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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
Picosecond laser applications continue to expand
PHOENIX – Ever since PicoSure became the first picosecond laser cleared by the Food and Drug Administration for the treatment of unwanted tattoos and pigmented lesions in 2012, new uses for this technology continue to expand.
Now, These include PicoWay, PicoSure, Enlighten, PicoPlus, PiQo4, and Quanta Pico, among others.
“PicoWay technology has integrated nicely into my practice in Houston, the most ethnically diverse city in the country, with its ability to safely treat a number of various benign, congenital, and acquired epidermal and dermal pigmented lesions with ultrashort pulse duration and low thermal impact, which greatly reduces the risk of postinflammatory hyperpigmentation even in darker skin types,” Paul M. Friedman, MD, director of the Dermatology and Laser Surgery Center, Houston, said at the annual conference of the American Society for Laser Medicine and Surgery.
He emphasized the importance of therapeutic clinical endpoints, noting that with q-switched lasers, “you’re looking for immediate whitening, whereas with picosecond lasers, your endpoint is slight whitening or slight darkening depending on wavelength, indication, and skin type. The ability to fractionate picosecond pulses has also allowed us to utilize this technology for photoaging as well as acne scarring.”
The PicoWay system includes a 730-nm picosecond titanium sapphire handpiece, which is FDA cleared for treatment of benign pigmented lesions and blue and green tattoo removal. Dr. Friedman said that he has seen good clinical results using the handpiece for café-au-lait macules, particularly in skin of color.
In an abstract presented at the ASLMS meeting, he and his colleagues presented a retrospective review of 12 patients with café-au-lait macules with Fitzpatrick skin types III-VI who were treated with the PicoWay 730 nm handpiece between April 2021 and January 2023. Patients received a mean of 3.1 treatments at intervals that ranged from 5 to 40 weeks. Clinical photographs were graded by three board-certified dermatologists using a 5-point visual analogue scale.
Overall, patients were rated to have a mean improvement of 26%-50%. Two patients achieved 100% clearance after four to five treatment sessions. “Café-au-lait macules with smooth borders responded less well to laser treatment, confirming prior studies at our center,” he said. “We often educate parents that café-au-lait macules may recur over time, especially with repeated sun exposure.”
Treating melasma
Dr. Friedman’s go-to devices for melasma include the low-density, low-energy 1,927-nm fractional diode laser; the 1,064 nm picosecond Nd:YAG, the low-fluence 1,064 nm Q-switched Nd:YAG with a nanosecond pulse duration, and the 595-nm pulsed dye laser for lesions exhibiting underlying vascularity. He said that combining therapies that target pigment and vasculature may be ideal to prevent relapses. “Melasma is a multifactorial condition so by improving patient education and expectation alongside advances in laser treatment of melasma, we have ultimately improved our ability to treat this condition,” he said.
“We’re approaching it from all angles, with ultraviolet photography and spectrocolorimetry, behavioral modifications, topical skin-lightening agents, broad spectrum sunscreens with protection against visible light, and oral tranexamic acid in advanced cases. Then, we intervene with these energy-based modalities, and the bottom line is, less energy and density is more, with lengthened treatment intervals. In 2023, we’re better than we’ve ever been in terms of our ability to safely and effectively improve melasma.”
Novel lasers
Dr. Friedman also described the UltraClear, a novel ablative fractional 2,910-nm erbium-doped glass fiber laser that delivers a customized blend of ablation and coagulation based on the patient’s condition, skin type, and tolerability for down time. He provided an overview of the versatility of what he described as highly customizable technology for conditions such as photoaging and dyschromia in patients of various skin types, making it a very versatile platform in his practice.
The AVAVA MIRIA system is a “next generation” laser “where you’re able to use a focal point. Basically, you’re treating the skin from the inside out in a 3D manner and you’re able to focus intradermally up to 1 mm with high energy 1,064 nm or 1,550 nm,” he said. “It’s a unique conical geometry that spares the epidermis, combined with sapphire tip cooling and images the skin at the same time with the potential for personalized treatments of dyschromia and photoaging in all skin types. It’s truly remarkable where the technology is heading.”
Dr. Friedman disclosed that he has received consulting fees from Allergan, Galderma, Acclaro, Merz Aesthetics, Solta Medical, and Cytrellis. He has conducted contracted research for Sofwave and is a member of the speakers bureau for Solta Medical and Candela.
PHOENIX – Ever since PicoSure became the first picosecond laser cleared by the Food and Drug Administration for the treatment of unwanted tattoos and pigmented lesions in 2012, new uses for this technology continue to expand.
Now, These include PicoWay, PicoSure, Enlighten, PicoPlus, PiQo4, and Quanta Pico, among others.
“PicoWay technology has integrated nicely into my practice in Houston, the most ethnically diverse city in the country, with its ability to safely treat a number of various benign, congenital, and acquired epidermal and dermal pigmented lesions with ultrashort pulse duration and low thermal impact, which greatly reduces the risk of postinflammatory hyperpigmentation even in darker skin types,” Paul M. Friedman, MD, director of the Dermatology and Laser Surgery Center, Houston, said at the annual conference of the American Society for Laser Medicine and Surgery.
He emphasized the importance of therapeutic clinical endpoints, noting that with q-switched lasers, “you’re looking for immediate whitening, whereas with picosecond lasers, your endpoint is slight whitening or slight darkening depending on wavelength, indication, and skin type. The ability to fractionate picosecond pulses has also allowed us to utilize this technology for photoaging as well as acne scarring.”
The PicoWay system includes a 730-nm picosecond titanium sapphire handpiece, which is FDA cleared for treatment of benign pigmented lesions and blue and green tattoo removal. Dr. Friedman said that he has seen good clinical results using the handpiece for café-au-lait macules, particularly in skin of color.
In an abstract presented at the ASLMS meeting, he and his colleagues presented a retrospective review of 12 patients with café-au-lait macules with Fitzpatrick skin types III-VI who were treated with the PicoWay 730 nm handpiece between April 2021 and January 2023. Patients received a mean of 3.1 treatments at intervals that ranged from 5 to 40 weeks. Clinical photographs were graded by three board-certified dermatologists using a 5-point visual analogue scale.
Overall, patients were rated to have a mean improvement of 26%-50%. Two patients achieved 100% clearance after four to five treatment sessions. “Café-au-lait macules with smooth borders responded less well to laser treatment, confirming prior studies at our center,” he said. “We often educate parents that café-au-lait macules may recur over time, especially with repeated sun exposure.”
Treating melasma
Dr. Friedman’s go-to devices for melasma include the low-density, low-energy 1,927-nm fractional diode laser; the 1,064 nm picosecond Nd:YAG, the low-fluence 1,064 nm Q-switched Nd:YAG with a nanosecond pulse duration, and the 595-nm pulsed dye laser for lesions exhibiting underlying vascularity. He said that combining therapies that target pigment and vasculature may be ideal to prevent relapses. “Melasma is a multifactorial condition so by improving patient education and expectation alongside advances in laser treatment of melasma, we have ultimately improved our ability to treat this condition,” he said.
“We’re approaching it from all angles, with ultraviolet photography and spectrocolorimetry, behavioral modifications, topical skin-lightening agents, broad spectrum sunscreens with protection against visible light, and oral tranexamic acid in advanced cases. Then, we intervene with these energy-based modalities, and the bottom line is, less energy and density is more, with lengthened treatment intervals. In 2023, we’re better than we’ve ever been in terms of our ability to safely and effectively improve melasma.”
Novel lasers
Dr. Friedman also described the UltraClear, a novel ablative fractional 2,910-nm erbium-doped glass fiber laser that delivers a customized blend of ablation and coagulation based on the patient’s condition, skin type, and tolerability for down time. He provided an overview of the versatility of what he described as highly customizable technology for conditions such as photoaging and dyschromia in patients of various skin types, making it a very versatile platform in his practice.
The AVAVA MIRIA system is a “next generation” laser “where you’re able to use a focal point. Basically, you’re treating the skin from the inside out in a 3D manner and you’re able to focus intradermally up to 1 mm with high energy 1,064 nm or 1,550 nm,” he said. “It’s a unique conical geometry that spares the epidermis, combined with sapphire tip cooling and images the skin at the same time with the potential for personalized treatments of dyschromia and photoaging in all skin types. It’s truly remarkable where the technology is heading.”
Dr. Friedman disclosed that he has received consulting fees from Allergan, Galderma, Acclaro, Merz Aesthetics, Solta Medical, and Cytrellis. He has conducted contracted research for Sofwave and is a member of the speakers bureau for Solta Medical and Candela.
PHOENIX – Ever since PicoSure became the first picosecond laser cleared by the Food and Drug Administration for the treatment of unwanted tattoos and pigmented lesions in 2012, new uses for this technology continue to expand.
Now, These include PicoWay, PicoSure, Enlighten, PicoPlus, PiQo4, and Quanta Pico, among others.
“PicoWay technology has integrated nicely into my practice in Houston, the most ethnically diverse city in the country, with its ability to safely treat a number of various benign, congenital, and acquired epidermal and dermal pigmented lesions with ultrashort pulse duration and low thermal impact, which greatly reduces the risk of postinflammatory hyperpigmentation even in darker skin types,” Paul M. Friedman, MD, director of the Dermatology and Laser Surgery Center, Houston, said at the annual conference of the American Society for Laser Medicine and Surgery.
He emphasized the importance of therapeutic clinical endpoints, noting that with q-switched lasers, “you’re looking for immediate whitening, whereas with picosecond lasers, your endpoint is slight whitening or slight darkening depending on wavelength, indication, and skin type. The ability to fractionate picosecond pulses has also allowed us to utilize this technology for photoaging as well as acne scarring.”
The PicoWay system includes a 730-nm picosecond titanium sapphire handpiece, which is FDA cleared for treatment of benign pigmented lesions and blue and green tattoo removal. Dr. Friedman said that he has seen good clinical results using the handpiece for café-au-lait macules, particularly in skin of color.
In an abstract presented at the ASLMS meeting, he and his colleagues presented a retrospective review of 12 patients with café-au-lait macules with Fitzpatrick skin types III-VI who were treated with the PicoWay 730 nm handpiece between April 2021 and January 2023. Patients received a mean of 3.1 treatments at intervals that ranged from 5 to 40 weeks. Clinical photographs were graded by three board-certified dermatologists using a 5-point visual analogue scale.
Overall, patients were rated to have a mean improvement of 26%-50%. Two patients achieved 100% clearance after four to five treatment sessions. “Café-au-lait macules with smooth borders responded less well to laser treatment, confirming prior studies at our center,” he said. “We often educate parents that café-au-lait macules may recur over time, especially with repeated sun exposure.”
Treating melasma
Dr. Friedman’s go-to devices for melasma include the low-density, low-energy 1,927-nm fractional diode laser; the 1,064 nm picosecond Nd:YAG, the low-fluence 1,064 nm Q-switched Nd:YAG with a nanosecond pulse duration, and the 595-nm pulsed dye laser for lesions exhibiting underlying vascularity. He said that combining therapies that target pigment and vasculature may be ideal to prevent relapses. “Melasma is a multifactorial condition so by improving patient education and expectation alongside advances in laser treatment of melasma, we have ultimately improved our ability to treat this condition,” he said.
“We’re approaching it from all angles, with ultraviolet photography and spectrocolorimetry, behavioral modifications, topical skin-lightening agents, broad spectrum sunscreens with protection against visible light, and oral tranexamic acid in advanced cases. Then, we intervene with these energy-based modalities, and the bottom line is, less energy and density is more, with lengthened treatment intervals. In 2023, we’re better than we’ve ever been in terms of our ability to safely and effectively improve melasma.”
Novel lasers
Dr. Friedman also described the UltraClear, a novel ablative fractional 2,910-nm erbium-doped glass fiber laser that delivers a customized blend of ablation and coagulation based on the patient’s condition, skin type, and tolerability for down time. He provided an overview of the versatility of what he described as highly customizable technology for conditions such as photoaging and dyschromia in patients of various skin types, making it a very versatile platform in his practice.
The AVAVA MIRIA system is a “next generation” laser “where you’re able to use a focal point. Basically, you’re treating the skin from the inside out in a 3D manner and you’re able to focus intradermally up to 1 mm with high energy 1,064 nm or 1,550 nm,” he said. “It’s a unique conical geometry that spares the epidermis, combined with sapphire tip cooling and images the skin at the same time with the potential for personalized treatments of dyschromia and photoaging in all skin types. It’s truly remarkable where the technology is heading.”
Dr. Friedman disclosed that he has received consulting fees from Allergan, Galderma, Acclaro, Merz Aesthetics, Solta Medical, and Cytrellis. He has conducted contracted research for Sofwave and is a member of the speakers bureau for Solta Medical and Candela.
FROM ASLMS 2023
Two phase 3 trials show benefits of dupilumab for prurigo nodularis
The results, which were published online in Nature Medicine, were the basis for the FDA approval of dupilumab (Dupixent) for adults with PN in September 2022, the first treatment approved for treating PN in the United States.
“These positive studies support the involvement of type 2 cytokines in driving PN disease pathogenesis and the targeting of the [interleukin]-4/IL-13 axis as a novel therapeutic paradigm for patients with PN,” wrote the researchers, who were led by principal investigator Gil Yosipovitch, MD, professor of dermatology at the University of Miami, Fla. Dupilumab, an IL-4 receptor alpha antagonist, blocks the shared receptor component (IL-4R alpha) for IL-4 and IL-13.
For the two phase 3 trials, which were called LIBERTY-PN PRIME and PRIME2 and were sponsored by Sanofi and Regeneron Pharmaceuticals, researchers randomized adults with PN with 20 or more nodules and severe itch uncontrolled with topical therapies 1:1 to 300 mg dupilumab or placebo subcutaneously every 2 weeks for 24 weeks. The primary endpoint was pruritus improvement, which was measured by the proportion of patients with a 4-point or greater reduction in Worst Itch Numeric Rating Scale (WI-NRS) from baseline at week 24 (PRIME) or week 12 (PRIME2). Key secondary endpoints included a reduction in the number of nodules to 5 or fewer at week 24.
PRIME and PRIME2 enrolled 151 and 160 patients, respectively. In PRIME, 60% of patients in the dupilumab arm achieved a 4-point or greater reduction in the WI-NRS at week 24, compared with 18.4% of patients in the placebo arm (P < .001). In PRIME2, 37.2% of patients in the dupilumab arm achieved a 4-point or greater reduction in the WI-NRS at week 12, compared with 22% of patients in the placebo arm (P = .022).
The researchers also reported that, from an initial baseline of 20 to greater than 100 nodules, 32.0% of dupilumab-treated patients in PRIME and 25.6% in PRIME2 showed a reduction to 5 nodules or fewer, which corresponded to a response of “clear” or “almost clear” skin at week 12, compared with 11.8% and 12.2% of placebo-treated patients, respectively. This treatment effect on skin lesions continued to improve after week 12, with 48% of dupilumab-treated patients in PRIME and 44.9% in PRIME2 having five nodules or fewer at week 24, compared with 18.4% and 15.9% of placebo-treated patients, respectively. Safety was consistent with the known dupilumab safety profile.
“Validation is the first success of this paper,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study. “While both the safety and efficacy of dupilumab in these two phase 3 programs is the meat of the matter, nuanced highlights for me include the rigid nature of the exclusion criteria to ensure a study population that truly has PN as a stand-alone disease, rather than a secondary finding as we once believed to be the entire story. I think it’s important for us to recognize that it’s not one or the other, rather there is both ‘primary’ prurigo nodularis, and then there is secondary prurigo nodularis associated with something else [a wide range of underlying medical conditions], just like we divide primary and secondary hyperhidrosis.”
