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Is it safe to pair low-power fractional diode lasers with cosmetic injectables in a single session?
, results from a 6-year, single-center review showed.
“These treatments can be complementary in single-session treatments and can offer increased convenience for both patients and physicians,” primary study author Jordan V. Wang, MD, MBE, MBA, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.
To date, limited studies have demonstrated the safety of pairing botulinum neurotoxin type A and soft-tissue fillers with laser and other energy-based devices during the same treatment session on the same day, said Dr. Wang, medical research director at the Laser & Skin Surgery Center of New York. “Some concerns remain, though, regarding patient safety and efficacy,” he said. “Data on single-session treatment with low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers and either botulinum neurotoxin or fillers are lacking.”
In a retrospective review of electronic medical records conducted from May 2015 to April 2021, Dr. Wang, Roy G. Geronemus, MD, and Carolyn Kushner, MD evaluated patients who received a single-session facial treatment with either BoNT-A or soft-tissue fillers and the low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers (Clear+Brilliant Perméa and Original, Solta, Pleasanton, Calif.). Safety was assessed by documenting adverse events related to the spread of BoNT-A and fillers or laser treatment of filled areas within 4 weeks.
Adverse events they looked for related to botulinum neurotoxin use included eyelid ptosis; neck weakness or spasms; impairments in chewing, swallowing, speech, and respiration; and prescriptions of apraclonidine eye drops. Filler-related adverse events they looked for included product migration, unexpected loss of filler volume, vascular occlusion, acute pain, necrosis, blindness, and burn. “For both, we looked at hospital or emergency room transfers or admissions and referrals to ENT or ophthalmology,” Dr. Wang said.
During the 6-year study period, 525 patients had 1,562 single-session laser treatments with a mean 46.4 units of BoNT-A, and 398 patients had 1,237 single-session treatments with a mean 1.6 soft-tissue filler syringes. Among those who received BoNT-A, most (93%) were female, their mean age was 51 years, and 99% were treated with a 1,927-nm wavelength at a medium setting in 87% of cases. The top five injection sites were glabella (82%), forehead (69%), periorbital area (64%), neck (40%), and jawline and/or masseters (13%).
The researchers noted one case (0.06%) where apraclonidine eye drops were prescribed for ptosis. The patient had undergone eight other single-session treatments without issue. There were no other documented adverse events directly related to spread of BoNT-A. According to Dr. Wang, this rate of ptosis is lower than the incidence with BoNT-A alone in two landmark trials studying its effects on glabellar lines, which was reported as 5.4% and 1.0%.
Among the 398 patients who received soft-tissue fillers, most (94%) were female, their mean age was 54 years, and 99% were treated with a 1927nm wavelength at a medium setting in 97% of cases. The top five injection sites were cheeks and/or tear troughs (89%), perioral area and/or marionette lines (77%), lips (34%), nasolabial folds (19%), and temples (11%), and the mean number of filler syringes per treatment was 1.6. Slightly more than half (51%) had 1 session, while the remainder had 2 to greater than 10 sessions. The researchers observed no documented adverse events related to spread of fillers or laser treatment of filled areas.
“This laser is a low-powered device that creates small, superficial, and transient microchannels, which likely contributes to the safety of single-session treatments with cosmetic injectables,” Dr. Wang said. However, prospective studies are needed to further validate these results, he added.
“With this very mild laser, it is not surprising that combined treatment had no effect,” said Eric F. Bernstein, MD, MSE, director of the Main Line Center for Laser Surgery in Ardmore, Pa., who was asked to comment on the study results. “There have been numerous anecdotal reports of spreading of botulinum toxin effect to areas not in the target area for treatment following a variety of lasers, including the more powerful version of the laser used in this study. In addition, spread following vascular and other lasers has been reported,” he noted
The laser used in this study, Dr. Bernstein continued, “is low powered and emits a wavelength that is very superficially absorbed, resulting in injury to the stratum corneum, superficial epidermis, or possibly the very superficial dermis, and is often used by physician extenders and not physicians – although I suspect this is not the case in the current study. One can have a reasonable degree of confidence when combining this laser with injectables, but these results cannot be extrapolated to other devices.”
The abstract received the annual ASDS Carruthers Award during the meeting. Dr. Wang reported that he is a consultant or advisor to Allergan, Alastin, AVAVA, Cynosure, Lutronic, Novoxel, Sofwave, and Solta. Dr. Bernstein reported having received research funding from Cynosure, Candela, and Acclaro. He also has received consulting fees from Cynosure and holds ownership interest in Candela, Novoxel, OnSite, Joylux, and Acclaro and has served on the advisory board for Novoxel, Cynosure, and Acclaro.
, results from a 6-year, single-center review showed.
“These treatments can be complementary in single-session treatments and can offer increased convenience for both patients and physicians,” primary study author Jordan V. Wang, MD, MBE, MBA, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.
To date, limited studies have demonstrated the safety of pairing botulinum neurotoxin type A and soft-tissue fillers with laser and other energy-based devices during the same treatment session on the same day, said Dr. Wang, medical research director at the Laser & Skin Surgery Center of New York. “Some concerns remain, though, regarding patient safety and efficacy,” he said. “Data on single-session treatment with low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers and either botulinum neurotoxin or fillers are lacking.”
In a retrospective review of electronic medical records conducted from May 2015 to April 2021, Dr. Wang, Roy G. Geronemus, MD, and Carolyn Kushner, MD evaluated patients who received a single-session facial treatment with either BoNT-A or soft-tissue fillers and the low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers (Clear+Brilliant Perméa and Original, Solta, Pleasanton, Calif.). Safety was assessed by documenting adverse events related to the spread of BoNT-A and fillers or laser treatment of filled areas within 4 weeks.
Adverse events they looked for related to botulinum neurotoxin use included eyelid ptosis; neck weakness or spasms; impairments in chewing, swallowing, speech, and respiration; and prescriptions of apraclonidine eye drops. Filler-related adverse events they looked for included product migration, unexpected loss of filler volume, vascular occlusion, acute pain, necrosis, blindness, and burn. “For both, we looked at hospital or emergency room transfers or admissions and referrals to ENT or ophthalmology,” Dr. Wang said.
During the 6-year study period, 525 patients had 1,562 single-session laser treatments with a mean 46.4 units of BoNT-A, and 398 patients had 1,237 single-session treatments with a mean 1.6 soft-tissue filler syringes. Among those who received BoNT-A, most (93%) were female, their mean age was 51 years, and 99% were treated with a 1,927-nm wavelength at a medium setting in 87% of cases. The top five injection sites were glabella (82%), forehead (69%), periorbital area (64%), neck (40%), and jawline and/or masseters (13%).
The researchers noted one case (0.06%) where apraclonidine eye drops were prescribed for ptosis. The patient had undergone eight other single-session treatments without issue. There were no other documented adverse events directly related to spread of BoNT-A. According to Dr. Wang, this rate of ptosis is lower than the incidence with BoNT-A alone in two landmark trials studying its effects on glabellar lines, which was reported as 5.4% and 1.0%.
