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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.
Pilot study: Hybrid laser found effective for treating genitourinary syndrome of menopause
, results from a pilot trial showed.
“The genitourinary syndrome of menopause causes suffering in breast cancer survivors and postmenopausal women,” Jill S. Waibel, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. A common side effect for breast cancer survivors is early onset of menopause that is brought on by treatment, specifically aromatase-inhibitor therapies, she noted.
The symptoms of GSM include discomfort during sex, impaired sexual function, burning or sensation or irritation of the genital area, vaginal constriction, frequent urinary tract infections, urinary incontinence, and vaginal laxity, said Dr. Waibel, owner and medical director of the Miami Dermatology and Laser Institute. Nonhormonal treatments have included OTC vaginal lubricants, OTC moisturizers, low-dose vaginal estrogen – which increases the risk of breast cancer – and systemic estrogen therapy, which also can increase the risk of breast and endometrial cancer. “So, we need a healthy, nondrug option,” she said.
The objective of the pilot study was to determine the safety and efficacy of the diVa hybrid fractional laser as a treatment for symptoms of genitourinary syndrome of menopause, early menopause after breast cancer, or vaginal atrophy. The laser applies tunable nonablative (1,470-nm) and ablative (2,940-nm) wavelengths to the same microscopic treatment zone to maximize results and reduce downtime. The device features a motorized precision guidance system and calibrated rotation for homogeneous pulsing.
“The 2,940-nm wavelength is used to ablate to a depth of 0-800 micrometers while the 1,470-nm wavelength is used to coagulate the epithelium and the lamina propria at a depth of 100-700 micrometers,” said Dr. Waibel, who is also subsection chief of dermatology at Baptist Hospital of Miami. “This combination is used for epithelial tissue to heal quickly and the lamina propria to remodel slowly over time, laying down more collagen in tissue.” Each procedure is delivered via a single-use dilator, which expands the vaginal canal for increased treatment area. “The tip length is 5.5 cm and the diameter is 1 cm,” she said. “The clear tip acts as a hygienic barrier between the tip and the handpiece.”
Study participants included 25 women between the ages of 40 and 70 with early menopause after breast cancer or vaginal atrophy: 20 in the treatment arm and 5 in the sham-treatment arm. Dr. Waibel performed three procedures 2 weeks apart. An ob.gyn. assessed the primary endpoints, which included the Vaginal Health Index Scale (VHIS), the Vaginal Maturation Index (VMI), the Female Sexual Function Index (FSFI) questionnaire, and the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire. Secondary endpoints were histology and a satisfaction questionnaire.
Of the women in the treated group, there were data available for 19 at 3 months follow-up and 17 at 6 months follow-up. Based on the results in these patients, there were statistically significant improvements in nearly all domains of the FSFI treatment arm at 3 and 6 months when compared to baseline, especially arousal (P values of .05 at 3 months and .01 at 6 months) and lubrication (P values of .009 at three months and .001 at 6 months).
Between 3 and 6 months, patients in the treatment arm experienced improvements in four dimensions of the DIVA questionnaire: daily activities (P value of .01 at 3 months to .010 at 6 months), emotional well-being (P value of .06 at 3 months to .014 at 6 months), sexual function (P value of .30 at 3 months to .003 at 6 months), and self-concept/body image (P value of .002 at 3 months to .001 at 6 months).
As for satisfaction, a majority of those in the treatment arm were “somewhat satisfied” with the treatment and would “somewhat likely” repeat and recommend the treatment to friends and family, Dr. Waibel said. Results among the women in the control arm, who were also surveyed, were in the similar range, she noted. (No other results for women in the control arm were available.)
Following treatments, histology revealed that the collagen was denser, fibroblasts were more dense, and vascularity was more notable. No adverse events were observed. “The hybrid fractional laser is safe and effective for treating GSM, early menopause after breast cancer, or vaginal atrophy,” Dr. Waibel concluded. Further studies are important to improve the understanding of “laser dosimetry, frequency of treatments, and longevity of effect. Collaboration between ob.gyns. and dermatologists is important as we learn about laser therapy in GSM.”
Dr. Waibel disclosed that she is a member of the advisory board of Sciton, which manufactures the diVa laser. She has also conducted clinical trials for many other device and pharmaceutical companies.
, results from a pilot trial showed.
“The genitourinary syndrome of menopause causes suffering in breast cancer survivors and postmenopausal women,” Jill S. Waibel, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. A common side effect for breast cancer survivors is early onset of menopause that is brought on by treatment, specifically aromatase-inhibitor therapies, she noted.
The symptoms of GSM include discomfort during sex, impaired sexual function, burning or sensation or irritation of the genital area, vaginal constriction, frequent urinary tract infections, urinary incontinence, and vaginal laxity, said Dr. Waibel, owner and medical director of the Miami Dermatology and Laser Institute. Nonhormonal treatments have included OTC vaginal lubricants, OTC moisturizers, low-dose vaginal estrogen – which increases the risk of breast cancer – and systemic estrogen therapy, which also can increase the risk of breast and endometrial cancer. “So, we need a healthy, nondrug option,” she said.
The objective of the pilot study was to determine the safety and efficacy of the diVa hybrid fractional laser as a treatment for symptoms of genitourinary syndrome of menopause, early menopause after breast cancer, or vaginal atrophy. The laser applies tunable nonablative (1,470-nm) and ablative (2,940-nm) wavelengths to the same microscopic treatment zone to maximize results and reduce downtime. The device features a motorized precision guidance system and calibrated rotation for homogeneous pulsing.
“The 2,940-nm wavelength is used to ablate to a depth of 0-800 micrometers while the 1,470-nm wavelength is used to coagulate the epithelium and the lamina propria at a depth of 100-700 micrometers,” said Dr. Waibel, who is also subsection chief of dermatology at Baptist Hospital of Miami. “This combination is used for epithelial tissue to heal quickly and the lamina propria to remodel slowly over time, laying down more collagen in tissue.” Each procedure is delivered via a single-use dilator, which expands the vaginal canal for increased treatment area. “The tip length is 5.5 cm and the diameter is 1 cm,” she said. “The clear tip acts as a hygienic barrier between the tip and the handpiece.”
Study participants included 25 women between the ages of 40 and 70 with early menopause after breast cancer or vaginal atrophy: 20 in the treatment arm and 5 in the sham-treatment arm. Dr. Waibel performed three procedures 2 weeks apart. An ob.gyn. assessed the primary endpoints, which included the Vaginal Health Index Scale (VHIS), the Vaginal Maturation Index (VMI), the Female Sexual Function Index (FSFI) questionnaire, and the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire. Secondary endpoints were histology and a satisfaction questionnaire.