Dr. Yosipovitch reported having competing interests with several pharmaceutical companies, including Regeneron and Sanofi. Dr. Friedman disclosed that he is a consultant to and a speaker for Regeneron.
The results, which were published online in Nature Medicine, were the basis for the FDA approval of dupilumab (Dupixent) for adults with PN in September 2022, the first treatment approved for treating PN in the United States.
“These positive studies support the involvement of type 2 cytokines in driving PN disease pathogenesis and the targeting of the [interleukin]-4/IL-13 axis as a novel therapeutic paradigm for patients with PN,” wrote the researchers, who were led by principal investigator Gil Yosipovitch, MD, professor of dermatology at the University of Miami, Fla. Dupilumab, an IL-4 receptor alpha antagonist, blocks the shared receptor component (IL-4R alpha) for IL-4 and IL-13.
For the two phase 3 trials, which were called LIBERTY-PN PRIME and PRIME2 and were sponsored by Sanofi and Regeneron Pharmaceuticals, researchers randomized adults with PN with 20 or more nodules and severe itch uncontrolled with topical therapies 1:1 to 300 mg dupilumab or placebo subcutaneously every 2 weeks for 24 weeks. The primary endpoint was pruritus improvement, which was measured by the proportion of patients with a 4-point or greater reduction in Worst Itch Numeric Rating Scale (WI-NRS) from baseline at week 24 (PRIME) or week 12 (PRIME2). Key secondary endpoints included a reduction in the number of nodules to 5 or fewer at week 24.
PRIME and PRIME2 enrolled 151 and 160 patients, respectively. In PRIME, 60% of patients in the dupilumab arm achieved a 4-point or greater reduction in the WI-NRS at week 24, compared with 18.4% of patients in the placebo arm (P < .001). In PRIME2, 37.2% of patients in the dupilumab arm achieved a 4-point or greater reduction in the WI-NRS at week 12, compared with 22% of patients in the placebo arm (P = .022).
The researchers also reported that, from an initial baseline of 20 to greater than 100 nodules, 32.0% of dupilumab-treated patients in PRIME and 25.6% in PRIME2 showed a reduction to 5 nodules or fewer, which corresponded to a response of “clear” or “almost clear” skin at week 12, compared with 11.8% and 12.2% of placebo-treated patients, respectively. This treatment effect on skin lesions continued to improve after week 12, with 48% of dupilumab-treated patients in PRIME and 44.9% in PRIME2 having five nodules or fewer at week 24, compared with 18.4% and 15.9% of placebo-treated patients, respectively. Safety was consistent with the known dupilumab safety profile.
“Validation is the first success of this paper,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study. “While both the safety and efficacy of dupilumab in these two phase 3 programs is the meat of the matter, nuanced highlights for me include the rigid nature of the exclusion criteria to ensure a study population that truly has PN as a stand-alone disease, rather than a secondary finding as we once believed to be the entire story. I think it’s important for us to recognize that it’s not one or the other, rather there is both ‘primary’ prurigo nodularis, and then there is secondary prurigo nodularis associated with something else [a wide range of underlying medical conditions], just like we divide primary and secondary hyperhidrosis.”
Dr. Yosipovitch reported having competing interests with several pharmaceutical companies, including Regeneron and Sanofi. Dr. Friedman disclosed that he is a consultant to and a speaker for Regeneron.
The results, which were published online in Nature Medicine, were the basis for the FDA approval of dupilumab (Dupixent) for adults with PN in September 2022, the first treatment approved for treating PN in the United States.
“These positive studies support the involvement of type 2 cytokines in driving PN disease pathogenesis and the targeting of the [interleukin]-4/IL-13 axis as a novel therapeutic paradigm for patients with PN,” wrote the researchers, who were led by principal investigator Gil Yosipovitch, MD, professor of dermatology at the University of Miami, Fla. Dupilumab, an IL-4 receptor alpha antagonist, blocks the shared receptor component (IL-4R alpha) for IL-4 and IL-13.
For the two phase 3 trials, which were called LIBERTY-PN PRIME and PRIME2 and were sponsored by Sanofi and Regeneron Pharmaceuticals, researchers randomized adults with PN with 20 or more nodules and severe itch uncontrolled with topical therapies 1:1 to 300 mg dupilumab or placebo subcutaneously every 2 weeks for 24 weeks. The primary endpoint was pruritus improvement, which was measured by the proportion of patients with a 4-point or greater reduction in Worst Itch Numeric Rating Scale (WI-NRS) from baseline at week 24 (PRIME) or week 12 (PRIME2). Key secondary endpoints included a reduction in the number of nodules to 5 or fewer at week 24.
PRIME and PRIME2 enrolled 151 and 160 patients, respectively. In PRIME, 60% of patients in the dupilumab arm achieved a 4-point or greater reduction in the WI-NRS at week 24, compared with 18.4% of patients in the placebo arm (P < .001). In PRIME2, 37.2% of patients in the dupilumab arm achieved a 4-point or greater reduction in the WI-NRS at week 12, compared with 22% of patients in the placebo arm (P = .022).
The researchers also reported that, from an initial baseline of 20 to greater than 100 nodules, 32.0% of dupilumab-treated patients in PRIME and 25.6% in PRIME2 showed a reduction to 5 nodules or fewer, which corresponded to a response of “clear” or “almost clear” skin at week 12, compared with 11.8% and 12.2% of placebo-treated patients, respectively. This treatment effect on skin lesions continued to improve after week 12, with 48% of dupilumab-treated patients in PRIME and 44.9% in PRIME2 having five nodules or fewer at week 24, compared with 18.4% and 15.9% of placebo-treated patients, respectively. Safety was consistent with the known dupilumab safety profile.
“Validation is the first success of this paper,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study. “While both the safety and efficacy of dupilumab in these two phase 3 programs is the meat of the matter, nuanced highlights for me include the rigid nature of the exclusion criteria to ensure a study population that truly has PN as a stand-alone disease, rather than a secondary finding as we once believed to be the entire story. I think it’s important for us to recognize that it’s not one or the other, rather there is both ‘primary’ prurigo nodularis, and then there is secondary prurigo nodularis associated with something else [a wide range of underlying medical conditions], just like we divide primary and secondary hyperhidrosis.”
Dr. Yosipovitch reported having competing interests with several pharmaceutical companies, including Regeneron and Sanofi. Dr. Friedman disclosed that he is a consultant to and a speaker for Regeneron.
FROM NATURE MEDICINE
1,726-nm lasers poised to revolutionize acne treatment, expert predicts
PHOENIX – When Jeffrey Dover, MD, addressed audience members gathered for a session on cutting-edge technologies at the annual conference of the American Society for Laser Medicine and Surgery, he reflected on a conversation he had with R. Rox Anderson, MD, almost 40 years ago, about eventually finding a cure for acne.
“Despite the fact that we have over-the-counter therapies, prescription therapies, and all kinds of devices available to treat acne, there are still barriers to care that get in the way of treatment,” said Dr. Dover, director of SkinCare Physicians in Chestnut Hill, Mass. “If we had a device based on innovative light science that could meet the needs of the acne patient to get rid of these barriers, wouldn’t that be something wonderful?”
The answer to this question, he said, is now “yes,” because of advances in lasers that target sebaceous glands.
In a seminal paper published in 2012, Fernanda H. Sakamoto, MD, PhD, Dr. Anderson, and colleagues demonstrated the potential for a free electron laser to target sebaceous glands . Following several years of refinement, Dr. Dover said.
“With the 1,726-nm laser, there is some selective absorption in sebum in skin, which beats out absorption in the other chromophores,” he said. “But it’s not a big difference like it is, for example, for pulsed-dye lasers and vascular targets. ... This means that the therapeutic window is relatively small and protecting the rest of the epidermis and dermis is crucial to be able to target these lesions or the sebaceous gland without unnecessary damage. If we can protect the epidermis and heat just the sebaceous glands, we should be able to get Accutane-like results if we get durability [by] shrinking sebaceous glands.”
Effective cooling, whether contact cooling, bulk cooling, or air cooling, is crucial to success, he continued. “It’s got to be robust and highly specific to protect the skin, so you don’t end up with side effects that are worse than the disease.”
The AviClear laser delivers seven 3-mm spots, which takes into account the thermal relaxation times of the sebaceous glands. The algorithm delivers a treatment imprint at roughly 0.3 Hz and a 1.5-mm depth of penetration, and the device relies on contact cooling. In pivotal data submitted to the FDA, 104 individuals with moderate to severe acne received three treatments with the AviClear 1 month apart, with follow-up at 1, 3, 6, and 12 months post treatment. They had no other treatment regimens, and the primary endpoint was the percentage of patients who achieved a 50% reduction in inflammatory lesion count 3 months after the final treatment. The secondary endpoint was an Investigator’s Global Assessment (IGA) improvement of 2 or greater.
Dr. Dover, who helped design the study, said that, at 3 months, 80% of those treated achieved a 50% or greater reduction in inflammatory lesion count (P < .001). As for secondary endpoints, 36% of individuals were assessed as having clear or almost clear skin; 47% achieved a 2-point or greater improvement in IGA score, compared with baseline, and 87% achieved a 1-point or greater improvement in IGA score, compared with baseline. By 6 months, 88% of individuals achieved a 50% or greater reduction in inflammatory lesion count; this improved to 92% by 12 months (P < .001).
“All of these procedures were done with no topical anesthetic, no intralesional anesthetic, and they tolerated these quite well,” he said. “There was no down time that required medical intervention after the treatments. All posttreatment erythema and swelling resolved quickly,” and 75% of the patients were “very satisfied” with the treatments.
The Accure Laser System features a proprietary technology that precisely controls thermal gradient depth. “So instead of guessing whether you are delivering the correct amount of heat, it actually tells you,” said Dr. Dover, a past president of the ASLMS and the American Society for Dermatologic Surgery. “It correlates surface and at-depth temperatures, and there’s an infrared camera for real-time accurate temperature monitoring.” The device features highly controlled air cooling and a pulsing pattern that ensures treatment of sebaceous glands of all sizes and at all depths. The clinical end marker is peak epidermal temperature.
In a study supported by Accure, the manufacturer, researchers evaluated the efficacy of the Accure Laser System in 35 subjects with types I to VI skin, who received four monthly treatments 30-45 minutes each, and were followed 12, 26, 39, and 52 weeks following their last treatment. To date, data out to 52 weeks is available for 17 study participants. According to Dr. Dover, the researchers found 80% clearance at 12 weeks following the last treatment, with continued improvement at 52 weeks. One hundred percent of subjects responded. Side effects included erythema, edema, crusting, blisters, and inflammatory papules. “None of these were medically significant,” he said.
As dermatologists begin to incorporate the AviClear and Accure devices into their practices, Dr. Dover said that he is reminded of the conversation he had some 40 years ago with Dr. Anderson about finding a cure for acne, and he feels a bit awestruck. “These 1,726-nm lasers are effective for treating acne. I personally think they are going to revolutionize the way we treat at least some of our patients with acne. They may both be effective for treating facial acne scars. Time will tell. Further study of both scarring and acne are needed to fully categorize the benefit and to optimize treatments.”
To date no direct clinical comparisons have been made between the AviClear and Accure devices.
Dr. Dover reported that he is a consultant for Cutera, the manufacturer for AviClear. He also performs research for the company.
PHOENIX – When Jeffrey Dover, MD, addressed audience members gathered for a session on cutting-edge technologies at the annual conference of the American Society for Laser Medicine and Surgery, he reflected on a conversation he had with R. Rox Anderson, MD, almost 40 years ago, about eventually finding a cure for acne.
“Despite the fact that we have over-the-counter therapies, prescription therapies, and all kinds of devices available to treat acne, there are still barriers to care that get in the way of treatment,” said Dr. Dover, director of SkinCare Physicians in Chestnut Hill, Mass. “If we had a device based on innovative light science that could meet the needs of the acne patient to get rid of these barriers, wouldn’t that be something wonderful?”
The answer to this question, he said, is now “yes,” because of advances in lasers that target sebaceous glands.
In a seminal paper published in 2012, Fernanda H. Sakamoto, MD, PhD, Dr. Anderson, and colleagues demonstrated the potential for a free electron laser to target sebaceous glands . Following several years of refinement, Dr. Dover said.
“With the 1,726-nm laser, there is some selective absorption in sebum in skin, which beats out absorption in the other chromophores,” he said. “But it’s not a big difference like it is, for example, for pulsed-dye lasers and vascular targets. ... This means that the therapeutic window is relatively small and protecting the rest of the epidermis and dermis is crucial to be able to target these lesions or the sebaceous gland without unnecessary damage. If we can protect the epidermis and heat just the sebaceous glands, we should be able to get Accutane-like results if we get durability [by] shrinking sebaceous glands.”
Effective cooling, whether contact cooling, bulk cooling, or air cooling, is crucial to success, he continued. “It’s got to be robust and highly specific to protect the skin, so you don’t end up with side effects that are worse than the disease.”
The AviClear laser delivers seven 3-mm spots, which takes into account the thermal relaxation times of the sebaceous glands. The algorithm delivers a treatment imprint at roughly 0.3 Hz and a 1.5-mm depth of penetration, and the device relies on contact cooling. In pivotal data submitted to the FDA, 104 individuals with moderate to severe acne received three treatments with the AviClear 1 month apart, with follow-up at 1, 3, 6, and 12 months post treatment. They had no other treatment regimens, and the primary endpoint was the percentage of patients who achieved a 50% reduction in inflammatory lesion count 3 months after the final treatment. The secondary endpoint was an Investigator’s Global Assessment (IGA) improvement of 2 or greater.
Dr. Dover, who helped design the study, said that, at 3 months, 80% of those treated achieved a 50% or greater reduction in inflammatory lesion count (P < .001). As for secondary endpoints, 36% of individuals were assessed as having clear or almost clear skin; 47% achieved a 2-point or greater improvement in IGA score, compared with baseline, and 87% achieved a 1-point or greater improvement in IGA score, compared with baseline. By 6 months, 88% of individuals achieved a 50% or greater reduction in inflammatory lesion count; this improved to 92% by 12 months (P < .001).
“All of these procedures were done with no topical anesthetic, no intralesional anesthetic, and they tolerated these quite well,” he said. “There was no down time that required medical intervention after the treatments. All posttreatment erythema and swelling resolved quickly,” and 75% of the patients were “very satisfied” with the treatments.
The Accure Laser System features a proprietary technology that precisely controls thermal gradient depth. “So instead of guessing whether you are delivering the correct amount of heat, it actually tells you,” said Dr. Dover, a past president of the ASLMS and the American Society for Dermatologic Surgery. “It correlates surface and at-depth temperatures, and there’s an infrared camera for real-time accurate temperature monitoring.” The device features highly controlled air cooling and a pulsing pattern that ensures treatment of sebaceous glands of all sizes and at all depths. The clinical end marker is peak epidermal temperature.
In a study supported by Accure, the manufacturer, researchers evaluated the efficacy of the Accure Laser System in 35 subjects with types I to VI skin, who received four monthly treatments 30-45 minutes each, and were followed 12, 26, 39, and 52 weeks following their last treatment. To date, data out to 52 weeks is available for 17 study participants. According to Dr. Dover, the researchers found 80% clearance at 12 weeks following the last treatment, with continued improvement at 52 weeks. One hundred percent of subjects responded. Side effects included erythema, edema, crusting, blisters, and inflammatory papules. “None of these were medically significant,” he said.