Among the 398 patients who received soft-tissue fillers, most (94%) were female, their mean age was 54 years, and 99% were treated with a 1927nm wavelength at a medium setting in 97% of cases. The top five injection sites were cheeks and/or tear troughs (89%), perioral area and/or marionette lines (77%), lips (34%), nasolabial folds (19%), and temples (11%), and the mean number of filler syringes per treatment was 1.6. Slightly more than half (51%) had 1 session, while the remainder had 2 to greater than 10 sessions. The researchers observed no documented adverse events related to spread of fillers or laser treatment of filled areas.
“This laser is a low-powered device that creates small, superficial, and transient microchannels, which likely contributes to the safety of single-session treatments with cosmetic injectables,” Dr. Wang said. However, prospective studies are needed to further validate these results, he added.
“With this very mild laser, it is not surprising that combined treatment had no effect,” said Eric F. Bernstein, MD, MSE, director of the Main Line Center for Laser Surgery in Ardmore, Pa., who was asked to comment on the study results. “There have been numerous anecdotal reports of spreading of botulinum toxin effect to areas not in the target area for treatment following a variety of lasers, including the more powerful version of the laser used in this study. In addition, spread following vascular and other lasers has been reported,” he noted
The laser used in this study, Dr. Bernstein continued, “is low powered and emits a wavelength that is very superficially absorbed, resulting in injury to the stratum corneum, superficial epidermis, or possibly the very superficial dermis, and is often used by physician extenders and not physicians – although I suspect this is not the case in the current study. One can have a reasonable degree of confidence when combining this laser with injectables, but these results cannot be extrapolated to other devices.”
The abstract received the annual ASDS Carruthers Award during the meeting. Dr. Wang reported that he is a consultant or advisor to Allergan, Alastin, AVAVA, Cynosure, Lutronic, Novoxel, Sofwave, and Solta. Dr. Bernstein reported having received research funding from Cynosure, Candela, and Acclaro. He also has received consulting fees from Cynosure and holds ownership interest in Candela, Novoxel, OnSite, Joylux, and Acclaro and has served on the advisory board for Novoxel, Cynosure, and Acclaro.
, results from a 6-year, single-center review showed.
“These treatments can be complementary in single-session treatments and can offer increased convenience for both patients and physicians,” primary study author Jordan V. Wang, MD, MBE, MBA, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.
To date, limited studies have demonstrated the safety of pairing botulinum neurotoxin type A and soft-tissue fillers with laser and other energy-based devices during the same treatment session on the same day, said Dr. Wang, medical research director at the Laser & Skin Surgery Center of New York. “Some concerns remain, though, regarding patient safety and efficacy,” he said. “Data on single-session treatment with low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers and either botulinum neurotoxin or fillers are lacking.”
In a retrospective review of electronic medical records conducted from May 2015 to April 2021, Dr. Wang, Roy G. Geronemus, MD, and Carolyn Kushner, MD evaluated patients who received a single-session facial treatment with either BoNT-A or soft-tissue fillers and the low-power, low-density 1,927-nm and 1,440-nm fractional diode lasers (Clear+Brilliant Perméa and Original, Solta, Pleasanton, Calif.). Safety was assessed by documenting adverse events related to the spread of BoNT-A and fillers or laser treatment of filled areas within 4 weeks.
Adverse events they looked for related to botulinum neurotoxin use included eyelid ptosis; neck weakness or spasms; impairments in chewing, swallowing, speech, and respiration; and prescriptions of apraclonidine eye drops. Filler-related adverse events they looked for included product migration, unexpected loss of filler volume, vascular occlusion, acute pain, necrosis, blindness, and burn. “For both, we looked at hospital or emergency room transfers or admissions and referrals to ENT or ophthalmology,” Dr. Wang said.
During the 6-year study period, 525 patients had 1,562 single-session laser treatments with a mean 46.4 units of BoNT-A, and 398 patients had 1,237 single-session treatments with a mean 1.6 soft-tissue filler syringes. Among those who received BoNT-A, most (93%) were female, their mean age was 51 years, and 99% were treated with a 1,927-nm wavelength at a medium setting in 87% of cases. The top five injection sites were glabella (82%), forehead (69%), periorbital area (64%), neck (40%), and jawline and/or masseters (13%).
The researchers noted one case (0.06%) where apraclonidine eye drops were prescribed for ptosis. The patient had undergone eight other single-session treatments without issue. There were no other documented adverse events directly related to spread of BoNT-A. According to Dr. Wang, this rate of ptosis is lower than the incidence with BoNT-A alone in two landmark trials studying its effects on glabellar lines, which was reported as 5.4% and 1.0%.
Among the 398 patients who received soft-tissue fillers, most (94%) were female, their mean age was 54 years, and 99% were treated with a 1927nm wavelength at a medium setting in 97% of cases. The top five injection sites were cheeks and/or tear troughs (89%), perioral area and/or marionette lines (77%), lips (34%), nasolabial folds (19%), and temples (11%), and the mean number of filler syringes per treatment was 1.6. Slightly more than half (51%) had 1 session, while the remainder had 2 to greater than 10 sessions. The researchers observed no documented adverse events related to spread of fillers or laser treatment of filled areas.
“This laser is a low-powered device that creates small, superficial, and transient microchannels, which likely contributes to the safety of single-session treatments with cosmetic injectables,” Dr. Wang said. However, prospective studies are needed to further validate these results, he added.
“With this very mild laser, it is not surprising that combined treatment had no effect,” said Eric F. Bernstein, MD, MSE, director of the Main Line Center for Laser Surgery in Ardmore, Pa., who was asked to comment on the study results. “There have been numerous anecdotal reports of spreading of botulinum toxin effect to areas not in the target area for treatment following a variety of lasers, including the more powerful version of the laser used in this study. In addition, spread following vascular and other lasers has been reported,” he noted
The laser used in this study, Dr. Bernstein continued, “is low powered and emits a wavelength that is very superficially absorbed, resulting in injury to the stratum corneum, superficial epidermis, or possibly the very superficial dermis, and is often used by physician extenders and not physicians – although I suspect this is not the case in the current study. One can have a reasonable degree of confidence when combining this laser with injectables, but these results cannot be extrapolated to other devices.”
The abstract received the annual ASDS Carruthers Award during the meeting. Dr. Wang reported that he is a consultant or advisor to Allergan, Alastin, AVAVA, Cynosure, Lutronic, Novoxel, Sofwave, and Solta. Dr. Bernstein reported having received research funding from Cynosure, Candela, and Acclaro. He also has received consulting fees from Cynosure and holds ownership interest in Candela, Novoxel, OnSite, Joylux, and Acclaro and has served on the advisory board for Novoxel, Cynosure, and Acclaro.
FROM ASDS 2021
Dermatologists driving use of vascular lasers in the Medicare population
In addition, as a proportion of Medicare charges submitted that were reimbursed, the highest reimbursements were for dermatologists and those in the Western geographic region.
Those are among the key findings from an analysis that aimed to characterize trends in use and reimbursement patterns of vascular lasers in the Medicare-insured population.