Of the women in the treated group, there were data available for 19 at 3 months follow-up and 17 at 6 months follow-up. Based on the results in these patients, there were statistically significant improvements in nearly all domains of the FSFI treatment arm at 3 and 6 months when compared to baseline, especially arousal (P values of .05 at 3 months and .01 at 6 months) and lubrication (P values of .009 at three months and .001 at 6 months).
Between 3 and 6 months, patients in the treatment arm experienced improvements in four dimensions of the DIVA questionnaire: daily activities (P value of .01 at 3 months to .010 at 6 months), emotional well-being (P value of .06 at 3 months to .014 at 6 months), sexual function (P value of .30 at 3 months to .003 at 6 months), and self-concept/body image (P value of .002 at 3 months to .001 at 6 months).
As for satisfaction, a majority of those in the treatment arm were “somewhat satisfied” with the treatment and would “somewhat likely” repeat and recommend the treatment to friends and family, Dr. Waibel said. Results among the women in the control arm, who were also surveyed, were in the similar range, she noted. (No other results for women in the control arm were available.)
Following treatments, histology revealed that the collagen was denser, fibroblasts were more dense, and vascularity was more notable. No adverse events were observed. “The hybrid fractional laser is safe and effective for treating GSM, early menopause after breast cancer, or vaginal atrophy,” Dr. Waibel concluded. Further studies are important to improve the understanding of “laser dosimetry, frequency of treatments, and longevity of effect. Collaboration between ob.gyns. and dermatologists is important as we learn about laser therapy in GSM.”
Dr. Waibel disclosed that she is a member of the advisory board of Sciton, which manufactures the diVa laser. She has also conducted clinical trials for many other device and pharmaceutical companies.
, results from a pilot trial showed.
“The genitourinary syndrome of menopause causes suffering in breast cancer survivors and postmenopausal women,” Jill S. Waibel, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. A common side effect for breast cancer survivors is early onset of menopause that is brought on by treatment, specifically aromatase-inhibitor therapies, she noted.
The symptoms of GSM include discomfort during sex, impaired sexual function, burning or sensation or irritation of the genital area, vaginal constriction, frequent urinary tract infections, urinary incontinence, and vaginal laxity, said Dr. Waibel, owner and medical director of the Miami Dermatology and Laser Institute. Nonhormonal treatments have included OTC vaginal lubricants, OTC moisturizers, low-dose vaginal estrogen – which increases the risk of breast cancer – and systemic estrogen therapy, which also can increase the risk of breast and endometrial cancer. “So, we need a healthy, nondrug option,” she said.
The objective of the pilot study was to determine the safety and efficacy of the diVa hybrid fractional laser as a treatment for symptoms of genitourinary syndrome of menopause, early menopause after breast cancer, or vaginal atrophy. The laser applies tunable nonablative (1,470-nm) and ablative (2,940-nm) wavelengths to the same microscopic treatment zone to maximize results and reduce downtime. The device features a motorized precision guidance system and calibrated rotation for homogeneous pulsing.
“The 2,940-nm wavelength is used to ablate to a depth of 0-800 micrometers while the 1,470-nm wavelength is used to coagulate the epithelium and the lamina propria at a depth of 100-700 micrometers,” said Dr. Waibel, who is also subsection chief of dermatology at Baptist Hospital of Miami. “This combination is used for epithelial tissue to heal quickly and the lamina propria to remodel slowly over time, laying down more collagen in tissue.” Each procedure is delivered via a single-use dilator, which expands the vaginal canal for increased treatment area. “The tip length is 5.5 cm and the diameter is 1 cm,” she said. “The clear tip acts as a hygienic barrier between the tip and the handpiece.”
Study participants included 25 women between the ages of 40 and 70 with early menopause after breast cancer or vaginal atrophy: 20 in the treatment arm and 5 in the sham-treatment arm. Dr. Waibel performed three procedures 2 weeks apart. An ob.gyn. assessed the primary endpoints, which included the Vaginal Health Index Scale (VHIS), the Vaginal Maturation Index (VMI), the Female Sexual Function Index (FSFI) questionnaire, and the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire. Secondary endpoints were histology and a satisfaction questionnaire.
Of the women in the treated group, there were data available for 19 at 3 months follow-up and 17 at 6 months follow-up. Based on the results in these patients, there were statistically significant improvements in nearly all domains of the FSFI treatment arm at 3 and 6 months when compared to baseline, especially arousal (P values of .05 at 3 months and .01 at 6 months) and lubrication (P values of .009 at three months and .001 at 6 months).
Between 3 and 6 months, patients in the treatment arm experienced improvements in four dimensions of the DIVA questionnaire: daily activities (P value of .01 at 3 months to .010 at 6 months), emotional well-being (P value of .06 at 3 months to .014 at 6 months), sexual function (P value of .30 at 3 months to .003 at 6 months), and self-concept/body image (P value of .002 at 3 months to .001 at 6 months).
As for satisfaction, a majority of those in the treatment arm were “somewhat satisfied” with the treatment and would “somewhat likely” repeat and recommend the treatment to friends and family, Dr. Waibel said. Results among the women in the control arm, who were also surveyed, were in the similar range, she noted. (No other results for women in the control arm were available.)
Following treatments, histology revealed that the collagen was denser, fibroblasts were more dense, and vascularity was more notable. No adverse events were observed. “The hybrid fractional laser is safe and effective for treating GSM, early menopause after breast cancer, or vaginal atrophy,” Dr. Waibel concluded. Further studies are important to improve the understanding of “laser dosimetry, frequency of treatments, and longevity of effect. Collaboration between ob.gyns. and dermatologists is important as we learn about laser therapy in GSM.”
Dr. Waibel disclosed that she is a member of the advisory board of Sciton, which manufactures the diVa laser. She has also conducted clinical trials for many other device and pharmaceutical companies.
FROM ASLMS 2021
Trial yields evidence that laser resurfacing may prevent NMSC in aged skin
A on treated areas, according to the results of a small, randomized trial.
“Previous research suggests a new model to explain why older patients obtain nonmelanoma skin cancer in areas of ongoing sun exposure,” presenting author Jeffrey Wargo, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. “Insulinlike growth factor-1 produced by dermal fibroblasts dictates how overlying skin keratinocytes respond to UVB radiation. The skin of a patient aged in their 20s produces normal levels of healthy fibroblasts, normal levels of insulinlike growth factor 1, and appropriate UVB response via activation of nucleotide excision, repair, and DNA damage checkpoint-signaling systems.”