As dermatologists begin to incorporate the AviClear and Accure devices into their practices, Dr. Dover said that he is reminded of the conversation he had some 40 years ago with Dr. Anderson about finding a cure for acne, and he feels a bit awestruck. “These 1,726-nm lasers are effective for treating acne. I personally think they are going to revolutionize the way we treat at least some of our patients with acne. They may both be effective for treating facial acne scars. Time will tell. Further study of both scarring and acne are needed to fully categorize the benefit and to optimize treatments.”
To date no direct clinical comparisons have been made between the AviClear and Accure devices.
Dr. Dover reported that he is a consultant for Cutera, the manufacturer for AviClear. He also performs research for the company.
PHOENIX – When Jeffrey Dover, MD, addressed audience members gathered for a session on cutting-edge technologies at the annual conference of the American Society for Laser Medicine and Surgery, he reflected on a conversation he had with R. Rox Anderson, MD, almost 40 years ago, about eventually finding a cure for acne.
“Despite the fact that we have over-the-counter therapies, prescription therapies, and all kinds of devices available to treat acne, there are still barriers to care that get in the way of treatment,” said Dr. Dover, director of SkinCare Physicians in Chestnut Hill, Mass. “If we had a device based on innovative light science that could meet the needs of the acne patient to get rid of these barriers, wouldn’t that be something wonderful?”
The answer to this question, he said, is now “yes,” because of advances in lasers that target sebaceous glands.
In a seminal paper published in 2012, Fernanda H. Sakamoto, MD, PhD, Dr. Anderson, and colleagues demonstrated the potential for a free electron laser to target sebaceous glands . Following several years of refinement, Dr. Dover said.
“With the 1,726-nm laser, there is some selective absorption in sebum in skin, which beats out absorption in the other chromophores,” he said. “But it’s not a big difference like it is, for example, for pulsed-dye lasers and vascular targets. ... This means that the therapeutic window is relatively small and protecting the rest of the epidermis and dermis is crucial to be able to target these lesions or the sebaceous gland without unnecessary damage. If we can protect the epidermis and heat just the sebaceous glands, we should be able to get Accutane-like results if we get durability [by] shrinking sebaceous glands.”
Effective cooling, whether contact cooling, bulk cooling, or air cooling, is crucial to success, he continued. “It’s got to be robust and highly specific to protect the skin, so you don’t end up with side effects that are worse than the disease.”
The AviClear laser delivers seven 3-mm spots, which takes into account the thermal relaxation times of the sebaceous glands. The algorithm delivers a treatment imprint at roughly 0.3 Hz and a 1.5-mm depth of penetration, and the device relies on contact cooling. In pivotal data submitted to the FDA, 104 individuals with moderate to severe acne received three treatments with the AviClear 1 month apart, with follow-up at 1, 3, 6, and 12 months post treatment. They had no other treatment regimens, and the primary endpoint was the percentage of patients who achieved a 50% reduction in inflammatory lesion count 3 months after the final treatment. The secondary endpoint was an Investigator’s Global Assessment (IGA) improvement of 2 or greater.
Dr. Dover, who helped design the study, said that, at 3 months, 80% of those treated achieved a 50% or greater reduction in inflammatory lesion count (P < .001). As for secondary endpoints, 36% of individuals were assessed as having clear or almost clear skin; 47% achieved a 2-point or greater improvement in IGA score, compared with baseline, and 87% achieved a 1-point or greater improvement in IGA score, compared with baseline. By 6 months, 88% of individuals achieved a 50% or greater reduction in inflammatory lesion count; this improved to 92% by 12 months (P < .001).
“All of these procedures were done with no topical anesthetic, no intralesional anesthetic, and they tolerated these quite well,” he said. “There was no down time that required medical intervention after the treatments. All posttreatment erythema and swelling resolved quickly,” and 75% of the patients were “very satisfied” with the treatments.
The Accure Laser System features a proprietary technology that precisely controls thermal gradient depth. “So instead of guessing whether you are delivering the correct amount of heat, it actually tells you,” said Dr. Dover, a past president of the ASLMS and the American Society for Dermatologic Surgery. “It correlates surface and at-depth temperatures, and there’s an infrared camera for real-time accurate temperature monitoring.” The device features highly controlled air cooling and a pulsing pattern that ensures treatment of sebaceous glands of all sizes and at all depths. The clinical end marker is peak epidermal temperature.
In a study supported by Accure, the manufacturer, researchers evaluated the efficacy of the Accure Laser System in 35 subjects with types I to VI skin, who received four monthly treatments 30-45 minutes each, and were followed 12, 26, 39, and 52 weeks following their last treatment. To date, data out to 52 weeks is available for 17 study participants. According to Dr. Dover, the researchers found 80% clearance at 12 weeks following the last treatment, with continued improvement at 52 weeks. One hundred percent of subjects responded. Side effects included erythema, edema, crusting, blisters, and inflammatory papules. “None of these were medically significant,” he said.
As dermatologists begin to incorporate the AviClear and Accure devices into their practices, Dr. Dover said that he is reminded of the conversation he had some 40 years ago with Dr. Anderson about finding a cure for acne, and he feels a bit awestruck. “These 1,726-nm lasers are effective for treating acne. I personally think they are going to revolutionize the way we treat at least some of our patients with acne. They may both be effective for treating facial acne scars. Time will tell. Further study of both scarring and acne are needed to fully categorize the benefit and to optimize treatments.”
To date no direct clinical comparisons have been made between the AviClear and Accure devices.
Dr. Dover reported that he is a consultant for Cutera, the manufacturer for AviClear. He also performs research for the company.
AT ASLMS 2023
Controlled hyperthermia: Novel treatment of BCCs without surgery continues to be refined
PHOENIX – .
“For 2,000 years, it’s been known that heat can kill cancers,” an apoptotic reaction “rather than a destructive reaction coming from excessive heat,” Christopher B. Zachary, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study was presented during an abstract session.
Dr. Zachary, professor and chair emeritus of the department of dermatology at the University of California, Irvine, and colleagues, evaluated a novel, noninvasive technique of controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular BCCs. For this prospective study, which was first described at the 2022 ASLMS annual conference and is being conducted at three centers, 73 patients with biopsy-proven superficial and nodular BCCs have been scanned with the VivoSight Dx optical coherence tomography (OCT) device to map BCC tumor margins.
The BCCs were treated with the Sciton 1,064-nm Er:YAG laser equipped with a 4-mm beam diameter scan pattern with no overlap and an 8-millisecond pulse duration, randomized to either standard 120-140 J/cm2 pulses until tissue graying and contraction was observed, or the CHAMP controlled hyperthermia technique using repeated 25 J/cm2 pulses under thermal camera imaging to maintain a consistent temperature of 55º C for 60 seconds. Patients were rescanned by OCT at 3 to 12 months for any signs of residual tumor and if positive, were retreated. Finally, lesions were excised for evidence of histological clearance.
To date, 48 patients have completed the study. Among the 26 patients treated with the CHAMP method, 22 (84.6%) were histologically clear, as were 19 of the 22 (86.4%) in the standard treatment group. Ulceration was uncommon with the CHAMP method, and patients healed with modest erythema, Dr. Zachary said.
Pretreatment OCT mapping of BCCs indicated that tumors extended beyond their 5-mm clinical margins in 11 cases (15%). “This will be of interest to those who treat BCCs by Mohs or standard excision,” he said. Increased vascularity measured by dynamic OCT was noted in most CHAMP patients immediately after irradiation, which suggests that apoptosis was the primary mechanism of tumor response instead of vascular destruction.
“The traditional technique for using the long pulsed 1,064-nm Er:YAG laser to cause damage and destruction of BCC is 120-140 J/cm2 at one or two passes until you get to an endpoint of graying and contraction of tissue,” Dr. Zachary said. “That’s opposed to the ‘Low and Slow’ approach [where you use] multiple pulses at 25 J/cm2 until you achieve an optimal time and temperature. If you treat above 60º C, you tend to get epidermal blistering, prolonged healing, and interestingly, absence of pain. I think that’s because you kill off the nerve fibers. With the low fluence multiple scan technique, you’re going for an even flat-top heating.”
Currently, he and his colleagues consider 55 degrees at 60 seconds as “the optimal parameters,” he said, but “it could be 45 degrees at 90 seconds or two minutes. We don’t know yet.”
In an interview at the meeting, one of the abstract session moderators, Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said that he was encouraged by the study results as investigations into effective, noninvasive treatment of BCC continue to move forward. “Details matter such as the temperature [of energy delivery] and noninvasive imaging to delineate the appropriate margins,” said Dr. Avram, who has conducted research on the 1,064-nm long-pulsed Nd:YAG laser as an alternative treatment for nonfacial BCCs in patients who are poor surgical candidates.
“Hopefully, at some point,” he said, such approaches will “become the standard of care for many BCCs that we are now treating surgically. I don’t think this will happen in the next 3 years, but I think in the long term, it will emerge as the treatment of choice.”
The study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Dr. Zachary reported having no relevant disclosures. Dr. Avram disclosed that he has received consulting fees from Sciton.
PHOENIX – .
“For 2,000 years, it’s been known that heat can kill cancers,” an apoptotic reaction “rather than a destructive reaction coming from excessive heat,” Christopher B. Zachary, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study was presented during an abstract session.
Dr. Zachary, professor and chair emeritus of the department of dermatology at the University of California, Irvine, and colleagues, evaluated a novel, noninvasive technique of controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular BCCs. For this prospective study, which was first described at the 2022 ASLMS annual conference and is being conducted at three centers, 73 patients with biopsy-proven superficial and nodular BCCs have been scanned with the VivoSight Dx optical coherence tomography (OCT) device to map BCC tumor margins.
The BCCs were treated with the Sciton 1,064-nm Er:YAG laser equipped with a 4-mm beam diameter scan pattern with no overlap and an 8-millisecond pulse duration, randomized to either standard 120-140 J/cm2 pulses until tissue graying and contraction was observed, or the CHAMP controlled hyperthermia technique using repeated 25 J/cm2 pulses under thermal camera imaging to maintain a consistent temperature of 55º C for 60 seconds. Patients were rescanned by OCT at 3 to 12 months for any signs of residual tumor and if positive, were retreated. Finally, lesions were excised for evidence of histological clearance.
To date, 48 patients have completed the study. Among the 26 patients treated with the CHAMP method, 22 (84.6%) were histologically clear, as were 19 of the 22 (86.4%) in the standard treatment group. Ulceration was uncommon with the CHAMP method, and patients healed with modest erythema, Dr. Zachary said.
Pretreatment OCT mapping of BCCs indicated that tumors extended beyond their 5-mm clinical margins in 11 cases (15%). “This will be of interest to those who treat BCCs by Mohs or standard excision,” he said. Increased vascularity measured by dynamic OCT was noted in most CHAMP patients immediately after irradiation, which suggests that apoptosis was the primary mechanism of tumor response instead of vascular destruction.
“The traditional technique for using the long pulsed 1,064-nm Er:YAG laser to cause damage and destruction of BCC is 120-140 J/cm2 at one or two passes until you get to an endpoint of graying and contraction of tissue,” Dr. Zachary said. “That’s opposed to the ‘Low and Slow’ approach [where you use] multiple pulses at 25 J/cm2 until you achieve an optimal time and temperature. If you treat above 60º C, you tend to get epidermal blistering, prolonged healing, and interestingly, absence of pain. I think that’s because you kill off the nerve fibers. With the low fluence multiple scan technique, you’re going for an even flat-top heating.”
Currently, he and his colleagues consider 55 degrees at 60 seconds as “the optimal parameters,” he said, but “it could be 45 degrees at 90 seconds or two minutes. We don’t know yet.”
In an interview at the meeting, one of the abstract session moderators, Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said that he was encouraged by the study results as investigations into effective, noninvasive treatment of BCC continue to move forward. “Details matter such as the temperature [of energy delivery] and noninvasive imaging to delineate the appropriate margins,” said Dr. Avram, who has conducted research on the 1,064-nm long-pulsed Nd:YAG laser as an alternative treatment for nonfacial BCCs in patients who are poor surgical candidates.
“Hopefully, at some point,” he said, such approaches will “become the standard of care for many BCCs that we are now treating surgically. I don’t think this will happen in the next 3 years, but I think in the long term, it will emerge as the treatment of choice.”
The study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Dr. Zachary reported having no relevant disclosures. Dr. Avram disclosed that he has received consulting fees from Sciton.
PHOENIX – .
“For 2,000 years, it’s been known that heat can kill cancers,” an apoptotic reaction “rather than a destructive reaction coming from excessive heat,” Christopher B. Zachary, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study was presented during an abstract session.
Dr. Zachary, professor and chair emeritus of the department of dermatology at the University of California, Irvine, and colleagues, evaluated a novel, noninvasive technique of controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular BCCs. For this prospective study, which was first described at the 2022 ASLMS annual conference and is being conducted at three centers, 73 patients with biopsy-proven superficial and nodular BCCs have been scanned with the VivoSight Dx optical coherence tomography (OCT) device to map BCC tumor margins.
The BCCs were treated with the Sciton 1,064-nm Er:YAG laser equipped with a 4-mm beam diameter scan pattern with no overlap and an 8-millisecond pulse duration, randomized to either standard 120-140 J/cm2 pulses until tissue graying and contraction was observed, or the CHAMP controlled hyperthermia technique using repeated 25 J/cm2 pulses under thermal camera imaging to maintain a consistent temperature of 55º C for 60 seconds. Patients were rescanned by OCT at 3 to 12 months for any signs of residual tumor and if positive, were retreated. Finally, lesions were excised for evidence of histological clearance.
To date, 48 patients have completed the study. Among the 26 patients treated with the CHAMP method, 22 (84.6%) were histologically clear, as were 19 of the 22 (86.4%) in the standard treatment group. Ulceration was uncommon with the CHAMP method, and patients healed with modest erythema, Dr. Zachary said.
Pretreatment OCT mapping of BCCs indicated that tumors extended beyond their 5-mm clinical margins in 11 cases (15%). “This will be of interest to those who treat BCCs by Mohs or standard excision,” he said. Increased vascularity measured by dynamic OCT was noted in most CHAMP patients immediately after irradiation, which suggests that apoptosis was the primary mechanism of tumor response instead of vascular destruction.
“The traditional technique for using the long pulsed 1,064-nm Er:YAG laser to cause damage and destruction of BCC is 120-140 J/cm2 at one or two passes until you get to an endpoint of graying and contraction of tissue,” Dr. Zachary said. “That’s opposed to the ‘Low and Slow’ approach [where you use] multiple pulses at 25 J/cm2 until you achieve an optimal time and temperature. If you treat above 60º C, you tend to get epidermal blistering, prolonged healing, and interestingly, absence of pain. I think that’s because you kill off the nerve fibers. With the low fluence multiple scan technique, you’re going for an even flat-top heating.”
Currently, he and his colleagues consider 55 degrees at 60 seconds as “the optimal parameters,” he said, but “it could be 45 degrees at 90 seconds or two minutes. We don’t know yet.”
In an interview at the meeting, one of the abstract session moderators, Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said that he was encouraged by the study results as investigations into effective, noninvasive treatment of BCC continue to move forward. “Details matter such as the temperature [of energy delivery] and noninvasive imaging to delineate the appropriate margins,” said Dr. Avram, who has conducted research on the 1,064-nm long-pulsed Nd:YAG laser as an alternative treatment for nonfacial BCCs in patients who are poor surgical candidates.