“There are several modalities for vascular laser treatment, including the pulse dye laser, the frequency doubled KTP laser, and others,” presenting author Partik Singh, MD, MBA, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “Laser treatment of vascular lesions may sometimes be covered by insurance, depending on the indication, but little is known about how and which clinicians are taking advantage of this covered treatment.”
Dr. Singh, a 2nd-year dermatology resident at the University of Rochester Medical Center, and coauthor Mara Weinstein Velez, MD, extracted data from the 2012-2018 Medicare Public Use File, which includes 100% fee-for-service, non–Medicare Advantage claims based on CPT codes, yet no information on patient data, clinical context, or indications. Outcomes of interest were total vascular laser claims per year, annual vascular laser claims per clinician, annual clinicians using vascular lasers, accepted reimbursements defined by the allowed charge or the submitted charge to Medicare, and clinical specialties and geographic location.
The researchers found that more than half of clinicians who used vascular lasers during the study period were dermatologists (55%), followed by general surgeons (6%), family practice/internal medicine physicians (5% each) and various others. Use of vascular lasers among all clinicians increased 10.5% annually during the study period, from 3,786 to 6,883, and was most pronounced among dermatologists, whose use increased 18.4% annually, from 1,878 to 5,182. “Nondermatologists did not have a big change in their overall utilization rate, but they did have a steady utilization of vascular lasers, roughly at almost 2,000 claims per year,” Dr. Singh said.
The researchers also observed that the use of vascular lasers on a per-clinician basis increased 7.4% annually among all clinicians during the study period, from 77.3 to 118.7. This was mostly driven by dermatologists, whose per-clinician use increased 10.4% annually, from 81.7 to 148.7. Use by nondermatologists remained about stable, with just a 0.1% increase annually, from 73.4 to 74. In addition, the number of clinicians who billed for vascular laser procedures increased 2.9% annually between 2012 and 2018, from 49 to 58. This growth was driven mostly by dermatologists, who increased their billing for vascular laser procedures by 7.2% annually, from 23 to 35 clinicians.
In other findings, dermatologists were reimbursed at 68.3% of submitted charges, compared with 59.3% of charges submitted by other clinicians (P = .0001), and reimbursement rates were greatest in the Western geographic region of the United States vs. the Northeast, Midwest, and Southern regions (73.1% vs. 50.2%, 65.4%, and 55.3%, respectively; P < .0001).
“Use of vascular lasers is increasing primarily among dermatologists, though there is steady use of these procedures by nondermatologists,” Dr. Singh concluded. “Medicare charges were more often fully reimbursed when billed by dermatologists and those in the Western U.S., perhaps suggesting a better familiarity with appropriate indications and better administrative resources for coverage of vascular laser procedures.”
After the meeting, Dr. Singh acknowledged certain limitations of the analysis, including the fact that it “was limited only to Medicare Part B fee-for-service claims, not including Medicare Advantage,” he told this news organization. “Our conclusions do not necessarily hold true for Medicaid or commercial insurers, for instance. Moreover, this dataset doesn’t provide patient-specific information, such as the indication for the procedure. Further studies are needed to characterize utilization of various lasers in not only Medicare beneficiaries, but also those with Medicaid, private insurance, and patients paying out-of-pocket. Additionally, study is also needed to explain why these differences in reimbursement hold true.”
The researchers reported having no relevant financial disclosures.
In addition, as a proportion of Medicare charges submitted that were reimbursed, the highest reimbursements were for dermatologists and those in the Western geographic region.
Those are among the key findings from an analysis that aimed to characterize trends in use and reimbursement patterns of vascular lasers in the Medicare-insured population.
“There are several modalities for vascular laser treatment, including the pulse dye laser, the frequency doubled KTP laser, and others,” presenting author Partik Singh, MD, MBA, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “Laser treatment of vascular lesions may sometimes be covered by insurance, depending on the indication, but little is known about how and which clinicians are taking advantage of this covered treatment.”
Dr. Singh, a 2nd-year dermatology resident at the University of Rochester Medical Center, and coauthor Mara Weinstein Velez, MD, extracted data from the 2012-2018 Medicare Public Use File, which includes 100% fee-for-service, non–Medicare Advantage claims based on CPT codes, yet no information on patient data, clinical context, or indications. Outcomes of interest were total vascular laser claims per year, annual vascular laser claims per clinician, annual clinicians using vascular lasers, accepted reimbursements defined by the allowed charge or the submitted charge to Medicare, and clinical specialties and geographic location.
The researchers found that more than half of clinicians who used vascular lasers during the study period were dermatologists (55%), followed by general surgeons (6%), family practice/internal medicine physicians (5% each) and various others. Use of vascular lasers among all clinicians increased 10.5% annually during the study period, from 3,786 to 6,883, and was most pronounced among dermatologists, whose use increased 18.4% annually, from 1,878 to 5,182. “Nondermatologists did not have a big change in their overall utilization rate, but they did have a steady utilization of vascular lasers, roughly at almost 2,000 claims per year,” Dr. Singh said.
The researchers also observed that the use of vascular lasers on a per-clinician basis increased 7.4% annually among all clinicians during the study period, from 77.3 to 118.7. This was mostly driven by dermatologists, whose per-clinician use increased 10.4% annually, from 81.7 to 148.7. Use by nondermatologists remained about stable, with just a 0.1% increase annually, from 73.4 to 74. In addition, the number of clinicians who billed for vascular laser procedures increased 2.9% annually between 2012 and 2018, from 49 to 58. This growth was driven mostly by dermatologists, who increased their billing for vascular laser procedures by 7.2% annually, from 23 to 35 clinicians.
In other findings, dermatologists were reimbursed at 68.3% of submitted charges, compared with 59.3% of charges submitted by other clinicians (P = .0001), and reimbursement rates were greatest in the Western geographic region of the United States vs. the Northeast, Midwest, and Southern regions (73.1% vs. 50.2%, 65.4%, and 55.3%, respectively; P < .0001).
“Use of vascular lasers is increasing primarily among dermatologists, though there is steady use of these procedures by nondermatologists,” Dr. Singh concluded. “Medicare charges were more often fully reimbursed when billed by dermatologists and those in the Western U.S., perhaps suggesting a better familiarity with appropriate indications and better administrative resources for coverage of vascular laser procedures.”
After the meeting, Dr. Singh acknowledged certain limitations of the analysis, including the fact that it “was limited only to Medicare Part B fee-for-service claims, not including Medicare Advantage,” he told this news organization. “Our conclusions do not necessarily hold true for Medicaid or commercial insurers, for instance. Moreover, this dataset doesn’t provide patient-specific information, such as the indication for the procedure. Further studies are needed to characterize utilization of various lasers in not only Medicare beneficiaries, but also those with Medicaid, private insurance, and patients paying out-of-pocket. Additionally, study is also needed to explain why these differences in reimbursement hold true.”
The researchers reported having no relevant financial disclosures.
In addition, as a proportion of Medicare charges submitted that were reimbursed, the highest reimbursements were for dermatologists and those in the Western geographic region.
Those are among the key findings from an analysis that aimed to characterize trends in use and reimbursement patterns of vascular lasers in the Medicare-insured population.