Older patients, meanwhile, have an increase in senescent fibroblasts, decreased insulinlike growth factor-1 (IGF-1), and an inappropriate UVB response to DNA damage, continued Dr. Wargo, a dermatologist at the Ohio State University Wexner Medical Center in Columbus. Previous studies conducted by his mentor, Jeffrey B. Travers, MD, PhD, a dermatologist and pharmacologist at Wright State University, Dayton, showed that fractionated laser resurfacing (FLR) restores UVB response in older patients’ skin by resulting in new fibroblasts and increased levels of IGF 2 years post wounding.
To determine if FLR of aged skin can prevent the development of actinic keratosis (AK) and nonmelanoma skin cancer, Dr. Travers and Dr. Wargo recruited 48 patients at the Dayton VA Medical Center who were 60 years or older and had at least five AKs on each arm that were 3 mm or smaller, with nothing concerning for skin cancer at the screening visit.
Randomization of which arm was treated was based on an odd or even Social Security Number. That arm was treated with the 2,790 nm Erbium:YSSG ablative laser at 120 J/m2 with one pass at 24% coverage from the elbow to hand dorsally. Previously published data reported outcomes for 30 of these patients at 3 and 6 months following treatment. Subsequent to that report, 18 additional subjects have been recruited to the study and follow-up has been extended. Of the 48 patients, 47 were male and their average age was 74, with a range between 61 and 87 years.
At 3 months following FLR, the ratio of AKs on the treated vs. untreated arms was reduced by fourfold, with a P value less than .00001, Dr. Wargo reported. “Throughout the current 30-month follow-up period, this ratio has been maintained,” he said. “In fact, none of the ratios determined at 3, 6, 12, 18, 24, or 30 months post FLR are significantly different. Hence, as described in our first report on this work, these data indicate FLR is an effective treatment for existing AKs. However, our model predicts that FLR treatment will also prevent the occurrence of new AK lesions.”
Among 19 of the study participants who have been followed out to 30 months, untreated arms continued to accumulate increasing number of AKs. In contrast, AKs on treated arms are decreasing with time, indicating the lack of newly initiated lesions.
“A second analysis of the data posits that, if FLR were only removing existing lesions, one would predict the number of AKs that were present at 3 months on both the untreated and FLR-treated [arms] would accumulate at the same rate subsequent to 3 months point in time,” Dr. Wargo said.
He pointed out that 12 patients were removed from the study: two at 12 months, one at 18 months, eight at 24 months, and one at 30 months, as they were found to have 20 or more AKs on their untreated arm and required treatment.
Over the entire study period, “consistent with the notion that FLR was preventing new actinic neoplasia, we noted a dramatic difference in numbers of nonmelanoma skin cancer diagnosed in the untreated areas (22) versus FLR treated areas (2),” Dr. Wargo said. The majority of nonmelanoma skin cancers diagnosed were SCC (17) and 5 basal cell carcinomas on the untreated arms, whereas the 2 diagnosed on the treated arm were SCC. “These studies indicate that a dermal-wounding strategy involving FLR, which upregulates dermal IGF-1 levels, not only treats AKs but prevents nonmelanoma skin cancer,” he said.
The study was funded by the National Institutes of Health. Dr. Travers is the principal investigator. Dr. Wargo reported having no financial disclosures.
A on treated areas, according to the results of a small, randomized trial.
“Previous research suggests a new model to explain why older patients obtain nonmelanoma skin cancer in areas of ongoing sun exposure,” presenting author Jeffrey Wargo, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. “Insulinlike growth factor-1 produced by dermal fibroblasts dictates how overlying skin keratinocytes respond to UVB radiation. The skin of a patient aged in their 20s produces normal levels of healthy fibroblasts, normal levels of insulinlike growth factor 1, and appropriate UVB response via activation of nucleotide excision, repair, and DNA damage checkpoint-signaling systems.”
Older patients, meanwhile, have an increase in senescent fibroblasts, decreased insulinlike growth factor-1 (IGF-1), and an inappropriate UVB response to DNA damage, continued Dr. Wargo, a dermatologist at the Ohio State University Wexner Medical Center in Columbus. Previous studies conducted by his mentor, Jeffrey B. Travers, MD, PhD, a dermatologist and pharmacologist at Wright State University, Dayton, showed that fractionated laser resurfacing (FLR) restores UVB response in older patients’ skin by resulting in new fibroblasts and increased levels of IGF 2 years post wounding.
To determine if FLR of aged skin can prevent the development of actinic keratosis (AK) and nonmelanoma skin cancer, Dr. Travers and Dr. Wargo recruited 48 patients at the Dayton VA Medical Center who were 60 years or older and had at least five AKs on each arm that were 3 mm or smaller, with nothing concerning for skin cancer at the screening visit.
Randomization of which arm was treated was based on an odd or even Social Security Number. That arm was treated with the 2,790 nm Erbium:YSSG ablative laser at 120 J/m2 with one pass at 24% coverage from the elbow to hand dorsally. Previously published data reported outcomes for 30 of these patients at 3 and 6 months following treatment. Subsequent to that report, 18 additional subjects have been recruited to the study and follow-up has been extended. Of the 48 patients, 47 were male and their average age was 74, with a range between 61 and 87 years.
At 3 months following FLR, the ratio of AKs on the treated vs. untreated arms was reduced by fourfold, with a P value less than .00001, Dr. Wargo reported. “Throughout the current 30-month follow-up period, this ratio has been maintained,” he said. “In fact, none of the ratios determined at 3, 6, 12, 18, 24, or 30 months post FLR are significantly different. Hence, as described in our first report on this work, these data indicate FLR is an effective treatment for existing AKs. However, our model predicts that FLR treatment will also prevent the occurrence of new AK lesions.”
Among 19 of the study participants who have been followed out to 30 months, untreated arms continued to accumulate increasing number of AKs. In contrast, AKs on treated arms are decreasing with time, indicating the lack of newly initiated lesions.
“A second analysis of the data posits that, if FLR were only removing existing lesions, one would predict the number of AKs that were present at 3 months on both the untreated and FLR-treated [arms] would accumulate at the same rate subsequent to 3 months point in time,” Dr. Wargo said.
He pointed out that 12 patients were removed from the study: two at 12 months, one at 18 months, eight at 24 months, and one at 30 months, as they were found to have 20 or more AKs on their untreated arm and required treatment.