“Hopefully, at some point,” he said, such approaches will “become the standard of care for many BCCs that we are now treating surgically. I don’t think this will happen in the next 3 years, but I think in the long term, it will emerge as the treatment of choice.”
The study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Dr. Zachary reported having no relevant disclosures. Dr. Avram disclosed that he has received consulting fees from Sciton.
AT ASLMS 2023
Best practices document outlines genitourinary applications of lasers and energy-based devices
PHOENIX –
“Even a cursory review of PubMed today yields over 100,000 results” on this topic, Macrene R. Alexiades, MD, PhD, associate clinical professor of dermatology at Yale University, New Haven, Conn., said at the annual conference of the American Society for Laser Medicine and Surgery. “Add to that radiofrequency and various diagnoses, the number of publications has skyrocketed, particularly over the last 10 years.”
What has been missing from this hot research topic all these years, she continued, is that no one has distilled this pile of data into a practical guide for office-based clinicians who use lasers and energy-based devices for genitourinary conditions – until now. Working with experts in gynecology and urogynecology, Dr. Alexiades spearheaded a 2-year-long effort to assemble a document on optimal protocols and best practices for genitourinary application of lasers and energy-based devices. The document, published soon after the ASLMS meeting in Lasers in Medicine and Surgery, includes a table that lists the current Food and Drug Administration approval status of devices in genitourinary applications, as well as individual sections dedicated to fractional lasers, radiofrequency (RF) devices, and high-intensity focused electromagnetic technology. It concludes with a section on the current status of clearances and future pathways.
“The work we did was exhaustive,” said Dr. Alexiades, who is also founder and director of Dermatology & Laser Surgery Center of New York. “We went through all the clinical trial data and compiled the parameters that, as a consensus, we agree are best practices for each technology for which we had rigorous published data.”
The document contains a brief background on the history of the devices used for genitourinary issues and it addresses core topics for each technology, such as conditions treated, contraindications, preoperative physical assessment and preparation, perioperative protocols, and postoperative care.
Contraindications to the genitourinary use of lasers and energy-based devices are numerous and include use of an intrauterine device, active urinary tract or genital infection, vaginal bleeding, current pregnancy, active or recent malignancy, having an electrical implant anywhere in the body, significant concurrent illness, and an anticoagulative or thromboembolic condition or taking anticoagulant medications 1 week prior to the procedure. Another condition to screen for is advanced prolapse, which was considered a contraindication in all clinical trials, she added. “It’s important that you’re able to do the speculum exam and stage the prolapse” so that a patient with this contraindication is not treated.
Dr. Alexiades shared the following highlights from the document’s section related to the use of fractional CO2 lasers:
Preoperative management. Schedule the treatment one week after the patient’s menstrual period. Patients should avoid blood thinners for 7 days and avoid intercourse the night before the procedure. Reschedule in the case of fever, chills, or vaginal bleeding or discharge.
Preoperative physical exam and testing. A normal speculum exam and a recent negative PAP smear are required. For those of child-bearing potential, a pregnancy test is warranted. Obtain written and verbal consent, including discussion of all treatment options, risks, and benefits. No topical or local anesthesia is necessary internally. “Externally, we sometimes apply topical lidocaine gel, but I have found that’s not necessary in most cases,” Dr. Alexiades said. “The treatment is so quick.”
Peri-operative management. In general, device settings are provided by the manufacturer. “For most of the studies that had successful outcomes and no adverse events, researchers adhered to the mild or moderate settings on the technology,” she said. Energy settings were between 15 and 30 watts, delivered at a laser fluence of about 250-300 mJ/cm2 with a spacing of microbeams 1 mm apart. Typically, three treatments are done at 1-month intervals and maintenance treatments are recommended at 6 and 12 months based on duration of the outcomes.
Vulvovaginal postoperative management. A 3-day recovery time is recommended with avoidance of intercourse during this period, because “re-epithelialization is usually complete in 3 days, so we want to give the opportunity for the lining to heal prior to introducing any friction, Dr. Alexiades said.” Rarely, spotting or discharge may occur and there should be no discomfort. “Any severe discomfort or burning may potentially signify infection and should prompt evaluation and possibly vaginal cultures. The patient can shower, but we recommend avoiding seated baths to decrease any introduction of infectious agents.”
Patients should be followed up monthly until three treatments are completed, and a maintenance treatment is considered appropriate between 6 and 12 months. “I do recommend doing a 1-month follow-up following the final treatment, unless it’s a patient who has already had a series of three treatments and is coming in for maintenance,” she said.
In a study from her own practice, Dr. Alexiades evaluated a series of three fractional CO2 laser treatments to the vulva and vagina with a 1-year follow-up in postmenopausal patients. She used the Vaginal Health Index (VHI) to assess changes in vaginal elasticity, fluid volume, vaginal pH, epithelial integrity, and moisture. She and her colleagues discovered that there was improvement in every VHI category after treatment and during the follow-up interval up to 6 months.
“Between 6 and 12 months, we started to see a return a bit toward baseline on all of these parameters,” she said. “The serendipitous discovery that I made during the course of that study was that early intervention improves outcomes. I observed that the younger, most recently postmenopausal cohort seemed to attain normal or near normal VHI quicker than the more extended postmenopausal cohorts.”
In an editorial published in 2020, Dr. Alexiades reviewed the effects of fractional CO2 laser treatment of vulvar skin on vaginal pH and referred to a study she conducted that found that the mean baseline pH pretreatment was 6.32 in the cohort of postmenopausal patients, and was reduced after 3 treatments. “Postmenopausally, the normal acidic pH becomes alkaline,” she said. But she did not expect to see an additional reduction in pH following the treatment out to 6 months. “This indicates that, whatever the wound healing and other restorative effects of these devices are, they seem to continue out to 6 months, at which point it turns around and moves toward baseline [levels].”
Dr. Alexiades highlighted two published meta-analyses of studies related to the genitourinary use of lasers and energy-based devices. One included 59 studies of 3,609 women treated for vaginal rejuvenation using either radiofrequency or fractional ablative laser therapy. The studies reported improvements in symptoms of GSM/VVA and sexual function, high patient satisfaction, with minor adverse events, including treatment-associated vaginal swelling or vaginal discharge.
“Further research needs to be completed to determine which specific pathologies can be treated, if maintenance treatment is necessary, and long-term safety concerns,” the authors concluded.
In another review, researchers analyzed 64 studies related to vaginal laser therapy for GSM. Of these, 47 were before and after studies without a control group, 10 were controlled intervention studies, and 7 were observational cohort and cross-sectional studies.
Vaginal laser treatment “seems to improve scores on the visual analogue scale, Female Sexual Function Index, and the Vaginal Health Index over the short term,” the authors wrote. “Safety outcomes are underreported and short term. Further well-designed clinical trials with sham-laser control groups and evaluating objective variables are needed to provide the best evidence on efficacy.”
“Lasers and energy-based devices are now considered alternative therapeutic modalities for genitourinary conditions,” Dr. Alexiades concluded. “The shortcomings in the literature with respect to lasers and device treatments demonstrate the need for the consensus on best practices and protocols.”
During a separate presentation at the meeting, Michael Gold, MD, highlighted data from Grand View Research, a market research database, which estimated that the global women’s health and wellness market is valued at more than $31 billion globally and is expected to grow at a compound annual growth rate of 4.8% from 2022 to 2030.
“Sales of women’s health energy-based devices continue to grow as new technologies are developed,” said Dr. Gold, a Nashville, Tenn.–based dermatologist and cosmetic surgeon who is also editor-in-chief of the Journal of Cosmetic Dermatology. “Evolving societal norms have made discussions about feminine health issues acceptable. Suffering in silence is no longer necessary or advocated.”
Dr. Alexiades disclosed that she has conducted research for Candela Lasers, Lumenis, Allergan/AbbVie, InMode, and Endymed. She is also the founder and CEO of Macrene Actives. Dr. Gold disclosed that he is a consultant to and/or an investigator and a speaker for Joylux, InMode, and Alma Lasers.
PHOENIX –
“Even a cursory review of PubMed today yields over 100,000 results” on this topic, Macrene R. Alexiades, MD, PhD, associate clinical professor of dermatology at Yale University, New Haven, Conn., said at the annual conference of the American Society for Laser Medicine and Surgery. “Add to that radiofrequency and various diagnoses, the number of publications has skyrocketed, particularly over the last 10 years.”
What has been missing from this hot research topic all these years, she continued, is that no one has distilled this pile of data into a practical guide for office-based clinicians who use lasers and energy-based devices for genitourinary conditions – until now. Working with experts in gynecology and urogynecology, Dr. Alexiades spearheaded a 2-year-long effort to assemble a document on optimal protocols and best practices for genitourinary application of lasers and energy-based devices. The document, published soon after the ASLMS meeting in Lasers in Medicine and Surgery, includes a table that lists the current Food and Drug Administration approval status of devices in genitourinary applications, as well as individual sections dedicated to fractional lasers, radiofrequency (RF) devices, and high-intensity focused electromagnetic technology. It concludes with a section on the current status of clearances and future pathways.
“The work we did was exhaustive,” said Dr. Alexiades, who is also founder and director of Dermatology & Laser Surgery Center of New York. “We went through all the clinical trial data and compiled the parameters that, as a consensus, we agree are best practices for each technology for which we had rigorous published data.”
The document contains a brief background on the history of the devices used for genitourinary issues and it addresses core topics for each technology, such as conditions treated, contraindications, preoperative physical assessment and preparation, perioperative protocols, and postoperative care.
Contraindications to the genitourinary use of lasers and energy-based devices are numerous and include use of an intrauterine device, active urinary tract or genital infection, vaginal bleeding, current pregnancy, active or recent malignancy, having an electrical implant anywhere in the body, significant concurrent illness, and an anticoagulative or thromboembolic condition or taking anticoagulant medications 1 week prior to the procedure. Another condition to screen for is advanced prolapse, which was considered a contraindication in all clinical trials, she added. “It’s important that you’re able to do the speculum exam and stage the prolapse” so that a patient with this contraindication is not treated.
Dr. Alexiades shared the following highlights from the document’s section related to the use of fractional CO2 lasers:
Preoperative management. Schedule the treatment one week after the patient’s menstrual period. Patients should avoid blood thinners for 7 days and avoid intercourse the night before the procedure. Reschedule in the case of fever, chills, or vaginal bleeding or discharge.
Preoperative physical exam and testing. A normal speculum exam and a recent negative PAP smear are required. For those of child-bearing potential, a pregnancy test is warranted. Obtain written and verbal consent, including discussion of all treatment options, risks, and benefits. No topical or local anesthesia is necessary internally. “Externally, we sometimes apply topical lidocaine gel, but I have found that’s not necessary in most cases,” Dr. Alexiades said. “The treatment is so quick.”
Peri-operative management. In general, device settings are provided by the manufacturer. “For most of the studies that had successful outcomes and no adverse events, researchers adhered to the mild or moderate settings on the technology,” she said. Energy settings were between 15 and 30 watts, delivered at a laser fluence of about 250-300 mJ/cm2 with a spacing of microbeams 1 mm apart. Typically, three treatments are done at 1-month intervals and maintenance treatments are recommended at 6 and 12 months based on duration of the outcomes.
Vulvovaginal postoperative management. A 3-day recovery time is recommended with avoidance of intercourse during this period, because “re-epithelialization is usually complete in 3 days, so we want to give the opportunity for the lining to heal prior to introducing any friction, Dr. Alexiades said.” Rarely, spotting or discharge may occur and there should be no discomfort. “Any severe discomfort or burning may potentially signify infection and should prompt evaluation and possibly vaginal cultures. The patient can shower, but we recommend avoiding seated baths to decrease any introduction of infectious agents.”
Patients should be followed up monthly until three treatments are completed, and a maintenance treatment is considered appropriate between 6 and 12 months. “I do recommend doing a 1-month follow-up following the final treatment, unless it’s a patient who has already had a series of three treatments and is coming in for maintenance,” she said.
In a study from her own practice, Dr. Alexiades evaluated a series of three fractional CO2 laser treatments to the vulva and vagina with a 1-year follow-up in postmenopausal patients. She used the Vaginal Health Index (VHI) to assess changes in vaginal elasticity, fluid volume, vaginal pH, epithelial integrity, and moisture. She and her colleagues discovered that there was improvement in every VHI category after treatment and during the follow-up interval up to 6 months.
“Between 6 and 12 months, we started to see a return a bit toward baseline on all of these parameters,” she said. “The serendipitous discovery that I made during the course of that study was that early intervention improves outcomes. I observed that the younger, most recently postmenopausal cohort seemed to attain normal or near normal VHI quicker than the more extended postmenopausal cohorts.”
In an editorial published in 2020, Dr. Alexiades reviewed the effects of fractional CO2 laser treatment of vulvar skin on vaginal pH and referred to a study she conducted that found that the mean baseline pH pretreatment was 6.32 in the cohort of postmenopausal patients, and was reduced after 3 treatments. “Postmenopausally, the normal acidic pH becomes alkaline,” she said. But she did not expect to see an additional reduction in pH following the treatment out to 6 months. “This indicates that, whatever the wound healing and other restorative effects of these devices are, they seem to continue out to 6 months, at which point it turns around and moves toward baseline [levels].”
Dr. Alexiades highlighted two published meta-analyses of studies related to the genitourinary use of lasers and energy-based devices. One included 59 studies of 3,609 women treated for vaginal rejuvenation using either radiofrequency or fractional ablative laser therapy. The studies reported improvements in symptoms of GSM/VVA and sexual function, high patient satisfaction, with minor adverse events, including treatment-associated vaginal swelling or vaginal discharge.
“Further research needs to be completed to determine which specific pathologies can be treated, if maintenance treatment is necessary, and long-term safety concerns,” the authors concluded.
In another review, researchers analyzed 64 studies related to vaginal laser therapy for GSM. Of these, 47 were before and after studies without a control group, 10 were controlled intervention studies, and 7 were observational cohort and cross-sectional studies.
Vaginal laser treatment “seems to improve scores on the visual analogue scale, Female Sexual Function Index, and the Vaginal Health Index over the short term,” the authors wrote. “Safety outcomes are underreported and short term. Further well-designed clinical trials with sham-laser control groups and evaluating objective variables are needed to provide the best evidence on efficacy.”
“Lasers and energy-based devices are now considered alternative therapeutic modalities for genitourinary conditions,” Dr. Alexiades concluded. “The shortcomings in the literature with respect to lasers and device treatments demonstrate the need for the consensus on best practices and protocols.”
During a separate presentation at the meeting, Michael Gold, MD, highlighted data from Grand View Research, a market research database, which estimated that the global women’s health and wellness market is valued at more than $31 billion globally and is expected to grow at a compound annual growth rate of 4.8% from 2022 to 2030.
“Sales of women’s health energy-based devices continue to grow as new technologies are developed,” said Dr. Gold, a Nashville, Tenn.–based dermatologist and cosmetic surgeon who is also editor-in-chief of the Journal of Cosmetic Dermatology. “Evolving societal norms have made discussions about feminine health issues acceptable. Suffering in silence is no longer necessary or advocated.”