“There are several modalities for vascular laser treatment, including the pulse dye laser, the frequency doubled KTP laser, and others,” presenting author Partik Singh, MD, MBA, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “Laser treatment of vascular lesions may sometimes be covered by insurance, depending on the indication, but little is known about how and which clinicians are taking advantage of this covered treatment.”
Dr. Singh, a 2nd-year dermatology resident at the University of Rochester Medical Center, and coauthor Mara Weinstein Velez, MD, extracted data from the 2012-2018 Medicare Public Use File, which includes 100% fee-for-service, non–Medicare Advantage claims based on CPT codes, yet no information on patient data, clinical context, or indications. Outcomes of interest were total vascular laser claims per year, annual vascular laser claims per clinician, annual clinicians using vascular lasers, accepted reimbursements defined by the allowed charge or the submitted charge to Medicare, and clinical specialties and geographic location.
The researchers found that more than half of clinicians who used vascular lasers during the study period were dermatologists (55%), followed by general surgeons (6%), family practice/internal medicine physicians (5% each) and various others. Use of vascular lasers among all clinicians increased 10.5% annually during the study period, from 3,786 to 6,883, and was most pronounced among dermatologists, whose use increased 18.4% annually, from 1,878 to 5,182. “Nondermatologists did not have a big change in their overall utilization rate, but they did have a steady utilization of vascular lasers, roughly at almost 2,000 claims per year,” Dr. Singh said.
The researchers also observed that the use of vascular lasers on a per-clinician basis increased 7.4% annually among all clinicians during the study period, from 77.3 to 118.7. This was mostly driven by dermatologists, whose per-clinician use increased 10.4% annually, from 81.7 to 148.7. Use by nondermatologists remained about stable, with just a 0.1% increase annually, from 73.4 to 74. In addition, the number of clinicians who billed for vascular laser procedures increased 2.9% annually between 2012 and 2018, from 49 to 58. This growth was driven mostly by dermatologists, who increased their billing for vascular laser procedures by 7.2% annually, from 23 to 35 clinicians.
In other findings, dermatologists were reimbursed at 68.3% of submitted charges, compared with 59.3% of charges submitted by other clinicians (P = .0001), and reimbursement rates were greatest in the Western geographic region of the United States vs. the Northeast, Midwest, and Southern regions (73.1% vs. 50.2%, 65.4%, and 55.3%, respectively; P < .0001).
“Use of vascular lasers is increasing primarily among dermatologists, though there is steady use of these procedures by nondermatologists,” Dr. Singh concluded. “Medicare charges were more often fully reimbursed when billed by dermatologists and those in the Western U.S., perhaps suggesting a better familiarity with appropriate indications and better administrative resources for coverage of vascular laser procedures.”
After the meeting, Dr. Singh acknowledged certain limitations of the analysis, including the fact that it “was limited only to Medicare Part B fee-for-service claims, not including Medicare Advantage,” he told this news organization. “Our conclusions do not necessarily hold true for Medicaid or commercial insurers, for instance. Moreover, this dataset doesn’t provide patient-specific information, such as the indication for the procedure. Further studies are needed to characterize utilization of various lasers in not only Medicare beneficiaries, but also those with Medicaid, private insurance, and patients paying out-of-pocket. Additionally, study is also needed to explain why these differences in reimbursement hold true.”
The researchers reported having no relevant financial disclosures.
FROM ASDS 2021
Elevated mortality seen in Merkel cell patients from rural areas
This paradox was discovered in an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) Program that primary author Bryan T. Carroll, MD, PhD, and colleagues presented during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.
“MCC is a rare and aggressive neoplasm of the skin with high mortality,” said coauthor Emma Larson, MD, a dermatology clinical research fellow at University Hospitals of Cleveland. “Previous studies have demonstrated that MCC survival is lower in low–dermatologist density areas. Associations are difficult to characterize without historical staging data aggregated from large registries. We hypothesized that decreased MCC survival is associated with rural counties.”
The researchers used 18 registries from the November 2019 SEER database to retrospectively evaluate adults who were diagnosed with MCC between 2004 and 2015 as confirmed by positive histology. Study endpoints were SEER historic stage at diagnosis and 5-year survival. MCC cases were stratified by 2013 USDA urban-rural continuum codes, which defines metropolitan counties as those with a population of 1 million or more, urban counties as those with a population of less than 1 million, and rural counties as nonmetropolitan counties not adjacent to a metropolitan area.
A total of 6,291 cases with a mean age of 75 years were included in the final analysis: 3,750 from metro areas, 2,235 from urban areas, and 306 from rural areas. A higher proportion of MCC patients from rural areas were male (69% vs. 62% from metro areas and 64% from urban areas) and white (97% vs. 95% and 96%, respectively). “This may contribute to differences in MCC care,” Dr. Larson said. “However, we also found that there is an increased incidence of locally staged disease in rural areas (51%) than in metro (44%) or urban (45%) areas (P = .02). In addition, fewer lymph node surgeries were performed in rural (50%) and urban (51%) areas than in metro areas (45%; P = .01).”
Overall survival was worse among patients in rural areas (a mean of 34 months), compared with those in urban (a mean of 41 months) and metro areas (a mean of 47 months; P = .02). “This may be due to the fact that rural counties have the higher risk factors for MCC incidence and death, but when we account for the confounders, including sex, age, race, and MCC stage, we still found a difference in overall survival in rural counties, compared to metro and urban counties,” Dr. Larson said.
Dr. Carroll, an associate professor of dermatology at University Hospitals of Cleveland, characterized the finding as “not what you’d expect with a higher incidence of local disease. Therefore, there is the potential for mis-staging in rural counties, where we did see that the interrogation of lymph nodes was done less frequently than in urban centers, which were more aligned with National Comprehensive Cancer Network guidelines during this time period. Still, after correction, rural location is still associated with a higher MCC mortality. There is a need for us to further interrogate what the causes are for this disparity in care between rural and urban centers.”
The other study authors were Dustin DeMeo and Christian Scheufele, MD. The researchers reported having no relevant financial disclosures.
This paradox was discovered in an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) Program that primary author Bryan T. Carroll, MD, PhD, and colleagues presented during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.
“MCC is a rare and aggressive neoplasm of the skin with high mortality,” said coauthor Emma Larson, MD, a dermatology clinical research fellow at University Hospitals of Cleveland. “Previous studies have demonstrated that MCC survival is lower in low–dermatologist density areas. Associations are difficult to characterize without historical staging data aggregated from large registries. We hypothesized that decreased MCC survival is associated with rural counties.”
The researchers used 18 registries from the November 2019 SEER database to retrospectively evaluate adults who were diagnosed with MCC between 2004 and 2015 as confirmed by positive histology. Study endpoints were SEER historic stage at diagnosis and 5-year survival. MCC cases were stratified by 2013 USDA urban-rural continuum codes, which defines metropolitan counties as those with a population of 1 million or more, urban counties as those with a population of less than 1 million, and rural counties as nonmetropolitan counties not adjacent to a metropolitan area.