Over the entire study period, “consistent with the notion that FLR was preventing new actinic neoplasia, we noted a dramatic difference in numbers of nonmelanoma skin cancer diagnosed in the untreated areas (22) versus FLR treated areas (2),” Dr. Wargo said. The majority of nonmelanoma skin cancers diagnosed were SCC (17) and 5 basal cell carcinomas on the untreated arms, whereas the 2 diagnosed on the treated arm were SCC. “These studies indicate that a dermal-wounding strategy involving FLR, which upregulates dermal IGF-1 levels, not only treats AKs but prevents nonmelanoma skin cancer,” he said.
The study was funded by the National Institutes of Health. Dr. Travers is the principal investigator. Dr. Wargo reported having no financial disclosures.
A on treated areas, according to the results of a small, randomized trial.
“Previous research suggests a new model to explain why older patients obtain nonmelanoma skin cancer in areas of ongoing sun exposure,” presenting author Jeffrey Wargo, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. “Insulinlike growth factor-1 produced by dermal fibroblasts dictates how overlying skin keratinocytes respond to UVB radiation. The skin of a patient aged in their 20s produces normal levels of healthy fibroblasts, normal levels of insulinlike growth factor 1, and appropriate UVB response via activation of nucleotide excision, repair, and DNA damage checkpoint-signaling systems.”
Older patients, meanwhile, have an increase in senescent fibroblasts, decreased insulinlike growth factor-1 (IGF-1), and an inappropriate UVB response to DNA damage, continued Dr. Wargo, a dermatologist at the Ohio State University Wexner Medical Center in Columbus. Previous studies conducted by his mentor, Jeffrey B. Travers, MD, PhD, a dermatologist and pharmacologist at Wright State University, Dayton, showed that fractionated laser resurfacing (FLR) restores UVB response in older patients’ skin by resulting in new fibroblasts and increased levels of IGF 2 years post wounding.
To determine if FLR of aged skin can prevent the development of actinic keratosis (AK) and nonmelanoma skin cancer, Dr. Travers and Dr. Wargo recruited 48 patients at the Dayton VA Medical Center who were 60 years or older and had at least five AKs on each arm that were 3 mm or smaller, with nothing concerning for skin cancer at the screening visit.
Randomization of which arm was treated was based on an odd or even Social Security Number. That arm was treated with the 2,790 nm Erbium:YSSG ablative laser at 120 J/m2 with one pass at 24% coverage from the elbow to hand dorsally. Previously published data reported outcomes for 30 of these patients at 3 and 6 months following treatment. Subsequent to that report, 18 additional subjects have been recruited to the study and follow-up has been extended. Of the 48 patients, 47 were male and their average age was 74, with a range between 61 and 87 years.
At 3 months following FLR, the ratio of AKs on the treated vs. untreated arms was reduced by fourfold, with a P value less than .00001, Dr. Wargo reported. “Throughout the current 30-month follow-up period, this ratio has been maintained,” he said. “In fact, none of the ratios determined at 3, 6, 12, 18, 24, or 30 months post FLR are significantly different. Hence, as described in our first report on this work, these data indicate FLR is an effective treatment for existing AKs. However, our model predicts that FLR treatment will also prevent the occurrence of new AK lesions.”
Among 19 of the study participants who have been followed out to 30 months, untreated arms continued to accumulate increasing number of AKs. In contrast, AKs on treated arms are decreasing with time, indicating the lack of newly initiated lesions.
“A second analysis of the data posits that, if FLR were only removing existing lesions, one would predict the number of AKs that were present at 3 months on both the untreated and FLR-treated [arms] would accumulate at the same rate subsequent to 3 months point in time,” Dr. Wargo said.
He pointed out that 12 patients were removed from the study: two at 12 months, one at 18 months, eight at 24 months, and one at 30 months, as they were found to have 20 or more AKs on their untreated arm and required treatment.
Over the entire study period, “consistent with the notion that FLR was preventing new actinic neoplasia, we noted a dramatic difference in numbers of nonmelanoma skin cancer diagnosed in the untreated areas (22) versus FLR treated areas (2),” Dr. Wargo said. The majority of nonmelanoma skin cancers diagnosed were SCC (17) and 5 basal cell carcinomas on the untreated arms, whereas the 2 diagnosed on the treated arm were SCC. “These studies indicate that a dermal-wounding strategy involving FLR, which upregulates dermal IGF-1 levels, not only treats AKs but prevents nonmelanoma skin cancer,” he said.
The study was funded by the National Institutes of Health. Dr. Travers is the principal investigator. Dr. Wargo reported having no financial disclosures.
FROM ASLMS 2021
One year after a single RAP treatment, patients give the results high marks
One year after a single treatment of cellulite with the Rapid Acoustic Pulse (RAP) device, 42 out of 43 patients said that they felt good about the results, an interim analysis from a multicenter study showed.
“I think this speaks to the duration of improvement” associated with this treatment, lead study author Elizabeth L. Tanzi, MD, said during the annual conference of the American Society for Laser Medicine and Surgery.
The study is an extension of a prospective pivotal clinical trial that Dr. Tanzi first presented during late-breaking abstract session at the 2020 virtual annual meeting of the American Academy of Dermatology. For the trial, she and her colleagues at four sites evaluated the safety and effectiveness of the RAP device in 62 women who were treated with a single, rapid acoustic pulse treatment comprised of 1-2 minutes on each identified dimple or large ridge of cellulite. In February 2021, the Food and Drug Administration cleared the device for the short-term improvement in the appearance of cellulite.
“The high peak pressure and fast repetition rate of this device will exploit the viscoelastic tissue compared to other acoustic wave devices that are on the market,” said Dr. Tanzi, associate clinical professor of dermatology at George Washington University, Washington. “Those compressed pulses from electronic filtering and reflector shape eliminate cavitation, heat, and pain. So, what we see physically is fiber septa disruption, as well as other nonthermal physical effects.”
She and her colleagues used a specific photography and fixed lighting setup to record the treated areas at baseline, 12 weeks, and 52 weeks, and administered a patient satisfaction questionnaire at 12 and 52 weeks. Prior to treatment, the investigators marked the dimples and ridges intended for treatment. After placing a hydrogel dressing, it took 45-60 minutes to treat both buttocks and thighs with the RAP device. “It was completely noninvasive,” said Dr. Tanzi, who practices in Chevy Chase, Md. “There was no anesthesia used: no incisions and no needles.”
Among 57 patients who were evaluated at 12 weeks, the pain score on a scale of 0-10 was 2.4, while 61.5% strongly agreed and 35.9% agreed that their cellulite appeared improved. In addition, three blinded assessors were able to correctly identify the treated thigh 96% of the time and physician-graded Global Aesthetic Improvement Scale assessments showed 90% improvement of cellulite.