Dr. Alexiades disclosed that she has conducted research for Candela Lasers, Lumenis, Allergan/AbbVie, InMode, and Endymed. She is also the founder and CEO of Macrene Actives. Dr. Gold disclosed that he is a consultant to and/or an investigator and a speaker for Joylux, InMode, and Alma Lasers.
PHOENIX –
“Even a cursory review of PubMed today yields over 100,000 results” on this topic, Macrene R. Alexiades, MD, PhD, associate clinical professor of dermatology at Yale University, New Haven, Conn., said at the annual conference of the American Society for Laser Medicine and Surgery. “Add to that radiofrequency and various diagnoses, the number of publications has skyrocketed, particularly over the last 10 years.”
What has been missing from this hot research topic all these years, she continued, is that no one has distilled this pile of data into a practical guide for office-based clinicians who use lasers and energy-based devices for genitourinary conditions – until now. Working with experts in gynecology and urogynecology, Dr. Alexiades spearheaded a 2-year-long effort to assemble a document on optimal protocols and best practices for genitourinary application of lasers and energy-based devices. The document, published soon after the ASLMS meeting in Lasers in Medicine and Surgery, includes a table that lists the current Food and Drug Administration approval status of devices in genitourinary applications, as well as individual sections dedicated to fractional lasers, radiofrequency (RF) devices, and high-intensity focused electromagnetic technology. It concludes with a section on the current status of clearances and future pathways.
“The work we did was exhaustive,” said Dr. Alexiades, who is also founder and director of Dermatology & Laser Surgery Center of New York. “We went through all the clinical trial data and compiled the parameters that, as a consensus, we agree are best practices for each technology for which we had rigorous published data.”
The document contains a brief background on the history of the devices used for genitourinary issues and it addresses core topics for each technology, such as conditions treated, contraindications, preoperative physical assessment and preparation, perioperative protocols, and postoperative care.
Contraindications to the genitourinary use of lasers and energy-based devices are numerous and include use of an intrauterine device, active urinary tract or genital infection, vaginal bleeding, current pregnancy, active or recent malignancy, having an electrical implant anywhere in the body, significant concurrent illness, and an anticoagulative or thromboembolic condition or taking anticoagulant medications 1 week prior to the procedure. Another condition to screen for is advanced prolapse, which was considered a contraindication in all clinical trials, she added. “It’s important that you’re able to do the speculum exam and stage the prolapse” so that a patient with this contraindication is not treated.
Dr. Alexiades shared the following highlights from the document’s section related to the use of fractional CO2 lasers:
Preoperative management. Schedule the treatment one week after the patient’s menstrual period. Patients should avoid blood thinners for 7 days and avoid intercourse the night before the procedure. Reschedule in the case of fever, chills, or vaginal bleeding or discharge.
Preoperative physical exam and testing. A normal speculum exam and a recent negative PAP smear are required. For those of child-bearing potential, a pregnancy test is warranted. Obtain written and verbal consent, including discussion of all treatment options, risks, and benefits. No topical or local anesthesia is necessary internally. “Externally, we sometimes apply topical lidocaine gel, but I have found that’s not necessary in most cases,” Dr. Alexiades said. “The treatment is so quick.”
Peri-operative management. In general, device settings are provided by the manufacturer. “For most of the studies that had successful outcomes and no adverse events, researchers adhered to the mild or moderate settings on the technology,” she said. Energy settings were between 15 and 30 watts, delivered at a laser fluence of about 250-300 mJ/cm2 with a spacing of microbeams 1 mm apart. Typically, three treatments are done at 1-month intervals and maintenance treatments are recommended at 6 and 12 months based on duration of the outcomes.
Vulvovaginal postoperative management. A 3-day recovery time is recommended with avoidance of intercourse during this period, because “re-epithelialization is usually complete in 3 days, so we want to give the opportunity for the lining to heal prior to introducing any friction, Dr. Alexiades said.” Rarely, spotting or discharge may occur and there should be no discomfort. “Any severe discomfort or burning may potentially signify infection and should prompt evaluation and possibly vaginal cultures. The patient can shower, but we recommend avoiding seated baths to decrease any introduction of infectious agents.”
Patients should be followed up monthly until three treatments are completed, and a maintenance treatment is considered appropriate between 6 and 12 months. “I do recommend doing a 1-month follow-up following the final treatment, unless it’s a patient who has already had a series of three treatments and is coming in for maintenance,” she said.
In a study from her own practice, Dr. Alexiades evaluated a series of three fractional CO2 laser treatments to the vulva and vagina with a 1-year follow-up in postmenopausal patients. She used the Vaginal Health Index (VHI) to assess changes in vaginal elasticity, fluid volume, vaginal pH, epithelial integrity, and moisture. She and her colleagues discovered that there was improvement in every VHI category after treatment and during the follow-up interval up to 6 months.
“Between 6 and 12 months, we started to see a return a bit toward baseline on all of these parameters,” she said. “The serendipitous discovery that I made during the course of that study was that early intervention improves outcomes. I observed that the younger, most recently postmenopausal cohort seemed to attain normal or near normal VHI quicker than the more extended postmenopausal cohorts.”
In an editorial published in 2020, Dr. Alexiades reviewed the effects of fractional CO2 laser treatment of vulvar skin on vaginal pH and referred to a study she conducted that found that the mean baseline pH pretreatment was 6.32 in the cohort of postmenopausal patients, and was reduced after 3 treatments. “Postmenopausally, the normal acidic pH becomes alkaline,” she said. But she did not expect to see an additional reduction in pH following the treatment out to 6 months. “This indicates that, whatever the wound healing and other restorative effects of these devices are, they seem to continue out to 6 months, at which point it turns around and moves toward baseline [levels].”
Dr. Alexiades highlighted two published meta-analyses of studies related to the genitourinary use of lasers and energy-based devices. One included 59 studies of 3,609 women treated for vaginal rejuvenation using either radiofrequency or fractional ablative laser therapy. The studies reported improvements in symptoms of GSM/VVA and sexual function, high patient satisfaction, with minor adverse events, including treatment-associated vaginal swelling or vaginal discharge.
“Further research needs to be completed to determine which specific pathologies can be treated, if maintenance treatment is necessary, and long-term safety concerns,” the authors concluded.
In another review, researchers analyzed 64 studies related to vaginal laser therapy for GSM. Of these, 47 were before and after studies without a control group, 10 were controlled intervention studies, and 7 were observational cohort and cross-sectional studies.
Vaginal laser treatment “seems to improve scores on the visual analogue scale, Female Sexual Function Index, and the Vaginal Health Index over the short term,” the authors wrote. “Safety outcomes are underreported and short term. Further well-designed clinical trials with sham-laser control groups and evaluating objective variables are needed to provide the best evidence on efficacy.”
“Lasers and energy-based devices are now considered alternative therapeutic modalities for genitourinary conditions,” Dr. Alexiades concluded. “The shortcomings in the literature with respect to lasers and device treatments demonstrate the need for the consensus on best practices and protocols.”
During a separate presentation at the meeting, Michael Gold, MD, highlighted data from Grand View Research, a market research database, which estimated that the global women’s health and wellness market is valued at more than $31 billion globally and is expected to grow at a compound annual growth rate of 4.8% from 2022 to 2030.
“Sales of women’s health energy-based devices continue to grow as new technologies are developed,” said Dr. Gold, a Nashville, Tenn.–based dermatologist and cosmetic surgeon who is also editor-in-chief of the Journal of Cosmetic Dermatology. “Evolving societal norms have made discussions about feminine health issues acceptable. Suffering in silence is no longer necessary or advocated.”
Dr. Alexiades disclosed that she has conducted research for Candela Lasers, Lumenis, Allergan/AbbVie, InMode, and Endymed. She is also the founder and CEO of Macrene Actives. Dr. Gold disclosed that he is a consultant to and/or an investigator and a speaker for Joylux, InMode, and Alma Lasers.
AT ASLMS 2023
Could combining topical antioxidants with a nonablative laser prevent acne scars?
PHOENIX – lesions, results from a prospective, single-center study showed.
“Acne vulgaris is the most common inflammatory dermatosis worldwide, often resulting in sequelae such as scarring, PIE, and PIH,” presenting author Jamie Hu, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study results were presented during an abstract session. “This dyschromia can cause greater psychological distress than the original acne lesions, and disproportionately affects skin of color patients.”
Blemish-prone skin is known to have higher levels of sebum and lower levels of antioxidants, leading to lipid peroxidation and oxidative stress, resulting in proliferation of Cutibacterium acnes and an inflammatory cascade that has recently been implicated in postinflammatory dyschromia and the development of PIE and PIH, noted Dr. Hu, a dermatology resident at the University of Miami. “Therefore, the use of antioxidants presents an opportunity to disrupt blemish and dyschromia,” she said.
One such antioxidant is silymarin, which is derived from the milk thistle plant. Recent studies have demonstrated that silymarin reduces proinflammatory mediators, prevents lipid peroxidation, and presents a new way to target the treatment of both acne and postinflammatory dyschromia.
Dr. Hu’s mentor, Jill S. Waibel, MD, owner and medical director of the Miami Dermatology and Laser Institute, hypothesized that nonablative laser therapy followed by topical application of silymarin would improve acne-associated postinflammatory dyschromia. To test her hunch, she conducted a 12-week, prospective trial in which 24 patients with PIE and/or PIH were randomized to one of two treatment arms: laser treatment with topical antioxidants or laser treatment with vehicle control. Patients received three laser treatments, each 1 month apart. The topical antioxidant used was Silymarin CF, a serum that contains 0.5% silymarin, 0.5% salicylic acid, 15% L-ascorbic acid, and 0.5% ferulic acid. (The study was sponsored by SkinCeuticals, the manufacturer of the serum.)
Laser selection was made primarily on the type of dyschromia, with PIE patients receiving treatment with the pulsed dye laser and PIH patients receiving treatment with the 1,927-nm thulium laser. Patients were treated on days 0, 28, and 56 of the 12-week study, followed by immediate application of topical antioxidants or vehicle control. They were also instructed to apply the assigned topical twice daily for the duration of the study. Patients ranged in age from 21 to 61 years, and 20 had skin types III-IV.
To evaluate efficacy, the researchers conducted blinded clinical assessments with the postacne hyperpigmentation index (PAHPI) and the Global Aesthetic Improvement Scale (GAIS), instrumentation with the Mexameter, a device that captures erythema and melanin index values, and visual diagnostics with optical coherence tomography (OCT).
Dr. Hu reported that at week 12, the PAHPI in the silymarin-plus-laser treatment group fell from an average of 3.18 to 1.74 (a decrease of 1.44), which suggested an improvement trend, compared with the laser treatment–only group, whose PAHPI fell from an average of 3.25 to 1.97 (a decrease of 1.28).
As for the GAIS, a one-time score assessed at the end of the trial, the average score for all patients was 3.24, which translated to “much improved/very much improved.” Patients in the silymarin-plus-laser treatment group had higher average scores compared with patients in the laser treatment–only group (3.35 vs. 3.10, respectively), but the differences did not reach statistical significance.
According to results of the Mexameter assessment, paired t-tests showed that the levels of intralesional melanin decreased significantly for patients in the silymarin-plus-laser treatment group, compared with the laser treatment–only group (P < .05). OCT assessments demonstrated an increase in dermal brightness in both groups, corresponding to an increase in dermal collagen, as well as an increase in blood vessel density.
In an interview at the meeting, Dr. Waibel, subsection chief of dermatology at Baptist Hospital of Miami, said that future studies will focus on long-term follow-up to determine if acne scars can be prevented by combining silymarin with lasers to prevent PIH and PIE. “That would be priceless,” she said. “I believe that the PIH is what causes damage to the collagen, and that damage to the collagen is what causes the scarring. So, if we can prevent or treat PIH, we may be able to prevent scarring.”
This approach, she added, “would decrease the pharmaceutical cost because I think there are many dermatologists who are treating PEI and PIH as active acne. You really have to have a keen eye for understanding the differences and you really have to be looking, because PIE and PIH are flat, whereas active acne consists of either comedones or nodules.”
She noted that in skin of color patients, she has seen PIH persist for 9 or 10 months after treatment with isotretinoin. “It’s not the isotretinoin causing the scars, or even the acne, it’s the prolonged inflammation,” she said.
Catherine M. DiGiorgio, MD, a Boston-based laser and cosmetic dermatologist who was asked to comment on the study, said that patients and dermatologists frequently seek alternatives to hydroquinone for unwanted hyperpigmentation.
“This topical contains an active ingredient – silymarin – obtained from the milk thistle plant along with several already well known topicals used for the treatment of acne and PIH,” said Dr. DiGiorgio, program co-chair of the 2023 ASLMS conference. “Further and larger studies are needed to demonstrate and support the effectiveness of this product and silymarin for PIH and/or PIE.”
Also commenting on the results, Ray Jalian, MD, a Los Angeles–based laser and cosmetic dermatologist, told this news organization that the study findings demonstrate the power of combining topical and laser treatment for more effective improvement in acne-related PIH.
“While the study failed to show statistically significant improvement in postinflammatory erythema with concomitant laser and topical therapy versus laser alone, the promising data supporting concurrent use of topicals and fractional lasers for treatment of PIH, particularly in dark skin phototypes, is a clinically impactful contribution to our daily practice,” he said.
Dr. Waibel disclosed that she has conducted clinical trials for many device and pharmaceutical companies including SkinCeuticals. Dr. Hu, Dr. DiGiorgio, and Dr. Jalian were not involved with the study and reported having no relevant disclosures.
PHOENIX – lesions, results from a prospective, single-center study showed.
“Acne vulgaris is the most common inflammatory dermatosis worldwide, often resulting in sequelae such as scarring, PIE, and PIH,” presenting author Jamie Hu, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study results were presented during an abstract session. “This dyschromia can cause greater psychological distress than the original acne lesions, and disproportionately affects skin of color patients.”
Blemish-prone skin is known to have higher levels of sebum and lower levels of antioxidants, leading to lipid peroxidation and oxidative stress, resulting in proliferation of Cutibacterium acnes and an inflammatory cascade that has recently been implicated in postinflammatory dyschromia and the development of PIE and PIH, noted Dr. Hu, a dermatology resident at the University of Miami. “Therefore, the use of antioxidants presents an opportunity to disrupt blemish and dyschromia,” she said.
One such antioxidant is silymarin, which is derived from the milk thistle plant. Recent studies have demonstrated that silymarin reduces proinflammatory mediators, prevents lipid peroxidation, and presents a new way to target the treatment of both acne and postinflammatory dyschromia.
Dr. Hu’s mentor, Jill S. Waibel, MD, owner and medical director of the Miami Dermatology and Laser Institute, hypothesized that nonablative laser therapy followed by topical application of silymarin would improve acne-associated postinflammatory dyschromia. To test her hunch, she conducted a 12-week, prospective trial in which 24 patients with PIE and/or PIH were randomized to one of two treatment arms: laser treatment with topical antioxidants or laser treatment with vehicle control. Patients received three laser treatments, each 1 month apart. The topical antioxidant used was Silymarin CF, a serum that contains 0.5% silymarin, 0.5% salicylic acid, 15% L-ascorbic acid, and 0.5% ferulic acid. (The study was sponsored by SkinCeuticals, the manufacturer of the serum.)
Laser selection was made primarily on the type of dyschromia, with PIE patients receiving treatment with the pulsed dye laser and PIH patients receiving treatment with the 1,927-nm thulium laser. Patients were treated on days 0, 28, and 56 of the 12-week study, followed by immediate application of topical antioxidants or vehicle control. They were also instructed to apply the assigned topical twice daily for the duration of the study. Patients ranged in age from 21 to 61 years, and 20 had skin types III-IV.