A total of 6,291 cases with a mean age of 75 years were included in the final analysis: 3,750 from metro areas, 2,235 from urban areas, and 306 from rural areas. A higher proportion of MCC patients from rural areas were male (69% vs. 62% from metro areas and 64% from urban areas) and white (97% vs. 95% and 96%, respectively). “This may contribute to differences in MCC care,” Dr. Larson said. “However, we also found that there is an increased incidence of locally staged disease in rural areas (51%) than in metro (44%) or urban (45%) areas (P = .02). In addition, fewer lymph node surgeries were performed in rural (50%) and urban (51%) areas than in metro areas (45%; P = .01).”
Overall survival was worse among patients in rural areas (a mean of 34 months), compared with those in urban (a mean of 41 months) and metro areas (a mean of 47 months; P = .02). “This may be due to the fact that rural counties have the higher risk factors for MCC incidence and death, but when we account for the confounders, including sex, age, race, and MCC stage, we still found a difference in overall survival in rural counties, compared to metro and urban counties,” Dr. Larson said.
Dr. Carroll, an associate professor of dermatology at University Hospitals of Cleveland, characterized the finding as “not what you’d expect with a higher incidence of local disease. Therefore, there is the potential for mis-staging in rural counties, where we did see that the interrogation of lymph nodes was done less frequently than in urban centers, which were more aligned with National Comprehensive Cancer Network guidelines during this time period. Still, after correction, rural location is still associated with a higher MCC mortality. There is a need for us to further interrogate what the causes are for this disparity in care between rural and urban centers.”
The other study authors were Dustin DeMeo and Christian Scheufele, MD. The researchers reported having no relevant financial disclosures.
This paradox was discovered in an analysis of data from the Surveillance, Epidemiology, and End Results (SEER) Program that primary author Bryan T. Carroll, MD, PhD, and colleagues presented during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery.
“MCC is a rare and aggressive neoplasm of the skin with high mortality,” said coauthor Emma Larson, MD, a dermatology clinical research fellow at University Hospitals of Cleveland. “Previous studies have demonstrated that MCC survival is lower in low–dermatologist density areas. Associations are difficult to characterize without historical staging data aggregated from large registries. We hypothesized that decreased MCC survival is associated with rural counties.”
The researchers used 18 registries from the November 2019 SEER database to retrospectively evaluate adults who were diagnosed with MCC between 2004 and 2015 as confirmed by positive histology. Study endpoints were SEER historic stage at diagnosis and 5-year survival. MCC cases were stratified by 2013 USDA urban-rural continuum codes, which defines metropolitan counties as those with a population of 1 million or more, urban counties as those with a population of less than 1 million, and rural counties as nonmetropolitan counties not adjacent to a metropolitan area.
A total of 6,291 cases with a mean age of 75 years were included in the final analysis: 3,750 from metro areas, 2,235 from urban areas, and 306 from rural areas. A higher proportion of MCC patients from rural areas were male (69% vs. 62% from metro areas and 64% from urban areas) and white (97% vs. 95% and 96%, respectively). “This may contribute to differences in MCC care,” Dr. Larson said. “However, we also found that there is an increased incidence of locally staged disease in rural areas (51%) than in metro (44%) or urban (45%) areas (P = .02). In addition, fewer lymph node surgeries were performed in rural (50%) and urban (51%) areas than in metro areas (45%; P = .01).”
Overall survival was worse among patients in rural areas (a mean of 34 months), compared with those in urban (a mean of 41 months) and metro areas (a mean of 47 months; P = .02). “This may be due to the fact that rural counties have the higher risk factors for MCC incidence and death, but when we account for the confounders, including sex, age, race, and MCC stage, we still found a difference in overall survival in rural counties, compared to metro and urban counties,” Dr. Larson said.
Dr. Carroll, an associate professor of dermatology at University Hospitals of Cleveland, characterized the finding as “not what you’d expect with a higher incidence of local disease. Therefore, there is the potential for mis-staging in rural counties, where we did see that the interrogation of lymph nodes was done less frequently than in urban centers, which were more aligned with National Comprehensive Cancer Network guidelines during this time period. Still, after correction, rural location is still associated with a higher MCC mortality. There is a need for us to further interrogate what the causes are for this disparity in care between rural and urban centers.”
The other study authors were Dustin DeMeo and Christian Scheufele, MD. The researchers reported having no relevant financial disclosures.
FROM ASDS 2021
Filler complications involving vascular necrosis, vision changes on the rise
analysis showed.
“The ASDS estimates that 1.6 million soft tissue filler procedures were performed in 2019, a 78% increase from 2012,” presenting author Michelle Xiong, a 4th-year student at Brown University, Providence, R.I., said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “The popularity of dermal fillers continues to increase. With that, there is increasing concern of possible associated adverse events. Most concerning are those related to vascular occlusion.”
Under the supervision of senior author Kachiu C. Lee, MD, MPH, of Main Line Center for Laser Surgery in Ardmore, Pa., Ms. Xiong and colleagues analyzed the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database of medical device–related adverse event reports, to better understand and characterize dermal filler-related complications. They limited the analysis to adverse events involving injectable fillers from January 2014 to December 2020 and determined the number of complications by type per year and reviewed reports to identify injection site locations. Next, they used the binomial test to compare the proportion of complication categories from 2014 through 2016 and from 2017 through 2020.
In all, 5,994 reports were identified during the 7-year study period. To evaluate trends over time, the researchers estimated the rate of complications per 100 reports each year. While the absolute number of reports increased over time, the rate of adverse events per 100 reports decreased, suggesting an overall improvement in safety.
When the researchers focused on complications involving vascular occlusion, they found that vascular necrosis accounted for 3.5% of all complications, compared with vision changes (1.5% of all complications), and stroke (0.3% of all complications). When comparing the years 2014-2016 with 2017-2020, there was a significant increase in adverse events involving vascular necrosis (0.9%; P = .018) and vision changes (0.94%; P = .001), but no significant difference in the number of reports of stroke (-0.1%; P = .409). “This highlights that serious complications like necrosis and vision changes have increased over time,” Ms. Xiong said.
Overall, the three most common injection sites involving necrosis and vision changes were the cheek, the nose, and the nasolabial fold. The cheek was the most common site associated with stroke. “These findings are similar to those of previous studies, further emphasizing that the nose, nasolabial fold, and cheek are possibly challenging injection sites,” she said.
“In general, as the face is a highly vascular area with many anastomoses, it’s especially important to be aware of facial anatomy when injecting. In addition to awareness of anatomy, injection techniques can influence vascular complications. Unfortunately, the event narratives in the MAUDE database did not go into detail about the procedural technique.”
Ms. Xiong said that as the popularity of dermal fillers continues to grow, “it’s important for providers to understand the possible adverse events, both to better counsel patients and to improve safety management. The proportion of serious complications such as vascular necrosis and vision changes have increased from 2014 to 2020. This highlights an increased need for training to better understand facial anatomy and to emphasize practice techniques to minimize risk.”
Dr. Lee acknowledged certain limitations of the study, including that “submission of adverse events to the MAUDE database are not verified or standardized,” she told this news organization.