Follow-up analysis
For the current subject satisfaction analysis, the investigators evaluated results from 43 patients in the trial who were followed for at least 52 weeks (a mean of 60 weeks). Of the 43 patients, 30 (69.8%) strongly agreed and 13 (30.2%) agreed that their cellulite “appears improved.” In addition, 29 (67.4%) strongly agreed, 13 (30.2%) agreed, and 1 (2.3%) disagreed with the statement “I feel there is good improvement” of their cellulite.
“Currently, we are evaluating the blinded assessors’ view of these patients and not just going with [findings from] the patient satisfaction survey, but I think these are encouraging results,” Dr. Tanzi said. “We found that 42 out of 43 patients said, ‘yes; I feel that there was good improvement of the area at 52 weeks.’ ”
Dr. Tanzi disclosed that she is a member of the speakers bureau for Eucerin. She is a member of the advisory board for Allergan, Endo Pharmaceuticals, Pulse Biosciences, Sciton, and Soliton. Soliton markets the RAP device.
One year after a single treatment of cellulite with the Rapid Acoustic Pulse (RAP) device, 42 out of 43 patients said that they felt good about the results, an interim analysis from a multicenter study showed.
“I think this speaks to the duration of improvement” associated with this treatment, lead study author Elizabeth L. Tanzi, MD, said during the annual conference of the American Society for Laser Medicine and Surgery.
The study is an extension of a prospective pivotal clinical trial that Dr. Tanzi first presented during late-breaking abstract session at the 2020 virtual annual meeting of the American Academy of Dermatology. For the trial, she and her colleagues at four sites evaluated the safety and effectiveness of the RAP device in 62 women who were treated with a single, rapid acoustic pulse treatment comprised of 1-2 minutes on each identified dimple or large ridge of cellulite. In February 2021, the Food and Drug Administration cleared the device for the short-term improvement in the appearance of cellulite.
“The high peak pressure and fast repetition rate of this device will exploit the viscoelastic tissue compared to other acoustic wave devices that are on the market,” said Dr. Tanzi, associate clinical professor of dermatology at George Washington University, Washington. “Those compressed pulses from electronic filtering and reflector shape eliminate cavitation, heat, and pain. So, what we see physically is fiber septa disruption, as well as other nonthermal physical effects.”
She and her colleagues used a specific photography and fixed lighting setup to record the treated areas at baseline, 12 weeks, and 52 weeks, and administered a patient satisfaction questionnaire at 12 and 52 weeks. Prior to treatment, the investigators marked the dimples and ridges intended for treatment. After placing a hydrogel dressing, it took 45-60 minutes to treat both buttocks and thighs with the RAP device. “It was completely noninvasive,” said Dr. Tanzi, who practices in Chevy Chase, Md. “There was no anesthesia used: no incisions and no needles.”
Among 57 patients who were evaluated at 12 weeks, the pain score on a scale of 0-10 was 2.4, while 61.5% strongly agreed and 35.9% agreed that their cellulite appeared improved. In addition, three blinded assessors were able to correctly identify the treated thigh 96% of the time and physician-graded Global Aesthetic Improvement Scale assessments showed 90% improvement of cellulite.
Follow-up analysis
For the current subject satisfaction analysis, the investigators evaluated results from 43 patients in the trial who were followed for at least 52 weeks (a mean of 60 weeks). Of the 43 patients, 30 (69.8%) strongly agreed and 13 (30.2%) agreed that their cellulite “appears improved.” In addition, 29 (67.4%) strongly agreed, 13 (30.2%) agreed, and 1 (2.3%) disagreed with the statement “I feel there is good improvement” of their cellulite.
“Currently, we are evaluating the blinded assessors’ view of these patients and not just going with [findings from] the patient satisfaction survey, but I think these are encouraging results,” Dr. Tanzi said. “We found that 42 out of 43 patients said, ‘yes; I feel that there was good improvement of the area at 52 weeks.’ ”
Dr. Tanzi disclosed that she is a member of the speakers bureau for Eucerin. She is a member of the advisory board for Allergan, Endo Pharmaceuticals, Pulse Biosciences, Sciton, and Soliton. Soliton markets the RAP device.
One year after a single treatment of cellulite with the Rapid Acoustic Pulse (RAP) device, 42 out of 43 patients said that they felt good about the results, an interim analysis from a multicenter study showed.
“I think this speaks to the duration of improvement” associated with this treatment, lead study author Elizabeth L. Tanzi, MD, said during the annual conference of the American Society for Laser Medicine and Surgery.
The study is an extension of a prospective pivotal clinical trial that Dr. Tanzi first presented during late-breaking abstract session at the 2020 virtual annual meeting of the American Academy of Dermatology. For the trial, she and her colleagues at four sites evaluated the safety and effectiveness of the RAP device in 62 women who were treated with a single, rapid acoustic pulse treatment comprised of 1-2 minutes on each identified dimple or large ridge of cellulite. In February 2021, the Food and Drug Administration cleared the device for the short-term improvement in the appearance of cellulite.
“The high peak pressure and fast repetition rate of this device will exploit the viscoelastic tissue compared to other acoustic wave devices that are on the market,” said Dr. Tanzi, associate clinical professor of dermatology at George Washington University, Washington. “Those compressed pulses from electronic filtering and reflector shape eliminate cavitation, heat, and pain. So, what we see physically is fiber septa disruption, as well as other nonthermal physical effects.”
She and her colleagues used a specific photography and fixed lighting setup to record the treated areas at baseline, 12 weeks, and 52 weeks, and administered a patient satisfaction questionnaire at 12 and 52 weeks. Prior to treatment, the investigators marked the dimples and ridges intended for treatment. After placing a hydrogel dressing, it took 45-60 minutes to treat both buttocks and thighs with the RAP device. “It was completely noninvasive,” said Dr. Tanzi, who practices in Chevy Chase, Md. “There was no anesthesia used: no incisions and no needles.”
Among 57 patients who were evaluated at 12 weeks, the pain score on a scale of 0-10 was 2.4, while 61.5% strongly agreed and 35.9% agreed that their cellulite appeared improved. In addition, three blinded assessors were able to correctly identify the treated thigh 96% of the time and physician-graded Global Aesthetic Improvement Scale assessments showed 90% improvement of cellulite.
Follow-up analysis
For the current subject satisfaction analysis, the investigators evaluated results from 43 patients in the trial who were followed for at least 52 weeks (a mean of 60 weeks). Of the 43 patients, 30 (69.8%) strongly agreed and 13 (30.2%) agreed that their cellulite “appears improved.” In addition, 29 (67.4%) strongly agreed, 13 (30.2%) agreed, and 1 (2.3%) disagreed with the statement “I feel there is good improvement” of their cellulite.
