducted at 55 clinics across the United States between Sept. 1, 2020, and July 21, 2021. The mean age of the patients was about 6.5 years and participants had 3-70 raised MC lesions; those with sexually transmitted MC or MC in the periocular area were excluded. The primary endpoint was complete clearance of MC lesions after 12 weeks of treatment.

At 12 weeks, significantly more patients treated with berdazimer gel achieved complete clearance than those on vehicle (32.4% vs. 19.7%; P < .001). A total of 64 (14.4%) patients in the berdazimer group discontinued treatment because of MC clearance, compared with 40 patients (8.9%) in the vehicle group.

More recently, investigators evaluated autoinoculation vs. 35% trichloroacetic acid (TCA) for the treatment of MC. Autoinoculation involves puncturing the perilesional and lesional skin 5-7 times with an insulin syringe. “This gets a little bit of the virus into the dermis, and you hope to elicit an immune response,” explained Dr. Smith, who was not involved with the study. At 3 months, 80% of patients in the autoinoculation group achieved complete clearance, compared with 62% of those in the TCA group, while recurrence at 6 months was 3% vs. 40%, respectively.

Manual extraction of MC lesions is another option. “I love to pop the cores out with my thumbs,” Dr. Smith said. “You have to pick the patients who can tolerate this, and the MC lesions need to be ripe and ready.”

For ophthalmic lesions, watchful waiting is advisable unless the MC lesions are symptomatic or bothersome or large lesions form on the lid margin, which may cause ocular irritation or even a corneal abrasion. “If a patient presents with a multisite infection that includes ocular lesions, treat lesions on other parts of the body and keep your fingers crossed that a systemic immune response occurs,” she said.

The desired immune response is known as the “BOTE” sign (the beginning of the end), which heralds the clearance of the molluscum infection. This often appears as reddening of all the MC lesions and occasionally as a granulomatous “id-like” reaction especially on the extensor elbows and knees. “When this happens, it often scares the patients,” Dr. Smith said. But she explains that this is a positive development, and that “this means that the lesions are about to self-resolve.”

Dr. Smith disclosed that she serves as a speaker or a member of the speakers bureau for Amgen, CeraVe, EPI, Galderma, InCyte, Lilly, Pfizer, Regeneron, Sanofi Genzyme, and Sun. She also serves as an advisor or consultant for Janssen, Lilly, Regeneron, and Sanofi Genzyme.

Medscape Live and this news organization are owned by the same parent company.

Some pediatricians believe that molluscum contagiosum (MC) should not be treated because they usually self-resolve in 6-18 months, but Rebecca Smith, MD, sees things differently.

“If you don’t treat them, they’re going to spread,” Dr. Smith, who practices dermatology in Fort Mill, S.C., said at Medscape Live’s annual Coastal Dermatology Symposium. “They’re going to be itchy, they can spread on the patient themselves and then to others, and they can cause scarring. The prevalence is anywhere from 5% to 11%. That means there are 6 million patients out there, just waiting to come into your clinics.”

To date, no treatment has been approved by the Food and Drug Administration for MC, although a laundry list of agents have been tried, including cantharidin; cryotherapy; curettage with and without imiquimod; sinecatechins ointment, 15%; imiquimod; and retinoids. And there are several treatments that are being investigated.

A 2017 Cochrane review of 22 studies involving 1,650 patients demonstrated that no single intervention has been consistently effective in treating MC. “Most of the studies were actually very low quality,” said Dr. Smith, who was not involved with the analysis. “The one high quality study showed that imiquimod did not work any better than its vehicle.”
 

Investigational treatments

One of the products in the pipeline is VP-102, a proprietary drug-device combination of cantharidin 0.7% administered through a single-use precision applicator, which has been evaluated in phase 3 studies of patients with molluscum aged 2 years and older. It features a visualization agent so that the person applying the drug can see which lesions have been treated. It also contains a bittering agent to mitigate oral ingestion by children.

Courtesy Dr. Sarah Cipriano

VP-102, which is being developed by Verrica Pharmaceuticals, is applied once every 21 days in up to 4 applications, and multiple lesions can be treated with one applicator. “It’s a stable concentration with a good shelf life, and two phase 3 randomized studies have shown about a 50% complete clearance of new and existing lesions at day 84,” Dr. Smith said. Those studies enrolled children and adults.

A separate analysis of the same data presented at a meeting in 2019 showed that 77% of patients treated with VP-102 achieved greater than 75% clearance, while 65.8% achieved more than 90% clearance.

The new kid on the block is a gel formulation of a nitric oxide–releasing medication, berdazimer 10.3%, a first-in-class topical treatment being developed by Novan, which can be applied at home. In a multicenter study published in JAMA Dermatology, researchers randomized 444 patients to berdazimer gel 10.3% and 447 to a placebo gel, applied once daily in a thin layer on all MC lesions for 12 weeks. The study was conducted at 55 clinics across the United States between Sept. 1, 2020, and July 21, 2021. The mean age of the patients was about 6.5 years and participants had 3-70 raised MC lesions; those with sexually transmitted MC or MC in the periocular area were excluded. The primary endpoint was complete clearance of MC lesions after 12 weeks of treatment.

At 12 weeks, significantly more patients treated with berdazimer gel achieved complete clearance than those on vehicle (32.4% vs. 19.7%; P < .001). A total of 64 (14.4%) patients in the berdazimer group discontinued treatment because of MC clearance, compared with 40 patients (8.9%) in the vehicle group.

More recently, investigators evaluated autoinoculation vs. 35% trichloroacetic acid (TCA) for the treatment of MC. Autoinoculation involves puncturing the perilesional and lesional skin 5-7 times with an insulin syringe. “This gets a little bit of the virus into the dermis, and you hope to elicit an immune response,” explained Dr. Smith, who was not involved with the study. At 3 months, 80% of patients in the autoinoculation group achieved complete clearance, compared with 62% of those in the TCA group, while recurrence at 6 months was 3% vs. 40%, respectively.

Manual extraction of MC lesions is another option. “I love to pop the cores out with my thumbs,” Dr. Smith said. “You have to pick the patients who can tolerate this, and the MC lesions need to be ripe and ready.”

For ophthalmic lesions, watchful waiting is advisable unless the MC lesions are symptomatic or bothersome or large lesions form on the lid margin, which may cause ocular irritation or even a corneal abrasion. “If a patient presents with a multisite infection that includes ocular lesions, treat lesions on other parts of the body and keep your fingers crossed that a systemic immune response occurs,” she said.

The desired immune response is known as the “BOTE” sign (the beginning of the end), which heralds the clearance of the molluscum infection. This often appears as reddening of all the MC lesions and occasionally as a granulomatous “id-like” reaction especially on the extensor elbows and knees. “When this happens, it often scares the patients,” Dr. Smith said. But she explains that this is a positive development, and that “this means that the lesions are about to self-resolve.”

Dr. Smith disclosed that she serves as a speaker or a member of the speakers bureau for Amgen, CeraVe, EPI, Galderma, InCyte, Lilly, Pfizer, Regeneron, Sanofi Genzyme, and Sun. She also serves as an advisor or consultant for Janssen, Lilly, Regeneron, and Sanofi Genzyme.

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