“With the ever-increasing popularity of fillers, it is not surprising that the absolute number of complications is rising, but it is also reassuring to see that the overall ratio of complications per hundred reports is down,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “I would be curious to know what proportion of filler complications are due to non–core practitioners compared to dermatologists and plastic surgeons.”
The researchers reported having no financial disclosures.
Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
analysis showed.
“The ASDS estimates that 1.6 million soft tissue filler procedures were performed in 2019, a 78% increase from 2012,” presenting author Michelle Xiong, a 4th-year student at Brown University, Providence, R.I., said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “The popularity of dermal fillers continues to increase. With that, there is increasing concern of possible associated adverse events. Most concerning are those related to vascular occlusion.”
Under the supervision of senior author Kachiu C. Lee, MD, MPH, of Main Line Center for Laser Surgery in Ardmore, Pa., Ms. Xiong and colleagues analyzed the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database of medical device–related adverse event reports, to better understand and characterize dermal filler-related complications. They limited the analysis to adverse events involving injectable fillers from January 2014 to December 2020 and determined the number of complications by type per year and reviewed reports to identify injection site locations. Next, they used the binomial test to compare the proportion of complication categories from 2014 through 2016 and from 2017 through 2020.
In all, 5,994 reports were identified during the 7-year study period. To evaluate trends over time, the researchers estimated the rate of complications per 100 reports each year. While the absolute number of reports increased over time, the rate of adverse events per 100 reports decreased, suggesting an overall improvement in safety.
When the researchers focused on complications involving vascular occlusion, they found that vascular necrosis accounted for 3.5% of all complications, compared with vision changes (1.5% of all complications), and stroke (0.3% of all complications). When comparing the years 2014-2016 with 2017-2020, there was a significant increase in adverse events involving vascular necrosis (0.9%; P = .018) and vision changes (0.94%; P = .001), but no significant difference in the number of reports of stroke (-0.1%; P = .409). “This highlights that serious complications like necrosis and vision changes have increased over time,” Ms. Xiong said.
Overall, the three most common injection sites involving necrosis and vision changes were the cheek, the nose, and the nasolabial fold. The cheek was the most common site associated with stroke. “These findings are similar to those of previous studies, further emphasizing that the nose, nasolabial fold, and cheek are possibly challenging injection sites,” she said.
“In general, as the face is a highly vascular area with many anastomoses, it’s especially important to be aware of facial anatomy when injecting. In addition to awareness of anatomy, injection techniques can influence vascular complications. Unfortunately, the event narratives in the MAUDE database did not go into detail about the procedural technique.”
Ms. Xiong said that as the popularity of dermal fillers continues to grow, “it’s important for providers to understand the possible adverse events, both to better counsel patients and to improve safety management. The proportion of serious complications such as vascular necrosis and vision changes have increased from 2014 to 2020. This highlights an increased need for training to better understand facial anatomy and to emphasize practice techniques to minimize risk.”
Dr. Lee acknowledged certain limitations of the study, including that “submission of adverse events to the MAUDE database are not verified or standardized,” she told this news organization.
“With the ever-increasing popularity of fillers, it is not surprising that the absolute number of complications is rising, but it is also reassuring to see that the overall ratio of complications per hundred reports is down,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “I would be curious to know what proportion of filler complications are due to non–core practitioners compared to dermatologists and plastic surgeons.”
The researchers reported having no financial disclosures.
Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
analysis showed.
“The ASDS estimates that 1.6 million soft tissue filler procedures were performed in 2019, a 78% increase from 2012,” presenting author Michelle Xiong, a 4th-year student at Brown University, Providence, R.I., said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “The popularity of dermal fillers continues to increase. With that, there is increasing concern of possible associated adverse events. Most concerning are those related to vascular occlusion.”
Under the supervision of senior author Kachiu C. Lee, MD, MPH, of Main Line Center for Laser Surgery in Ardmore, Pa., Ms. Xiong and colleagues analyzed the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database of medical device–related adverse event reports, to better understand and characterize dermal filler-related complications. They limited the analysis to adverse events involving injectable fillers from January 2014 to December 2020 and determined the number of complications by type per year and reviewed reports to identify injection site locations. Next, they used the binomial test to compare the proportion of complication categories from 2014 through 2016 and from 2017 through 2020.
In all, 5,994 reports were identified during the 7-year study period. To evaluate trends over time, the researchers estimated the rate of complications per 100 reports each year. While the absolute number of reports increased over time, the rate of adverse events per 100 reports decreased, suggesting an overall improvement in safety.
When the researchers focused on complications involving vascular occlusion, they found that vascular necrosis accounted for 3.5% of all complications, compared with vision changes (1.5% of all complications), and stroke (0.3% of all complications). When comparing the years 2014-2016 with 2017-2020, there was a significant increase in adverse events involving vascular necrosis (0.9%; P = .018) and vision changes (0.94%; P = .001), but no significant difference in the number of reports of stroke (-0.1%; P = .409). “This highlights that serious complications like necrosis and vision changes have increased over time,” Ms. Xiong said.
Overall, the three most common injection sites involving necrosis and vision changes were the cheek, the nose, and the nasolabial fold. The cheek was the most common site associated with stroke. “These findings are similar to those of previous studies, further emphasizing that the nose, nasolabial fold, and cheek are possibly challenging injection sites,” she said.
“In general, as the face is a highly vascular area with many anastomoses, it’s especially important to be aware of facial anatomy when injecting. In addition to awareness of anatomy, injection techniques can influence vascular complications. Unfortunately, the event narratives in the MAUDE database did not go into detail about the procedural technique.”
Ms. Xiong said that as the popularity of dermal fillers continues to grow, “it’s important for providers to understand the possible adverse events, both to better counsel patients and to improve safety management. The proportion of serious complications such as vascular necrosis and vision changes have increased from 2014 to 2020. This highlights an increased need for training to better understand facial anatomy and to emphasize practice techniques to minimize risk.”
Dr. Lee acknowledged certain limitations of the study, including that “submission of adverse events to the MAUDE database are not verified or standardized,” she told this news organization.
“With the ever-increasing popularity of fillers, it is not surprising that the absolute number of complications is rising, but it is also reassuring to see that the overall ratio of complications per hundred reports is down,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “I would be curious to know what proportion of filler complications are due to non–core practitioners compared to dermatologists and plastic surgeons.”
The researchers reported having no financial disclosures.
Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
FROM ASDS 2021
Review finds microneedling an effective add-on to topical melasma therapies
, results from a combined systematic review and meta-analysis suggest.
“Microneedling has a similar efficacy to other drug delivery methods, such as CO2 laser or intradermal microinjections, for the treatment of melasma,” presenting author Marcus G. Tan, MD, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “When used in combination with topical depigmenting therapies, microneedling also demonstrated superior efficacy and a more favorable safety profile compared to oral tranexamic acid.”