“Currently, we are evaluating the blinded assessors’ view of these patients and not just going with [findings from] the patient satisfaction survey, but I think these are encouraging results,” Dr. Tanzi said. “We found that 42 out of 43 patients said, ‘yes; I feel that there was good improvement of the area at 52 weeks.’ ”
Dr. Tanzi disclosed that she is a member of the speakers bureau for Eucerin. She is a member of the advisory board for Allergan, Endo Pharmaceuticals, Pulse Biosciences, Sciton, and Soliton. Soliton markets the RAP device.
FROM ASLMS 2021
FDA approves secukinumab in psoriasis patients age six and older
The who are candidates for systemic therapy or phototherapy. The expanded indication marks the first time the drug has been available for a pediatric population in the United States.
Children with plaque psoriasis are often undertreated because of fear of side effects of therapies, according to Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco. “Now, more and more medicines are being tested for safety and efficacy in children, and we no longer have to rely on adult studies to inform treatment choices for children,” Dr. Cordoro told this news organization.
The FDA approval of secukinumab for children aged 6 and older with moderate to severe psoriasis “is a welcome addition to the therapeutic toolbox for pediatric psoriasis,” she said. “We’ve entered an era where severe pediatric psoriasis has become a condition that can be adequately controlled with minimal risk and with the convenience of intermittent injections. This has changed the playing field for these children and their families completely. Given the potential short- and long-term negative impact of chronic inflammation on the body of a growing child, we now have approved treatments that can safely offset the risks of undertreated severe psoriasis on the functional and psychological health of the child.”
The approved pediatric dosing for secukinumab is 75 mg or 150 mg depending on the child’s weight at the time of dosing, and it is administered by subcutaneous injection every 4 weeks after an initial loading regimen. According to a press release from Novartis, the FDA approval came on the heels of two phase 3 studies that evaluated the use of secukinumab in children aged 6 to younger than 18 years with plaque psoriasis. The first was a 52-week, randomized, double-blind, placebo- and active-controlled study which included 162 children 6 years of age and older with severe plaque psoriasis. The doses evaluated were 75 mg for children who weighed less than 50 kg and 150 mg for those 50 kg or greater.
At week 12, the Psoriasis Area Severity Index (PASI)-75 response was 55% among children in the 75-mg dosing group vs. 10% in the placebo group and 86% in the 150-mg dosing group vs. 19% in the placebo group.
Meanwhile, the Investigator’s Global Assessment modified 2011 (IGA) “clear” response was achieved in 32% of children in the 75-mg dosing group vs. 5% in the placebo group and in 81% of children in the 150-mg dosing group vs. 5% in the placebo group. An IGA “almost clear” skin response was achieved in 81% of children in the 75-mg dosing group vs. 5% in the placebo group.
The second phase 3 study was a randomized open-label, 208-week trial of 84 subjects 6 years of age and older with moderate to severe plaque psoriasis. According to the Novartis press release, the safety profile reported in both trials was consistent with the safety profile reported in adult plaque psoriasis trials and no new safety signals were observed. The updated prescribing information for secukinumab can be found here.
“When considering treatment with a systemic agent such as a biologic, it is important to consider objective measures of severity, such as extent of disease and involvement of joints but also subjective indicators of severity such as impact beyond the skin on psychological well-being,” Dr. Cordoro said in the interview. “Kids with psoriasis in visible locations may socially isolate themselves due to embarrassment or bullying. Therefore, the impact of moderate to severe psoriasis not only on overall health but on self-esteem and identity formation can be significant, and therefore adequately treating children of all ages to prevent the downstream negative consequences of childhood psoriasis is critical.”
Dr. Cordoro reported having no financial disclosures.
The who are candidates for systemic therapy or phototherapy. The expanded indication marks the first time the drug has been available for a pediatric population in the United States.
Children with plaque psoriasis are often undertreated because of fear of side effects of therapies, according to Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco. “Now, more and more medicines are being tested for safety and efficacy in children, and we no longer have to rely on adult studies to inform treatment choices for children,” Dr. Cordoro told this news organization.
The FDA approval of secukinumab for children aged 6 and older with moderate to severe psoriasis “is a welcome addition to the therapeutic toolbox for pediatric psoriasis,” she said. “We’ve entered an era where severe pediatric psoriasis has become a condition that can be adequately controlled with minimal risk and with the convenience of intermittent injections. This has changed the playing field for these children and their families completely. Given the potential short- and long-term negative impact of chronic inflammation on the body of a growing child, we now have approved treatments that can safely offset the risks of undertreated severe psoriasis on the functional and psychological health of the child.”
The approved pediatric dosing for secukinumab is 75 mg or 150 mg depending on the child’s weight at the time of dosing, and it is administered by subcutaneous injection every 4 weeks after an initial loading regimen. According to a press release from Novartis, the FDA approval came on the heels of two phase 3 studies that evaluated the use of secukinumab in children aged 6 to younger than 18 years with plaque psoriasis. The first was a 52-week, randomized, double-blind, placebo- and active-controlled study which included 162 children 6 years of age and older with severe plaque psoriasis. The doses evaluated were 75 mg for children who weighed less than 50 kg and 150 mg for those 50 kg or greater.
At week 12, the Psoriasis Area Severity Index (PASI)-75 response was 55% among children in the 75-mg dosing group vs. 10% in the placebo group and 86% in the 150-mg dosing group vs. 19% in the placebo group.
Meanwhile, the Investigator’s Global Assessment modified 2011 (IGA) “clear” response was achieved in 32% of children in the 75-mg dosing group vs. 5% in the placebo group and in 81% of children in the 150-mg dosing group vs. 5% in the placebo group. An IGA “almost clear” skin response was achieved in 81% of children in the 75-mg dosing group vs. 5% in the placebo group.
The second phase 3 study was a randomized open-label, 208-week trial of 84 subjects 6 years of age and older with moderate to severe plaque psoriasis. According to the Novartis press release, the safety profile reported in both trials was consistent with the safety profile reported in adult plaque psoriasis trials and no new safety signals were observed. The updated prescribing information for secukinumab can be found here.
“When considering treatment with a systemic agent such as a biologic, it is important to consider objective measures of severity, such as extent of disease and involvement of joints but also subjective indicators of severity such as impact beyond the skin on psychological well-being,” Dr. Cordoro said in the interview. “Kids with psoriasis in visible locations may socially isolate themselves due to embarrassment or bullying. Therefore, the impact of moderate to severe psoriasis not only on overall health but on self-esteem and identity formation can be significant, and therefore adequately treating children of all ages to prevent the downstream negative consequences of childhood psoriasis is critical.”