To evaluate efficacy, the researchers conducted blinded clinical assessments with the postacne hyperpigmentation index (PAHPI) and the Global Aesthetic Improvement Scale (GAIS), instrumentation with the Mexameter, a device that captures erythema and melanin index values, and visual diagnostics with optical coherence tomography (OCT).
Dr. Hu reported that at week 12, the PAHPI in the silymarin-plus-laser treatment group fell from an average of 3.18 to 1.74 (a decrease of 1.44), which suggested an improvement trend, compared with the laser treatment–only group, whose PAHPI fell from an average of 3.25 to 1.97 (a decrease of 1.28).
As for the GAIS, a one-time score assessed at the end of the trial, the average score for all patients was 3.24, which translated to “much improved/very much improved.” Patients in the silymarin-plus-laser treatment group had higher average scores compared with patients in the laser treatment–only group (3.35 vs. 3.10, respectively), but the differences did not reach statistical significance.
According to results of the Mexameter assessment, paired t-tests showed that the levels of intralesional melanin decreased significantly for patients in the silymarin-plus-laser treatment group, compared with the laser treatment–only group (P < .05). OCT assessments demonstrated an increase in dermal brightness in both groups, corresponding to an increase in dermal collagen, as well as an increase in blood vessel density.
In an interview at the meeting, Dr. Waibel, subsection chief of dermatology at Baptist Hospital of Miami, said that future studies will focus on long-term follow-up to determine if acne scars can be prevented by combining silymarin with lasers to prevent PIH and PIE. “That would be priceless,” she said. “I believe that the PIH is what causes damage to the collagen, and that damage to the collagen is what causes the scarring. So, if we can prevent or treat PIH, we may be able to prevent scarring.”
This approach, she added, “would decrease the pharmaceutical cost because I think there are many dermatologists who are treating PEI and PIH as active acne. You really have to have a keen eye for understanding the differences and you really have to be looking, because PIE and PIH are flat, whereas active acne consists of either comedones or nodules.”
She noted that in skin of color patients, she has seen PIH persist for 9 or 10 months after treatment with isotretinoin. “It’s not the isotretinoin causing the scars, or even the acne, it’s the prolonged inflammation,” she said.
Catherine M. DiGiorgio, MD, a Boston-based laser and cosmetic dermatologist who was asked to comment on the study, said that patients and dermatologists frequently seek alternatives to hydroquinone for unwanted hyperpigmentation.
“This topical contains an active ingredient – silymarin – obtained from the milk thistle plant along with several already well known topicals used for the treatment of acne and PIH,” said Dr. DiGiorgio, program co-chair of the 2023 ASLMS conference. “Further and larger studies are needed to demonstrate and support the effectiveness of this product and silymarin for PIH and/or PIE.”
Also commenting on the results, Ray Jalian, MD, a Los Angeles–based laser and cosmetic dermatologist, told this news organization that the study findings demonstrate the power of combining topical and laser treatment for more effective improvement in acne-related PIH.
“While the study failed to show statistically significant improvement in postinflammatory erythema with concomitant laser and topical therapy versus laser alone, the promising data supporting concurrent use of topicals and fractional lasers for treatment of PIH, particularly in dark skin phototypes, is a clinically impactful contribution to our daily practice,” he said.
Dr. Waibel disclosed that she has conducted clinical trials for many device and pharmaceutical companies including SkinCeuticals. Dr. Hu, Dr. DiGiorgio, and Dr. Jalian were not involved with the study and reported having no relevant disclosures.
PHOENIX – lesions, results from a prospective, single-center study showed.
“Acne vulgaris is the most common inflammatory dermatosis worldwide, often resulting in sequelae such as scarring, PIE, and PIH,” presenting author Jamie Hu, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study results were presented during an abstract session. “This dyschromia can cause greater psychological distress than the original acne lesions, and disproportionately affects skin of color patients.”
Blemish-prone skin is known to have higher levels of sebum and lower levels of antioxidants, leading to lipid peroxidation and oxidative stress, resulting in proliferation of Cutibacterium acnes and an inflammatory cascade that has recently been implicated in postinflammatory dyschromia and the development of PIE and PIH, noted Dr. Hu, a dermatology resident at the University of Miami. “Therefore, the use of antioxidants presents an opportunity to disrupt blemish and dyschromia,” she said.
One such antioxidant is silymarin, which is derived from the milk thistle plant. Recent studies have demonstrated that silymarin reduces proinflammatory mediators, prevents lipid peroxidation, and presents a new way to target the treatment of both acne and postinflammatory dyschromia.
Dr. Hu’s mentor, Jill S. Waibel, MD, owner and medical director of the Miami Dermatology and Laser Institute, hypothesized that nonablative laser therapy followed by topical application of silymarin would improve acne-associated postinflammatory dyschromia. To test her hunch, she conducted a 12-week, prospective trial in which 24 patients with PIE and/or PIH were randomized to one of two treatment arms: laser treatment with topical antioxidants or laser treatment with vehicle control. Patients received three laser treatments, each 1 month apart. The topical antioxidant used was Silymarin CF, a serum that contains 0.5% silymarin, 0.5% salicylic acid, 15% L-ascorbic acid, and 0.5% ferulic acid. (The study was sponsored by SkinCeuticals, the manufacturer of the serum.)
Laser selection was made primarily on the type of dyschromia, with PIE patients receiving treatment with the pulsed dye laser and PIH patients receiving treatment with the 1,927-nm thulium laser. Patients were treated on days 0, 28, and 56 of the 12-week study, followed by immediate application of topical antioxidants or vehicle control. They were also instructed to apply the assigned topical twice daily for the duration of the study. Patients ranged in age from 21 to 61 years, and 20 had skin types III-IV.
To evaluate efficacy, the researchers conducted blinded clinical assessments with the postacne hyperpigmentation index (PAHPI) and the Global Aesthetic Improvement Scale (GAIS), instrumentation with the Mexameter, a device that captures erythema and melanin index values, and visual diagnostics with optical coherence tomography (OCT).
Dr. Hu reported that at week 12, the PAHPI in the silymarin-plus-laser treatment group fell from an average of 3.18 to 1.74 (a decrease of 1.44), which suggested an improvement trend, compared with the laser treatment–only group, whose PAHPI fell from an average of 3.25 to 1.97 (a decrease of 1.28).
As for the GAIS, a one-time score assessed at the end of the trial, the average score for all patients was 3.24, which translated to “much improved/very much improved.” Patients in the silymarin-plus-laser treatment group had higher average scores compared with patients in the laser treatment–only group (3.35 vs. 3.10, respectively), but the differences did not reach statistical significance.
According to results of the Mexameter assessment, paired t-tests showed that the levels of intralesional melanin decreased significantly for patients in the silymarin-plus-laser treatment group, compared with the laser treatment–only group (P < .05). OCT assessments demonstrated an increase in dermal brightness in both groups, corresponding to an increase in dermal collagen, as well as an increase in blood vessel density.
In an interview at the meeting, Dr. Waibel, subsection chief of dermatology at Baptist Hospital of Miami, said that future studies will focus on long-term follow-up to determine if acne scars can be prevented by combining silymarin with lasers to prevent PIH and PIE. “That would be priceless,” she said. “I believe that the PIH is what causes damage to the collagen, and that damage to the collagen is what causes the scarring. So, if we can prevent or treat PIH, we may be able to prevent scarring.”
This approach, she added, “would decrease the pharmaceutical cost because I think there are many dermatologists who are treating PEI and PIH as active acne. You really have to have a keen eye for understanding the differences and you really have to be looking, because PIE and PIH are flat, whereas active acne consists of either comedones or nodules.”
She noted that in skin of color patients, she has seen PIH persist for 9 or 10 months after treatment with isotretinoin. “It’s not the isotretinoin causing the scars, or even the acne, it’s the prolonged inflammation,” she said.
Catherine M. DiGiorgio, MD, a Boston-based laser and cosmetic dermatologist who was asked to comment on the study, said that patients and dermatologists frequently seek alternatives to hydroquinone for unwanted hyperpigmentation.
“This topical contains an active ingredient – silymarin – obtained from the milk thistle plant along with several already well known topicals used for the treatment of acne and PIH,” said Dr. DiGiorgio, program co-chair of the 2023 ASLMS conference. “Further and larger studies are needed to demonstrate and support the effectiveness of this product and silymarin for PIH and/or PIE.”
Also commenting on the results, Ray Jalian, MD, a Los Angeles–based laser and cosmetic dermatologist, told this news organization that the study findings demonstrate the power of combining topical and laser treatment for more effective improvement in acne-related PIH.
“While the study failed to show statistically significant improvement in postinflammatory erythema with concomitant laser and topical therapy versus laser alone, the promising data supporting concurrent use of topicals and fractional lasers for treatment of PIH, particularly in dark skin phototypes, is a clinically impactful contribution to our daily practice,” he said.
Dr. Waibel disclosed that she has conducted clinical trials for many device and pharmaceutical companies including SkinCeuticals. Dr. Hu, Dr. DiGiorgio, and Dr. Jalian were not involved with the study and reported having no relevant disclosures.
AT ASLMS 2023
Branding tattoo removal helps sex trafficking survivor close door on painful past
PHOENIX – When Kathy Givens walked onstage during a plenary session at the annual conference of the American Society for Laser Medicine and Surgery to reflect on her 9-month ordeal being sex trafficked in Texas more than 20 years ago, you could hear a pin drop.
“One of the scariest things about the life of sex trafficking is not knowing who’s going to be on the other side,” said Ms. Givens, who now lives in Houston. “There was some violence. There were some horrible things that happened. But you know what was really scary? When I got out. People may ask, ‘How’s that so? You escaped your trafficker. The past is behind you. Why were you afraid?’ I was afraid because I didn’t know that I had community. I didn’t know that community or that society would care about someone like me.”
She said that she found herself immobilized by fear of being shamed in society and labeled a sex trafficking victim, and wondered if she could overcome that fear and if anyone would view her as human again. Once free from her trafficker, she began a “healing journey,” which included getting married, raising four children, and re-enrolling in college with hopes of becoming a social worker. In 2020, she and her husband founded Twelve 11 Partners, an organization committed to supporting human trafficking survivors.
“I was working in the anti-trafficking field helping other survivors ... who have experienced this horrific crime,” she said. “I thought I was on my way.” But one “stain” from her sex trafficking past remained: The name of her trafficker was tattooed on her skin, “a reminder of what I’d gone through.”
Ms. Givens was eventually introduced to Paul M. Friedman, MD, the current ASLMS president and one of the that was formed in 2022. According to a survey that Dr. Friedman and colleagues presented at the 2022 annual ASLMS conference, an estimated 1 in 2 sex trafficking survivors have branding tattoos, and at least 1,000 survivors a year could benefit from removal of those tattoos.
“To date, 87 physicians in the U.S. and one in Canada have stepped forward to volunteer their services to be part of this program,” Dr. Friedman, who directs the Dermatology and Laser Surgery Center in Houston, said at this year’s meeting. “My goal is to double this number by the next annual conference,” he added, noting that trauma-informed training is part of the program, “to support the survivor experience during the treatment process.”
ASLMS is also working on this issue in partnership with the American Academy of Dermatology (AAD) Ad Hoc Task Force on Dermatological Resources for the Intervention and Prevention of Human Trafficking, which is headed by Boston dermatologist Shadi Kourosh, MD.
“Dermatologists are uniquely positioned to aid in efforts to assist those experiences in trafficking with our training to recognize and diagnose relevant signs on the skin and to assist patients with certain aspects of care and recovery including the treatment of the disease of scars and tattoos,” Dr. Friedman said. “Ultimately, we hope to create a database together to improve recognition of branding tattoos to aid in identifying sex trafficking victims.”
Ms. Givens, who sits on the U.S. Advisory Council on Human Trafficking, said that she was able to truly close the door on her sex trafficking past thanks to the tattoo removal Dr. Friedman performed as part of New Beginnings. “It means the world to me to know that I can now be an advocate for other individuals who have experienced human trafficking,” she told meeting attendees.
“Again, one of the scariest things is not knowing that you have community. I was scared of losing hope, but I’m standing here today. I have all the hope that I need. You have the power to change lives.”
PHOENIX – When Kathy Givens walked onstage during a plenary session at the annual conference of the American Society for Laser Medicine and Surgery to reflect on her 9-month ordeal being sex trafficked in Texas more than 20 years ago, you could hear a pin drop.
“One of the scariest things about the life of sex trafficking is not knowing who’s going to be on the other side,” said Ms. Givens, who now lives in Houston. “There was some violence. There were some horrible things that happened. But you know what was really scary? When I got out. People may ask, ‘How’s that so? You escaped your trafficker. The past is behind you. Why were you afraid?’ I was afraid because I didn’t know that I had community. I didn’t know that community or that society would care about someone like me.”
She said that she found herself immobilized by fear of being shamed in society and labeled a sex trafficking victim, and wondered if she could overcome that fear and if anyone would view her as human again. Once free from her trafficker, she began a “healing journey,” which included getting married, raising four children, and re-enrolling in college with hopes of becoming a social worker. In 2020, she and her husband founded Twelve 11 Partners, an organization committed to supporting human trafficking survivors.
“I was working in the anti-trafficking field helping other survivors ... who have experienced this horrific crime,” she said. “I thought I was on my way.” But one “stain” from her sex trafficking past remained: The name of her trafficker was tattooed on her skin, “a reminder of what I’d gone through.”
Ms. Givens was eventually introduced to Paul M. Friedman, MD, the current ASLMS president and one of the that was formed in 2022. According to a survey that Dr. Friedman and colleagues presented at the 2022 annual ASLMS conference, an estimated 1 in 2 sex trafficking survivors have branding tattoos, and at least 1,000 survivors a year could benefit from removal of those tattoos.
“To date, 87 physicians in the U.S. and one in Canada have stepped forward to volunteer their services to be part of this program,” Dr. Friedman, who directs the Dermatology and Laser Surgery Center in Houston, said at this year’s meeting. “My goal is to double this number by the next annual conference,” he added, noting that trauma-informed training is part of the program, “to support the survivor experience during the treatment process.”
ASLMS is also working on this issue in partnership with the American Academy of Dermatology (AAD) Ad Hoc Task Force on Dermatological Resources for the Intervention and Prevention of Human Trafficking, which is headed by Boston dermatologist Shadi Kourosh, MD.
“Dermatologists are uniquely positioned to aid in efforts to assist those experiences in trafficking with our training to recognize and diagnose relevant signs on the skin and to assist patients with certain aspects of care and recovery including the treatment of the disease of scars and tattoos,” Dr. Friedman said. “Ultimately, we hope to create a database together to improve recognition of branding tattoos to aid in identifying sex trafficking victims.”
Ms. Givens, who sits on the U.S. Advisory Council on Human Trafficking, said that she was able to truly close the door on her sex trafficking past thanks to the tattoo removal Dr. Friedman performed as part of New Beginnings. “It means the world to me to know that I can now be an advocate for other individuals who have experienced human trafficking,” she told meeting attendees.
“Again, one of the scariest things is not knowing that you have community. I was scared of losing hope, but I’m standing here today. I have all the hope that I need. You have the power to change lives.”
PHOENIX – When Kathy Givens walked onstage during a plenary session at the annual conference of the American Society for Laser Medicine and Surgery to reflect on her 9-month ordeal being sex trafficked in Texas more than 20 years ago, you could hear a pin drop.