For the study, Dr. Tan, a 5-year dermatology resident at the University of Ottawa, and colleagues searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials using the keywords “melasma” and “microneedling.” They limited their analysis to prospective, comparative studies incorporating the use of microneedling in the treatment of melasma and excluded those involving radiofrequency. The primary outcome was improvement in melasma severity, evaluated through the Melasma Area and Severity Index (MASI). The secondary outcomes were improvement in patient satisfaction, quality of life, and any reported adverse events.
Twelve studies involving 459 patients from seven countries were included in the final analysis. Of these, seven were randomized controlled studies and five were nonrandomized split-face studies. Topical treatments used in the studies included tranexamic acid (TXA), vitamin C, platelet-rich plasma, and hydroquinone-based depigmenting serums such as rucinol, sophora-alpha, and N-acetyl glucosamine. Of the 12 studies, 4 used mechanical microneedling and 8 used electric repeating microneedling. The most common needle length used was 1.5 mm, with a range from 0.1 to 1.5 mm, depending on the anatomic site treated. Topical anesthesia was applied 30-60 minutes prior to treatment. Treatment intervals were 2-4 weeks apart.
Their analysis found that microneedling alone resulted in a 23%-29% improvement in MASI. “Across all studies, adding topical therapies resulted in greater improvements in melasma severity, with a moderate effect at 8 weeks and a large effect at 12-16 weeks,” Dr. Tan said. “This also translated to higher patient satisfaction scores and improved patient-reported quality of life.”
A split-face study in the analysis, which compared topical TXA with microneedling to topical TXA with fractional CO2 laser, found that both approaches had similar efficacy and rates of adverse events. Another split-face study that evaluated recalcitrant melasma found that adding vitamin C with microneedling to a nonablative Q-switched Nd:YAG laser resulted in a further 38.3% greater improvement in MASI and a 12.5% lower recurrence rate at 6 months.
In two other studies, researchers compared microneedling to intradermal microinjections to deliver platelet-rich plasma or topical TXA. Both modalities were found to have similar efficacy. “However, microneedling was found to be better tolerated and had higher patient satisfaction as a result,” Dr. Tan said.
A separate analysis found that Tri-Luma (fluocinolone acetonide, hydroquinone, and tretinoin) cream with microneedling outperformed Tri-Luma plus oral TXA in terms of efficacy, patient satisfaction, and tolerability. “Interestingly, adding oral TXA to Tri-Luma with microneedling did not lead to further improvements,” Dr. Tan said.
The researchers found that microneedling was well tolerated in all 12 studies. Overall, no scarring or serious adverse events were reported. Mild-transient dyspigmentation occurred in 5%-12% of cases and herpes simplex virus reactivation was seen in a minority of patients.
Dr. Tan commented on three proposed mechanisms of action, which support the efficacy of microneedling for the treatment of melasma. “First, microneedling assists in the transcutaneous delivery of topical agents through the micropores,” he said. “Second, microneedling also assists in the transcutaneous elimination of melanin and other skin debris through the micropores. Third, the microinjuries stimulate the wound healing response, resulting in neocollagenesis, neoelastogenesis, and epidermal thickening.”
In an interview, Dr. Tan acknowledged certain limitations of the study, including the pooling of randomized and nonrandomized studies in the final meta-analysis, the heterogeneity in the treatment protocols and devices used, as well as the inclusion of studies with a moderate risk of bias. “Nonetheless, these limitations do not affect the conclusion that microneedling is a useful and safe adjuvant to topical therapies for melasma,” he said.
Catherine M. DiGiorgio, MD, who was asked to comment on the study, noted that melasma is a notoriously difficult condition to treat. “Many energy-based device treatments as well as other therapies have been proposed for treatment over the years. However, none have shown reliable, reproducible, and most importantly long-lasting results,” said Dr. DiGiorgio, a laser and cosmetic dermatologist at The Boston Center for Facial Rejuvenation. “Caution should be employed regarding the true efficacy of treatments for other than, at best, temporary results.”
The review included numerous studies without a clear definition of the strengths or methodologies of the studies, she added, noting that randomized controlled split-face studies with long-term follow up are the best way to assess the efficacy of treatments. “Further, regarding drug delivery, microneedling is the least effective method of delivery of drugs to the skin and laser-assisted drug delivery using ablative fractional lasers is the most effective. As with all melasma treatments, healthy skepticism is never a bad approach.”
Dr. Tan reported having no financial disclosures. Dr. DiGiorgio disclosed that she conducts research for Quthero Inc., and holds stock in the company.
, results from a combined systematic review and meta-analysis suggest.
“Microneedling has a similar efficacy to other drug delivery methods, such as CO2 laser or intradermal microinjections, for the treatment of melasma,” presenting author Marcus G. Tan, MD, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “When used in combination with topical depigmenting therapies, microneedling also demonstrated superior efficacy and a more favorable safety profile compared to oral tranexamic acid.”
For the study, Dr. Tan, a 5-year dermatology resident at the University of Ottawa, and colleagues searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials using the keywords “melasma” and “microneedling.” They limited their analysis to prospective, comparative studies incorporating the use of microneedling in the treatment of melasma and excluded those involving radiofrequency. The primary outcome was improvement in melasma severity, evaluated through the Melasma Area and Severity Index (MASI). The secondary outcomes were improvement in patient satisfaction, quality of life, and any reported adverse events.
Twelve studies involving 459 patients from seven countries were included in the final analysis. Of these, seven were randomized controlled studies and five were nonrandomized split-face studies. Topical treatments used in the studies included tranexamic acid (TXA), vitamin C, platelet-rich plasma, and hydroquinone-based depigmenting serums such as rucinol, sophora-alpha, and N-acetyl glucosamine. Of the 12 studies, 4 used mechanical microneedling and 8 used electric repeating microneedling. The most common needle length used was 1.5 mm, with a range from 0.1 to 1.5 mm, depending on the anatomic site treated. Topical anesthesia was applied 30-60 minutes prior to treatment. Treatment intervals were 2-4 weeks apart.
Their analysis found that microneedling alone resulted in a 23%-29% improvement in MASI. “Across all studies, adding topical therapies resulted in greater improvements in melasma severity, with a moderate effect at 8 weeks and a large effect at 12-16 weeks,” Dr. Tan said. “This also translated to higher patient satisfaction scores and improved patient-reported quality of life.”
A split-face study in the analysis, which compared topical TXA with microneedling to topical TXA with fractional CO2 laser, found that both approaches had similar efficacy and rates of adverse events. Another split-face study that evaluated recalcitrant melasma found that adding vitamin C with microneedling to a nonablative Q-switched Nd:YAG laser resulted in a further 38.3% greater improvement in MASI and a 12.5% lower recurrence rate at 6 months.
In two other studies, researchers compared microneedling to intradermal microinjections to deliver platelet-rich plasma or topical TXA. Both modalities were found to have similar efficacy. “However, microneedling was found to be better tolerated and had higher patient satisfaction as a result,” Dr. Tan said.
A separate analysis found that Tri-Luma (fluocinolone acetonide, hydroquinone, and tretinoin) cream with microneedling outperformed Tri-Luma plus oral TXA in terms of efficacy, patient satisfaction, and tolerability. “Interestingly, adding oral TXA to Tri-Luma with microneedling did not lead to further improvements,” Dr. Tan said.