Dr. Cordoro reported having no financial disclosures.
The who are candidates for systemic therapy or phototherapy. The expanded indication marks the first time the drug has been available for a pediatric population in the United States.
Children with plaque psoriasis are often undertreated because of fear of side effects of therapies, according to Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco. “Now, more and more medicines are being tested for safety and efficacy in children, and we no longer have to rely on adult studies to inform treatment choices for children,” Dr. Cordoro told this news organization.
The FDA approval of secukinumab for children aged 6 and older with moderate to severe psoriasis “is a welcome addition to the therapeutic toolbox for pediatric psoriasis,” she said. “We’ve entered an era where severe pediatric psoriasis has become a condition that can be adequately controlled with minimal risk and with the convenience of intermittent injections. This has changed the playing field for these children and their families completely. Given the potential short- and long-term negative impact of chronic inflammation on the body of a growing child, we now have approved treatments that can safely offset the risks of undertreated severe psoriasis on the functional and psychological health of the child.”
The approved pediatric dosing for secukinumab is 75 mg or 150 mg depending on the child’s weight at the time of dosing, and it is administered by subcutaneous injection every 4 weeks after an initial loading regimen. According to a press release from Novartis, the FDA approval came on the heels of two phase 3 studies that evaluated the use of secukinumab in children aged 6 to younger than 18 years with plaque psoriasis. The first was a 52-week, randomized, double-blind, placebo- and active-controlled study which included 162 children 6 years of age and older with severe plaque psoriasis. The doses evaluated were 75 mg for children who weighed less than 50 kg and 150 mg for those 50 kg or greater.
At week 12, the Psoriasis Area Severity Index (PASI)-75 response was 55% among children in the 75-mg dosing group vs. 10% in the placebo group and 86% in the 150-mg dosing group vs. 19% in the placebo group.
Meanwhile, the Investigator’s Global Assessment modified 2011 (IGA) “clear” response was achieved in 32% of children in the 75-mg dosing group vs. 5% in the placebo group and in 81% of children in the 150-mg dosing group vs. 5% in the placebo group. An IGA “almost clear” skin response was achieved in 81% of children in the 75-mg dosing group vs. 5% in the placebo group.
The second phase 3 study was a randomized open-label, 208-week trial of 84 subjects 6 years of age and older with moderate to severe plaque psoriasis. According to the Novartis press release, the safety profile reported in both trials was consistent with the safety profile reported in adult plaque psoriasis trials and no new safety signals were observed. The updated prescribing information for secukinumab can be found here.
“When considering treatment with a systemic agent such as a biologic, it is important to consider objective measures of severity, such as extent of disease and involvement of joints but also subjective indicators of severity such as impact beyond the skin on psychological well-being,” Dr. Cordoro said in the interview. “Kids with psoriasis in visible locations may socially isolate themselves due to embarrassment or bullying. Therefore, the impact of moderate to severe psoriasis not only on overall health but on self-esteem and identity formation can be significant, and therefore adequately treating children of all ages to prevent the downstream negative consequences of childhood psoriasis is critical.”
Dr. Cordoro reported having no financial disclosures.
Avoiding excess oxygen in mechanically ventilated patients ‘seems sensible’
The respiratory therapists at Mount Sinai Beth Israel, New York, know when Lina Miyakawa, MD, starts a week in the ICU, because she turns down the fraction of inspired oxygen (FiO2) levels if patients tolerate it.
“Hyperoxia in mechanical ventilation is a topic that’s near and dear to my heart,” Dr. Miyakawa, a pulmonary and critical care medicine specialist at Mount Sinai Beth Israel, said during SHM Converge, the annual conference of the Society of Hospital Medicine. “You can always find ‘wean down FiO2’ in my consult notes.”
While it is believed that humans have built up evolutionary defenses against hypoxia but not against hyperoxia, medical literature on the topic of hyperoxia with supplemental oxygen is fairly young. “In medical school we were taught to give oxygen for anybody with chest pain and concern about acute coronary syndrome,” she said. “This was until recent data suggested harm from liberal oxygen use.”
In a single-center trial of 434 critical care patients with an ICU length of stay of 72 hours or longer, Italian researchers examined the effects of a conservative protocol for oxygen therapy versus conventional therapy on ICU mortality (JAMA. 2016;316[15]:1583-9). The trial was stopped because the patients who were assigned to receive conservative therapy had a significantly lower mortality than the ones who received usual care (P = .01). “The study was not perfect, and the premature stoppage likely exaggerated the effect size,” said Dr. Miyakawa, who was not affiliated with the trial. “However, subsequent retrospective studies continue to support a benefit with conservative oxygen use, especially in different groups of patients. One of note is hyperoxia following cardiac arrest. There’s something called a two-hit model that speaks to worsening ischemia with reperfusion injury after the initial hypoxic event from the cardiac arrest itself” (See Intensive Care Med. 2015;41:534-6).
In a multicenter cohort study that drew from the Project IMPACT critical care database of ICUs at 120 U.S. hospitals between 2001 and 2005, researchers led by J. Hope Kilgannon, MD, tested the hypothesis that post-resuscitation hyperoxia is associated with increased in-hospital mortality (JAMA. 2010;303[21]:2165-71). The study population consisted of 6,326 patients who were divided into three groups: the hypoxic group (a PaO2 of less than 60 mm Hg); the normoxic group (a PaO2 of 60-299 mm Hg), and the hyperoxic group (a PaO2 of over 300 mm Hg). The mortality for the hyperoxic group was 63%, the hypoxic group at 57%, and the normoxic group at 45%.
More recently, the ICU-ROX Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group evaluated conservative versus liberal approaches in providing oxygen to 965 patients who were mechanically ventilated between 2015 and 2018 at 21 ICUs (N Eng J Med. 2020;382:989-98). Of the 965 patients, 484 were randomly assigned to the conservative oxygen group (defined as an SpO2 of 97% or lower) and 481 were assigned to the usual oxygen group (defined as having no specific measures limiting FiO2 or the SpO2). The primary outcome was the number of ventilator-free days from randomization until day 28, while the secondary outcome was mortality at 180 days. The researchers also performed a subgroup analysis of patients at risk for hypoxic-ischemic encephalopathy.
No significant differences were observed in the number of ventilator days between the two group (a median of 21 days in the conservative oxygen group versus 22 days in the usual oxygen group, respectively; P = .80) nor in mortality at 180 days (35.7% vs. 34.5%). However, in the subgroup analysis, patients with hypoxic-ischemic encephalopathy were noted to have more ventilator-free days (21 vs. 0 days), improved 180-day mortality (43% vs. 59%), and less functional impairment (55% vs. 68%) in the conservative-oxygen group.