“One of the scariest things about the life of sex trafficking is not knowing who’s going to be on the other side,” said Ms. Givens, who now lives in Houston. “There was some violence. There were some horrible things that happened. But you know what was really scary? When I got out. People may ask, ‘How’s that so? You escaped your trafficker. The past is behind you. Why were you afraid?’ I was afraid because I didn’t know that I had community. I didn’t know that community or that society would care about someone like me.”
She said that she found herself immobilized by fear of being shamed in society and labeled a sex trafficking victim, and wondered if she could overcome that fear and if anyone would view her as human again. Once free from her trafficker, she began a “healing journey,” which included getting married, raising four children, and re-enrolling in college with hopes of becoming a social worker. In 2020, she and her husband founded Twelve 11 Partners, an organization committed to supporting human trafficking survivors.
“I was working in the anti-trafficking field helping other survivors ... who have experienced this horrific crime,” she said. “I thought I was on my way.” But one “stain” from her sex trafficking past remained: The name of her trafficker was tattooed on her skin, “a reminder of what I’d gone through.”
Ms. Givens was eventually introduced to Paul M. Friedman, MD, the current ASLMS president and one of the that was formed in 2022. According to a survey that Dr. Friedman and colleagues presented at the 2022 annual ASLMS conference, an estimated 1 in 2 sex trafficking survivors have branding tattoos, and at least 1,000 survivors a year could benefit from removal of those tattoos.
“To date, 87 physicians in the U.S. and one in Canada have stepped forward to volunteer their services to be part of this program,” Dr. Friedman, who directs the Dermatology and Laser Surgery Center in Houston, said at this year’s meeting. “My goal is to double this number by the next annual conference,” he added, noting that trauma-informed training is part of the program, “to support the survivor experience during the treatment process.”
ASLMS is also working on this issue in partnership with the American Academy of Dermatology (AAD) Ad Hoc Task Force on Dermatological Resources for the Intervention and Prevention of Human Trafficking, which is headed by Boston dermatologist Shadi Kourosh, MD.
“Dermatologists are uniquely positioned to aid in efforts to assist those experiences in trafficking with our training to recognize and diagnose relevant signs on the skin and to assist patients with certain aspects of care and recovery including the treatment of the disease of scars and tattoos,” Dr. Friedman said. “Ultimately, we hope to create a database together to improve recognition of branding tattoos to aid in identifying sex trafficking victims.”
Ms. Givens, who sits on the U.S. Advisory Council on Human Trafficking, said that she was able to truly close the door on her sex trafficking past thanks to the tattoo removal Dr. Friedman performed as part of New Beginnings. “It means the world to me to know that I can now be an advocate for other individuals who have experienced human trafficking,” she told meeting attendees.
“Again, one of the scariest things is not knowing that you have community. I was scared of losing hope, but I’m standing here today. I have all the hope that I need. You have the power to change lives.”
AT ASLMS 2023
Small study finds IPL-radiofrequency combination effective for dry eye disease
PHOENIX – and improved meibum quality in both upper and lower eyelids, results from an ongoing, novel study showed.
Dry eye disease affects a large proportion of people in the United States “and the factors that contribute to that are certainly not going away,” lead study author James G. Chelnis MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where he presented the results during an abstract session. “Prepandemic, we used to have meetings in person; now most are on a computer screen,” a common risk factor for worsening dry eyes, he said. Telltale dry eye symptoms include blurry vision, irritation, and corneal damage – mostly caused by meibomian gland dysfunction – which impacts the quality and quantity of meibum secreted. Common treatments include warm compresses, doxycycline, and artificial tears.
While some studies have shown IPL is helpful in treating dry eye disease caused by meibomian gland dysfunction, little information is available on its use alone or in combination with topical RF to preserve and improve the function of meibomian glands, said Dr. Chelnis, an ophthalmic plastic surgeon in New York City. “The theory here is that the radiofrequency would be able to vibrate the water molecules inside the meibomian glands, which would allow you to turn over the meibum faster, as well as improve the blink reflex response by building supporting collagen,” he said. “Our novel study explores the ability of this combined modality treatment to improve upon meibomian gland health.”
Study design, results
Dr. Chelnis and his colleagues enrolled 11 individuals with a previous diagnosis of dry eye disease and meibomian gland dysfunction with Ocular Surface Disease Index (OSDI) survey scores higher than 23, which indicate at least moderate dry eye symptoms. Inclusion criteria were being 22 years of age or older, signs of meibomian gland dysfunction as detected by biomicroscopy, a modified meibomian gland score over 12 in the lower eyelid of at least one eye, and type I-IV skin.
All patients received four treatments (each 2 weeks apart) of IPL to the lower eyelid, surrounding malar region, and nose, followed by 7 minutes of topical RF treatments at 1 MHz and 4 MHz extending to the inferior, lateral, and superior orbital rim. Evaluation of meibomian gland expression and quality of meibum upon expression was conducted following each treatment session, with a final evaluation 4 weeks after the final treatment session.
Meibum quality was evaluated on a scale of 0-3 representing clear (0), cloudy (1), inspissated (2), and blocked (3) meibum, respectively.
Following treatment, meibomian gland expression and meibum quality improved in all eyelids in all 11 patients. Specifically, in the right eye, the number of upper lid expressible glands increased from an average of 13 to 27.9 and the number of lower lid expressible glands increased from an average of 14.6 to 28.2; and in the left eye, the number of upper lid expressible glands increased from an average of 13.3 to 27.3 and the number of lower lid expressible glands increased from an average of 14.8 to 26.8 (P < .001 for all associations).
The overall percentage improvement in meibomian gland expression in the right eye was 82.7% for the upper lids and 136.6% for the lower lids, and in the left eye, 82.9% for the upper lids, and 112.2% for the lower lids.
When comparing upper against lower lids, meibomian gland expression increased 124.4% and 82.8%, respectively. Meibum quality improved in all four eyelids, although upper eyelids displayed a superior improvement compared with lower eyelids.
“We are finding that combining IPL plus RF produces a more complete and comprehensive improvement in the quality of their meibomian gland health, and as such, their dry eyes,” with “a large decrease in their symptom profile,” he concluded.
More patients to be studied
Dr. Chelnis acknowledged certain limitations of the study, including the small number of patients, but he and his colleagues have added an additional clinical site to expand the sample size. “Larger scale studies are needed to evaluate long-term effectiveness of IPL plus RF as well as a comparison with other treatment options.”
During a question-and-answer session Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, who served as one of the abstract session moderators, asked Dr. Chelnis to comment on what the mechanism of action of the IPL-RF combination in improving meibomian gland health.
“It’s not fully understood, but part of it is improved vascularity at the lid margin,” said Dr. Chelnis, who holds a faculty position in the department of ophthalmology at Icahn School of Medicine at Mount Sinai, New York. “Your ocular surface is sort of like your screen door; it catches everything that’s in the environment. An increase in vascularity and immunologic cytokines occurs in response to that. If you’re looking at the eye with a slit lamp, you can see a lot of vascularity that occurs at the lid margin and crowds the meibomian glands. When you decrease that crowding and immunogenic response, you move towards a normally functioning lid margin.”
Dr. Chelnis disclosed that he is a consultant to or an adviser for Lumenis, Horizon Therapeutics, and Soniquence.
PHOENIX – and improved meibum quality in both upper and lower eyelids, results from an ongoing, novel study showed.
Dry eye disease affects a large proportion of people in the United States “and the factors that contribute to that are certainly not going away,” lead study author James G. Chelnis MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where he presented the results during an abstract session. “Prepandemic, we used to have meetings in person; now most are on a computer screen,” a common risk factor for worsening dry eyes, he said. Telltale dry eye symptoms include blurry vision, irritation, and corneal damage – mostly caused by meibomian gland dysfunction – which impacts the quality and quantity of meibum secreted. Common treatments include warm compresses, doxycycline, and artificial tears.
While some studies have shown IPL is helpful in treating dry eye disease caused by meibomian gland dysfunction, little information is available on its use alone or in combination with topical RF to preserve and improve the function of meibomian glands, said Dr. Chelnis, an ophthalmic plastic surgeon in New York City. “The theory here is that the radiofrequency would be able to vibrate the water molecules inside the meibomian glands, which would allow you to turn over the meibum faster, as well as improve the blink reflex response by building supporting collagen,” he said. “Our novel study explores the ability of this combined modality treatment to improve upon meibomian gland health.”
Study design, results
Dr. Chelnis and his colleagues enrolled 11 individuals with a previous diagnosis of dry eye disease and meibomian gland dysfunction with Ocular Surface Disease Index (OSDI) survey scores higher than 23, which indicate at least moderate dry eye symptoms. Inclusion criteria were being 22 years of age or older, signs of meibomian gland dysfunction as detected by biomicroscopy, a modified meibomian gland score over 12 in the lower eyelid of at least one eye, and type I-IV skin.
All patients received four treatments (each 2 weeks apart) of IPL to the lower eyelid, surrounding malar region, and nose, followed by 7 minutes of topical RF treatments at 1 MHz and 4 MHz extending to the inferior, lateral, and superior orbital rim. Evaluation of meibomian gland expression and quality of meibum upon expression was conducted following each treatment session, with a final evaluation 4 weeks after the final treatment session.
Meibum quality was evaluated on a scale of 0-3 representing clear (0), cloudy (1), inspissated (2), and blocked (3) meibum, respectively.
Following treatment, meibomian gland expression and meibum quality improved in all eyelids in all 11 patients. Specifically, in the right eye, the number of upper lid expressible glands increased from an average of 13 to 27.9 and the number of lower lid expressible glands increased from an average of 14.6 to 28.2; and in the left eye, the number of upper lid expressible glands increased from an average of 13.3 to 27.3 and the number of lower lid expressible glands increased from an average of 14.8 to 26.8 (P < .001 for all associations).
The overall percentage improvement in meibomian gland expression in the right eye was 82.7% for the upper lids and 136.6% for the lower lids, and in the left eye, 82.9% for the upper lids, and 112.2% for the lower lids.
When comparing upper against lower lids, meibomian gland expression increased 124.4% and 82.8%, respectively. Meibum quality improved in all four eyelids, although upper eyelids displayed a superior improvement compared with lower eyelids.
“We are finding that combining IPL plus RF produces a more complete and comprehensive improvement in the quality of their meibomian gland health, and as such, their dry eyes,” with “a large decrease in their symptom profile,” he concluded.
More patients to be studied
Dr. Chelnis acknowledged certain limitations of the study, including the small number of patients, but he and his colleagues have added an additional clinical site to expand the sample size. “Larger scale studies are needed to evaluate long-term effectiveness of IPL plus RF as well as a comparison with other treatment options.”
During a question-and-answer session Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, who served as one of the abstract session moderators, asked Dr. Chelnis to comment on what the mechanism of action of the IPL-RF combination in improving meibomian gland health.
“It’s not fully understood, but part of it is improved vascularity at the lid margin,” said Dr. Chelnis, who holds a faculty position in the department of ophthalmology at Icahn School of Medicine at Mount Sinai, New York. “Your ocular surface is sort of like your screen door; it catches everything that’s in the environment. An increase in vascularity and immunologic cytokines occurs in response to that. If you’re looking at the eye with a slit lamp, you can see a lot of vascularity that occurs at the lid margin and crowds the meibomian glands. When you decrease that crowding and immunogenic response, you move towards a normally functioning lid margin.”
Dr. Chelnis disclosed that he is a consultant to or an adviser for Lumenis, Horizon Therapeutics, and Soniquence.
PHOENIX – and improved meibum quality in both upper and lower eyelids, results from an ongoing, novel study showed.
Dry eye disease affects a large proportion of people in the United States “and the factors that contribute to that are certainly not going away,” lead study author James G. Chelnis MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where he presented the results during an abstract session. “Prepandemic, we used to have meetings in person; now most are on a computer screen,” a common risk factor for worsening dry eyes, he said. Telltale dry eye symptoms include blurry vision, irritation, and corneal damage – mostly caused by meibomian gland dysfunction – which impacts the quality and quantity of meibum secreted. Common treatments include warm compresses, doxycycline, and artificial tears.
While some studies have shown IPL is helpful in treating dry eye disease caused by meibomian gland dysfunction, little information is available on its use alone or in combination with topical RF to preserve and improve the function of meibomian glands, said Dr. Chelnis, an ophthalmic plastic surgeon in New York City. “The theory here is that the radiofrequency would be able to vibrate the water molecules inside the meibomian glands, which would allow you to turn over the meibum faster, as well as improve the blink reflex response by building supporting collagen,” he said. “Our novel study explores the ability of this combined modality treatment to improve upon meibomian gland health.”
Study design, results
Dr. Chelnis and his colleagues enrolled 11 individuals with a previous diagnosis of dry eye disease and meibomian gland dysfunction with Ocular Surface Disease Index (OSDI) survey scores higher than 23, which indicate at least moderate dry eye symptoms. Inclusion criteria were being 22 years of age or older, signs of meibomian gland dysfunction as detected by biomicroscopy, a modified meibomian gland score over 12 in the lower eyelid of at least one eye, and type I-IV skin.
All patients received four treatments (each 2 weeks apart) of IPL to the lower eyelid, surrounding malar region, and nose, followed by 7 minutes of topical RF treatments at 1 MHz and 4 MHz extending to the inferior, lateral, and superior orbital rim. Evaluation of meibomian gland expression and quality of meibum upon expression was conducted following each treatment session, with a final evaluation 4 weeks after the final treatment session.
Meibum quality was evaluated on a scale of 0-3 representing clear (0), cloudy (1), inspissated (2), and blocked (3) meibum, respectively.
Following treatment, meibomian gland expression and meibum quality improved in all eyelids in all 11 patients. Specifically, in the right eye, the number of upper lid expressible glands increased from an average of 13 to 27.9 and the number of lower lid expressible glands increased from an average of 14.6 to 28.2; and in the left eye, the number of upper lid expressible glands increased from an average of 13.3 to 27.3 and the number of lower lid expressible glands increased from an average of 14.8 to 26.8 (P < .001 for all associations).
The overall percentage improvement in meibomian gland expression in the right eye was 82.7% for the upper lids and 136.6% for the lower lids, and in the left eye, 82.9% for the upper lids, and 112.2% for the lower lids.
When comparing upper against lower lids, meibomian gland expression increased 124.4% and 82.8%, respectively. Meibum quality improved in all four eyelids, although upper eyelids displayed a superior improvement compared with lower eyelids.
“We are finding that combining IPL plus RF produces a more complete and comprehensive improvement in the quality of their meibomian gland health, and as such, their dry eyes,” with “a large decrease in their symptom profile,” he concluded.
More patients to be studied
Dr. Chelnis acknowledged certain limitations of the study, including the small number of patients, but he and his colleagues have added an additional clinical site to expand the sample size. “Larger scale studies are needed to evaluate long-term effectiveness of IPL plus RF as well as a comparison with other treatment options.”
During a question-and-answer session Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, who served as one of the abstract session moderators, asked Dr. Chelnis to comment on what the mechanism of action of the IPL-RF combination in improving meibomian gland health.
“It’s not fully understood, but part of it is improved vascularity at the lid margin,” said Dr. Chelnis, who holds a faculty position in the department of ophthalmology at Icahn School of Medicine at Mount Sinai, New York. “Your ocular surface is sort of like your screen door; it catches everything that’s in the environment. An increase in vascularity and immunologic cytokines occurs in response to that. If you’re looking at the eye with a slit lamp, you can see a lot of vascularity that occurs at the lid margin and crowds the meibomian glands. When you decrease that crowding and immunogenic response, you move towards a normally functioning lid margin.”