The researchers found that microneedling was well tolerated in all 12 studies. Overall, no scarring or serious adverse events were reported. Mild-transient dyspigmentation occurred in 5%-12% of cases and herpes simplex virus reactivation was seen in a minority of patients.
Dr. Tan commented on three proposed mechanisms of action, which support the efficacy of microneedling for the treatment of melasma. “First, microneedling assists in the transcutaneous delivery of topical agents through the micropores,” he said. “Second, microneedling also assists in the transcutaneous elimination of melanin and other skin debris through the micropores. Third, the microinjuries stimulate the wound healing response, resulting in neocollagenesis, neoelastogenesis, and epidermal thickening.”
In an interview, Dr. Tan acknowledged certain limitations of the study, including the pooling of randomized and nonrandomized studies in the final meta-analysis, the heterogeneity in the treatment protocols and devices used, as well as the inclusion of studies with a moderate risk of bias. “Nonetheless, these limitations do not affect the conclusion that microneedling is a useful and safe adjuvant to topical therapies for melasma,” he said.
Catherine M. DiGiorgio, MD, who was asked to comment on the study, noted that melasma is a notoriously difficult condition to treat. “Many energy-based device treatments as well as other therapies have been proposed for treatment over the years. However, none have shown reliable, reproducible, and most importantly long-lasting results,” said Dr. DiGiorgio, a laser and cosmetic dermatologist at The Boston Center for Facial Rejuvenation. “Caution should be employed regarding the true efficacy of treatments for other than, at best, temporary results.”
The review included numerous studies without a clear definition of the strengths or methodologies of the studies, she added, noting that randomized controlled split-face studies with long-term follow up are the best way to assess the efficacy of treatments. “Further, regarding drug delivery, microneedling is the least effective method of delivery of drugs to the skin and laser-assisted drug delivery using ablative fractional lasers is the most effective. As with all melasma treatments, healthy skepticism is never a bad approach.”
Dr. Tan reported having no financial disclosures. Dr. DiGiorgio disclosed that she conducts research for Quthero Inc., and holds stock in the company.
, results from a combined systematic review and meta-analysis suggest.
“Microneedling has a similar efficacy to other drug delivery methods, such as CO2 laser or intradermal microinjections, for the treatment of melasma,” presenting author Marcus G. Tan, MD, said during a virtual abstract session at the annual meeting of the American Society for Dermatologic Surgery. “When used in combination with topical depigmenting therapies, microneedling also demonstrated superior efficacy and a more favorable safety profile compared to oral tranexamic acid.”
For the study, Dr. Tan, a 5-year dermatology resident at the University of Ottawa, and colleagues searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials using the keywords “melasma” and “microneedling.” They limited their analysis to prospective, comparative studies incorporating the use of microneedling in the treatment of melasma and excluded those involving radiofrequency. The primary outcome was improvement in melasma severity, evaluated through the Melasma Area and Severity Index (MASI). The secondary outcomes were improvement in patient satisfaction, quality of life, and any reported adverse events.
Twelve studies involving 459 patients from seven countries were included in the final analysis. Of these, seven were randomized controlled studies and five were nonrandomized split-face studies. Topical treatments used in the studies included tranexamic acid (TXA), vitamin C, platelet-rich plasma, and hydroquinone-based depigmenting serums such as rucinol, sophora-alpha, and N-acetyl glucosamine. Of the 12 studies, 4 used mechanical microneedling and 8 used electric repeating microneedling. The most common needle length used was 1.5 mm, with a range from 0.1 to 1.5 mm, depending on the anatomic site treated. Topical anesthesia was applied 30-60 minutes prior to treatment. Treatment intervals were 2-4 weeks apart.
Their analysis found that microneedling alone resulted in a 23%-29% improvement in MASI. “Across all studies, adding topical therapies resulted in greater improvements in melasma severity, with a moderate effect at 8 weeks and a large effect at 12-16 weeks,” Dr. Tan said. “This also translated to higher patient satisfaction scores and improved patient-reported quality of life.”
A split-face study in the analysis, which compared topical TXA with microneedling to topical TXA with fractional CO2 laser, found that both approaches had similar efficacy and rates of adverse events. Another split-face study that evaluated recalcitrant melasma found that adding vitamin C with microneedling to a nonablative Q-switched Nd:YAG laser resulted in a further 38.3% greater improvement in MASI and a 12.5% lower recurrence rate at 6 months.
In two other studies, researchers compared microneedling to intradermal microinjections to deliver platelet-rich plasma or topical TXA. Both modalities were found to have similar efficacy. “However, microneedling was found to be better tolerated and had higher patient satisfaction as a result,” Dr. Tan said.
A separate analysis found that Tri-Luma (fluocinolone acetonide, hydroquinone, and tretinoin) cream with microneedling outperformed Tri-Luma plus oral TXA in terms of efficacy, patient satisfaction, and tolerability. “Interestingly, adding oral TXA to Tri-Luma with microneedling did not lead to further improvements,” Dr. Tan said.
The researchers found that microneedling was well tolerated in all 12 studies. Overall, no scarring or serious adverse events were reported. Mild-transient dyspigmentation occurred in 5%-12% of cases and herpes simplex virus reactivation was seen in a minority of patients.
Dr. Tan commented on three proposed mechanisms of action, which support the efficacy of microneedling for the treatment of melasma. “First, microneedling assists in the transcutaneous delivery of topical agents through the micropores,” he said. “Second, microneedling also assists in the transcutaneous elimination of melanin and other skin debris through the micropores. Third, the microinjuries stimulate the wound healing response, resulting in neocollagenesis, neoelastogenesis, and epidermal thickening.”
In an interview, Dr. Tan acknowledged certain limitations of the study, including the pooling of randomized and nonrandomized studies in the final meta-analysis, the heterogeneity in the treatment protocols and devices used, as well as the inclusion of studies with a moderate risk of bias. “Nonetheless, these limitations do not affect the conclusion that microneedling is a useful and safe adjuvant to topical therapies for melasma,” he said.
Catherine M. DiGiorgio, MD, who was asked to comment on the study, noted that melasma is a notoriously difficult condition to treat. “Many energy-based device treatments as well as other therapies have been proposed for treatment over the years. However, none have shown reliable, reproducible, and most importantly long-lasting results,” said Dr. DiGiorgio, a laser and cosmetic dermatologist at The Boston Center for Facial Rejuvenation. “Caution should be employed regarding the true efficacy of treatments for other than, at best, temporary results.”
The review included numerous studies without a clear definition of the strengths or methodologies of the studies, she added, noting that randomized controlled split-face studies with long-term follow up are the best way to assess the efficacy of treatments. “Further, regarding drug delivery, microneedling is the least effective method of delivery of drugs to the skin and laser-assisted drug delivery using ablative fractional lasers is the most effective. As with all melasma treatments, healthy skepticism is never a bad approach.”
Dr. Tan reported having no financial disclosures. Dr. DiGiorgio disclosed that she conducts research for Quthero Inc., and holds stock in the company.
FROM ASDS 2021