Dr. Chelnis disclosed that he is a consultant to or an adviser for Lumenis, Horizon Therapeutics, and Soniquence.
AT ASLMS 2023
What are the main reasons patients sue dermatologists?
PHOENIX – , and the defendants were more likely to be male.
Those are among key findings from a study that aimed to determine the reasons patients pursue litigation against dermatologists.
“The number of lawsuits against physicians continues to climb annually,” Young Lim, MD, PhD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the results were presented during an abstract session. “Depending on the study, anywhere between 75 to 99 percent of physicians will face a lawsuit by age 65. A clear understanding of prior litigations will help mitigate similar errors in future practice and promote safer, higher quality care.”
Dr. Lim, a dermatology resident at Massachusetts General Hospital and Harvard Medical School, Boston, along with Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, and H. Ray Jalian, MD, a cosmetic dermatologist who practices in Los Angeles, used two large national database repositories, WestlawNext and LexisNexis, to retrospectively analyze legal documents following a query using “dermatology” and “dermatologist” as search terms to capture all variety of litigations. They excluded cases in which litigation did not involve patient care as well as those in which the dermatologist was the plaintiff and those in which the dermatologist was involved as a third party.
The final analysis consisted of 54 claims, comprising 43 state and 11 federal cases. Of the 54 cases, 35 involved a male defendant, 12 involved a female defendant, and 7 cases either did not specify the gender of the defendant or involved multiple defendants. Of the 35 cases involving a male defendant, 23 (66%) were brought by female plaintiffs.
Most cases (49, or 91%) involved a defendant dermatologist in private practice while the remaining 5 involved a defendant dermatologist in an academic setting.
The most common reason for litigation was accidental injury (27 cases, or 50%), followed by incorrect or delayed diagnoses (22 cases, or 41%). Five cases resulted from the dermatologist failing to communicate important information, such as postop care instructions or obtaining informed consent.
Of all 54 cases 30 (56%) were dismissed prior to trial, while 24 (44%) resulted in a judgment for the plaintiff. According to Dr. Lim, payout information was available for only five cases, and ranged from $15,000 (injury from laser) to $1,950,000 (delayed diagnosis of malignant melanoma).
“While lawsuits from patients against dermatologists largely involve injury from elective procedures, clinicians should practice caution regarding missed or delayed diagnoses when practicing medical dermatology,” the authors concluded in their abstract. “Ensuring that critical information is shared with patients and obtaining proper written consent will also safeguard against easily-avoidable litigations.”
Christopher B. Zachary, MBBS, professor and chair emeritus of the department of dermatology at the University of California, Irvine, who was asked to comment on the study, said that the findings are a reminder that lack of attention to the most simply performed aspects of care can be the reasons patients will seek medical malpractice redress.
“Consent requires careful and thoughtful explanation of a planned procedure, which should then be recorded in the chart to avoid future confusion,” Dr. Zachary told this news organization. “A patient’s signature on a consent form obtained by a staff member is clearly inadequate if not accompanied by a clear and understandable preoperative discussion. Words, images, video are all elements that aid patients’ comprehension of a planned procedure. And postoperative instructions given to the patients while on the laser table are commonly forgotten by the patient and must be accompanied by written advice summary. Patients will frequently misremember instructions and can be overwhelmed by medical jargon.”
Neither the researchers nor Dr. Zachary reported having relevant financial disclosures.
PHOENIX – , and the defendants were more likely to be male.
Those are among key findings from a study that aimed to determine the reasons patients pursue litigation against dermatologists.
“The number of lawsuits against physicians continues to climb annually,” Young Lim, MD, PhD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the results were presented during an abstract session. “Depending on the study, anywhere between 75 to 99 percent of physicians will face a lawsuit by age 65. A clear understanding of prior litigations will help mitigate similar errors in future practice and promote safer, higher quality care.”
Dr. Lim, a dermatology resident at Massachusetts General Hospital and Harvard Medical School, Boston, along with Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, and H. Ray Jalian, MD, a cosmetic dermatologist who practices in Los Angeles, used two large national database repositories, WestlawNext and LexisNexis, to retrospectively analyze legal documents following a query using “dermatology” and “dermatologist” as search terms to capture all variety of litigations. They excluded cases in which litigation did not involve patient care as well as those in which the dermatologist was the plaintiff and those in which the dermatologist was involved as a third party.
The final analysis consisted of 54 claims, comprising 43 state and 11 federal cases. Of the 54 cases, 35 involved a male defendant, 12 involved a female defendant, and 7 cases either did not specify the gender of the defendant or involved multiple defendants. Of the 35 cases involving a male defendant, 23 (66%) were brought by female plaintiffs.
Most cases (49, or 91%) involved a defendant dermatologist in private practice while the remaining 5 involved a defendant dermatologist in an academic setting.
The most common reason for litigation was accidental injury (27 cases, or 50%), followed by incorrect or delayed diagnoses (22 cases, or 41%). Five cases resulted from the dermatologist failing to communicate important information, such as postop care instructions or obtaining informed consent.
Of all 54 cases 30 (56%) were dismissed prior to trial, while 24 (44%) resulted in a judgment for the plaintiff. According to Dr. Lim, payout information was available for only five cases, and ranged from $15,000 (injury from laser) to $1,950,000 (delayed diagnosis of malignant melanoma).
“While lawsuits from patients against dermatologists largely involve injury from elective procedures, clinicians should practice caution regarding missed or delayed diagnoses when practicing medical dermatology,” the authors concluded in their abstract. “Ensuring that critical information is shared with patients and obtaining proper written consent will also safeguard against easily-avoidable litigations.”
Christopher B. Zachary, MBBS, professor and chair emeritus of the department of dermatology at the University of California, Irvine, who was asked to comment on the study, said that the findings are a reminder that lack of attention to the most simply performed aspects of care can be the reasons patients will seek medical malpractice redress.
“Consent requires careful and thoughtful explanation of a planned procedure, which should then be recorded in the chart to avoid future confusion,” Dr. Zachary told this news organization. “A patient’s signature on a consent form obtained by a staff member is clearly inadequate if not accompanied by a clear and understandable preoperative discussion. Words, images, video are all elements that aid patients’ comprehension of a planned procedure. And postoperative instructions given to the patients while on the laser table are commonly forgotten by the patient and must be accompanied by written advice summary. Patients will frequently misremember instructions and can be overwhelmed by medical jargon.”
Neither the researchers nor Dr. Zachary reported having relevant financial disclosures.
PHOENIX – , and the defendants were more likely to be male.
Those are among key findings from a study that aimed to determine the reasons patients pursue litigation against dermatologists.
“The number of lawsuits against physicians continues to climb annually,” Young Lim, MD, PhD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the results were presented during an abstract session. “Depending on the study, anywhere between 75 to 99 percent of physicians will face a lawsuit by age 65. A clear understanding of prior litigations will help mitigate similar errors in future practice and promote safer, higher quality care.”
Dr. Lim, a dermatology resident at Massachusetts General Hospital and Harvard Medical School, Boston, along with Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, and H. Ray Jalian, MD, a cosmetic dermatologist who practices in Los Angeles, used two large national database repositories, WestlawNext and LexisNexis, to retrospectively analyze legal documents following a query using “dermatology” and “dermatologist” as search terms to capture all variety of litigations. They excluded cases in which litigation did not involve patient care as well as those in which the dermatologist was the plaintiff and those in which the dermatologist was involved as a third party.
The final analysis consisted of 54 claims, comprising 43 state and 11 federal cases. Of the 54 cases, 35 involved a male defendant, 12 involved a female defendant, and 7 cases either did not specify the gender of the defendant or involved multiple defendants. Of the 35 cases involving a male defendant, 23 (66%) were brought by female plaintiffs.
Most cases (49, or 91%) involved a defendant dermatologist in private practice while the remaining 5 involved a defendant dermatologist in an academic setting.
The most common reason for litigation was accidental injury (27 cases, or 50%), followed by incorrect or delayed diagnoses (22 cases, or 41%). Five cases resulted from the dermatologist failing to communicate important information, such as postop care instructions or obtaining informed consent.
Of all 54 cases 30 (56%) were dismissed prior to trial, while 24 (44%) resulted in a judgment for the plaintiff. According to Dr. Lim, payout information was available for only five cases, and ranged from $15,000 (injury from laser) to $1,950,000 (delayed diagnosis of malignant melanoma).
“While lawsuits from patients against dermatologists largely involve injury from elective procedures, clinicians should practice caution regarding missed or delayed diagnoses when practicing medical dermatology,” the authors concluded in their abstract. “Ensuring that critical information is shared with patients and obtaining proper written consent will also safeguard against easily-avoidable litigations.”
Christopher B. Zachary, MBBS, professor and chair emeritus of the department of dermatology at the University of California, Irvine, who was asked to comment on the study, said that the findings are a reminder that lack of attention to the most simply performed aspects of care can be the reasons patients will seek medical malpractice redress.
“Consent requires careful and thoughtful explanation of a planned procedure, which should then be recorded in the chart to avoid future confusion,” Dr. Zachary told this news organization. “A patient’s signature on a consent form obtained by a staff member is clearly inadequate if not accompanied by a clear and understandable preoperative discussion. Words, images, video are all elements that aid patients’ comprehension of a planned procedure. And postoperative instructions given to the patients while on the laser table are commonly forgotten by the patient and must be accompanied by written advice summary. Patients will frequently misremember instructions and can be overwhelmed by medical jargon.”
Neither the researchers nor Dr. Zachary reported having relevant financial disclosures.
AT ASLMS 2023
Ten-year analysis finds relatively low complication rate from fractional resurfacing lasers
PHOENIX – over a decade showed.
To investigate, Dr. Hashemi, a third-year dermatology resident at Harvard University and Massachusetts General Hospital, Boston, and Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, drew from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which compiles medical device reports for suspected injuries from device use or malfunction and represents the largest repository of device adverse effects. Medical device reports are submitted by manufacturers, clinicians, patients, and others.
The researchers limited their query to MDRs related to ablative and nonablative fractional resurfacing lasers over the 10-year period from 2013 to 2022. The query was performed in January 2023 using a comprehensive list of product names and manufacturers.
The initial search yielded 240 MDRs, which were individually reviewed for duplicate records or insufficient data, and the final analysis included 165 MDRs. The 10 most reported adverse events were burns (30%), followed by dyspigmentation (14%), scarring (12%), other (11%), postoperative infection (8%), blisters (6%), pain (5%), hypertrophic scar (4%), post-treatment inflammation (4%), and textural changes (3%). Within the 10-year period analyzed, 56% of MDRs occurred between 2016 and 2019, with a disproportionately low percentage of MDRs occurring in 2022 (5%).
“Adverse events due to ablative and nonablative fractional resurfacing lasers are rare but potentially serious,” Dr. Hashemi concluded. “Care must be taken with counseling, patient selection, and treatment settings to optimize safety, informed consent, and patient satisfaction. Given the relatively low number of adverse events seen with fractional resurfacing lasers, factors driving their safety should be further explored.”
He added that he was surprised by the relatively low number of reported issues, referring to the total of 165 cases over 10 years. By comparison, he said, body contouring had 660 cases reported over a 7-year period in one recent study.
According to the MAUDE website, submitting MDRs to MAUDE is mandatory for manufacturers, importers, and device user facilities, and are voluntary for other groups, such as health care professionals, patients, and consumers.
Dr. Hashemi disclosed that he is a consultant for Castle Biosciences. He is also an entrepreneur in residence for Gore Range Capital.
PHOENIX – over a decade showed.
To investigate, Dr. Hashemi, a third-year dermatology resident at Harvard University and Massachusetts General Hospital, Boston, and Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, drew from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which compiles medical device reports for suspected injuries from device use or malfunction and represents the largest repository of device adverse effects. Medical device reports are submitted by manufacturers, clinicians, patients, and others.
The researchers limited their query to MDRs related to ablative and nonablative fractional resurfacing lasers over the 10-year period from 2013 to 2022. The query was performed in January 2023 using a comprehensive list of product names and manufacturers.
The initial search yielded 240 MDRs, which were individually reviewed for duplicate records or insufficient data, and the final analysis included 165 MDRs. The 10 most reported adverse events were burns (30%), followed by dyspigmentation (14%), scarring (12%), other (11%), postoperative infection (8%), blisters (6%), pain (5%), hypertrophic scar (4%), post-treatment inflammation (4%), and textural changes (3%). Within the 10-year period analyzed, 56% of MDRs occurred between 2016 and 2019, with a disproportionately low percentage of MDRs occurring in 2022 (5%).
“Adverse events due to ablative and nonablative fractional resurfacing lasers are rare but potentially serious,” Dr. Hashemi concluded. “Care must be taken with counseling, patient selection, and treatment settings to optimize safety, informed consent, and patient satisfaction. Given the relatively low number of adverse events seen with fractional resurfacing lasers, factors driving their safety should be further explored.”
He added that he was surprised by the relatively low number of reported issues, referring to the total of 165 cases over 10 years. By comparison, he said, body contouring had 660 cases reported over a 7-year period in one recent study.
According to the MAUDE website, submitting MDRs to MAUDE is mandatory for manufacturers, importers, and device user facilities, and are voluntary for other groups, such as health care professionals, patients, and consumers.
Dr. Hashemi disclosed that he is a consultant for Castle Biosciences. He is also an entrepreneur in residence for Gore Range Capital.
PHOENIX – over a decade showed.
To investigate, Dr. Hashemi, a third-year dermatology resident at Harvard University and Massachusetts General Hospital, Boston, and Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, drew from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which compiles medical device reports for suspected injuries from device use or malfunction and represents the largest repository of device adverse effects. Medical device reports are submitted by manufacturers, clinicians, patients, and others.
The researchers limited their query to MDRs related to ablative and nonablative fractional resurfacing lasers over the 10-year period from 2013 to 2022. The query was performed in January 2023 using a comprehensive list of product names and manufacturers.
The initial search yielded 240 MDRs, which were individually reviewed for duplicate records or insufficient data, and the final analysis included 165 MDRs. The 10 most reported adverse events were burns (30%), followed by dyspigmentation (14%), scarring (12%), other (11%), postoperative infection (8%), blisters (6%), pain (5%), hypertrophic scar (4%), post-treatment inflammation (4%), and textural changes (3%). Within the 10-year period analyzed, 56% of MDRs occurred between 2016 and 2019, with a disproportionately low percentage of MDRs occurring in 2022 (5%).
“Adverse events due to ablative and nonablative fractional resurfacing lasers are rare but potentially serious,” Dr. Hashemi concluded. “Care must be taken with counseling, patient selection, and treatment settings to optimize safety, informed consent, and patient satisfaction. Given the relatively low number of adverse events seen with fractional resurfacing lasers, factors driving their safety should be further explored.”
He added that he was surprised by the relatively low number of reported issues, referring to the total of 165 cases over 10 years. By comparison, he said, body contouring had 660 cases reported over a 7-year period in one recent study.
According to the MAUDE website, submitting MDRs to MAUDE is mandatory for manufacturers, importers, and device user facilities, and are voluntary for other groups, such as health care professionals, patients, and consumers.
Dr. Hashemi disclosed that he is a consultant for Castle Biosciences. He is also an entrepreneur in residence for Gore Range Capital.
AT ASLMS 2023