“The results of this study suggest that conservative oxygen therapy has no additional advantage over standard oxygen therapy, but there may be benefits in those vulnerable to hyperoxia, which warrants further investigation,” Dr. Miyakawa said. “There are a few points to note on this topic. First, many of the previous studies had more liberal oxygen strategies than the ones used in this study, which could be the reason why we are seeing these results. In addition, O2 titration relies on imperfect approximations. PaO2 cannot be measured continuously; we really depend on the SpO2 on a minute-by-minute basis. Critically ill patients can also undergo episodes of hypoperfusion and shock state minute-by-minute. That’s when they’re at risk for hypoxemia. This would not be captured continuously with just O2 saturations.”
Dr. Miyakawa also highlighted the Liberal Oxygenation versus Conservative Oxygenation in Acute Respiratory Distress Syndrome trial (LOCO2) a prospective, multicenter, randomized, open-label trial involving patients with ARDS. It was carried out at 13 ICUs in France between June 2016 and September 2018 in an effort determine whether conservative oxygenation would reduce mortality at 28 days compared with the usual liberal-oxygen strategy (N Eng J Med. 2020;382:999-1008). The researchers detected a signal of increased mortality in the conservative oxygen group (34% vs. 27%), which led to a premature stoppage of the trial. “I’d like to postulate that the higher incidence of proning in the liberal oxygenation group compared to the conservative oxygen group (51% to 34%) may be the reason for the difference in mortality,” said Dr. Miyakawa, who was not affiliated with LOCO2. “This is supported from the 2013 PROSEVA Study Group, which reported that prone positioning in ARDS significantly decreases 28- and 90-day mortality” (see N Engl J Med. 2013; 368:2159-68).
She said that future trials on this topic “will have to address how a particular [oxygenation] target is both set and achieved in each group of patients, particularly those with specific organ injuries. In the meantime, in my opinion, avoiding excess oxygen seems sensible.”
Dr. Miyakawa reported having no financial disclosures.
The respiratory therapists at Mount Sinai Beth Israel, New York, know when Lina Miyakawa, MD, starts a week in the ICU, because she turns down the fraction of inspired oxygen (FiO2) levels if patients tolerate it.
“Hyperoxia in mechanical ventilation is a topic that’s near and dear to my heart,” Dr. Miyakawa, a pulmonary and critical care medicine specialist at Mount Sinai Beth Israel, said during SHM Converge, the annual conference of the Society of Hospital Medicine. “You can always find ‘wean down FiO2’ in my consult notes.”
While it is believed that humans have built up evolutionary defenses against hypoxia but not against hyperoxia, medical literature on the topic of hyperoxia with supplemental oxygen is fairly young. “In medical school we were taught to give oxygen for anybody with chest pain and concern about acute coronary syndrome,” she said. “This was until recent data suggested harm from liberal oxygen use.”
In a single-center trial of 434 critical care patients with an ICU length of stay of 72 hours or longer, Italian researchers examined the effects of a conservative protocol for oxygen therapy versus conventional therapy on ICU mortality (JAMA. 2016;316[15]:1583-9). The trial was stopped because the patients who were assigned to receive conservative therapy had a significantly lower mortality than the ones who received usual care (P = .01). “The study was not perfect, and the premature stoppage likely exaggerated the effect size,” said Dr. Miyakawa, who was not affiliated with the trial. “However, subsequent retrospective studies continue to support a benefit with conservative oxygen use, especially in different groups of patients. One of note is hyperoxia following cardiac arrest. There’s something called a two-hit model that speaks to worsening ischemia with reperfusion injury after the initial hypoxic event from the cardiac arrest itself” (See Intensive Care Med. 2015;41:534-6).
In a multicenter cohort study that drew from the Project IMPACT critical care database of ICUs at 120 U.S. hospitals between 2001 and 2005, researchers led by J. Hope Kilgannon, MD, tested the hypothesis that post-resuscitation hyperoxia is associated with increased in-hospital mortality (JAMA. 2010;303[21]:2165-71). The study population consisted of 6,326 patients who were divided into three groups: the hypoxic group (a PaO2 of less than 60 mm Hg); the normoxic group (a PaO2 of 60-299 mm Hg), and the hyperoxic group (a PaO2 of over 300 mm Hg). The mortality for the hyperoxic group was 63%, the hypoxic group at 57%, and the normoxic group at 45%.
More recently, the ICU-ROX Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group evaluated conservative versus liberal approaches in providing oxygen to 965 patients who were mechanically ventilated between 2015 and 2018 at 21 ICUs (N Eng J Med. 2020;382:989-98). Of the 965 patients, 484 were randomly assigned to the conservative oxygen group (defined as an SpO2 of 97% or lower) and 481 were assigned to the usual oxygen group (defined as having no specific measures limiting FiO2 or the SpO2). The primary outcome was the number of ventilator-free days from randomization until day 28, while the secondary outcome was mortality at 180 days. The researchers also performed a subgroup analysis of patients at risk for hypoxic-ischemic encephalopathy.
No significant differences were observed in the number of ventilator days between the two group (a median of 21 days in the conservative oxygen group versus 22 days in the usual oxygen group, respectively; P = .80) nor in mortality at 180 days (35.7% vs. 34.5%). However, in the subgroup analysis, patients with hypoxic-ischemic encephalopathy were noted to have more ventilator-free days (21 vs. 0 days), improved 180-day mortality (43% vs. 59%), and less functional impairment (55% vs. 68%) in the conservative-oxygen group.
“The results of this study suggest that conservative oxygen therapy has no additional advantage over standard oxygen therapy, but there may be benefits in those vulnerable to hyperoxia, which warrants further investigation,” Dr. Miyakawa said. “There are a few points to note on this topic. First, many of the previous studies had more liberal oxygen strategies than the ones used in this study, which could be the reason why we are seeing these results. In addition, O2 titration relies on imperfect approximations. PaO2 cannot be measured continuously; we really depend on the SpO2 on a minute-by-minute basis. Critically ill patients can also undergo episodes of hypoperfusion and shock state minute-by-minute. That’s when they’re at risk for hypoxemia. This would not be captured continuously with just O2 saturations.”
Dr. Miyakawa also highlighted the Liberal Oxygenation versus Conservative Oxygenation in Acute Respiratory Distress Syndrome trial (LOCO2) a prospective, multicenter, randomized, open-label trial involving patients with ARDS. It was carried out at 13 ICUs in France between June 2016 and September 2018 in an effort determine whether conservative oxygenation would reduce mortality at 28 days compared with the usual liberal-oxygen strategy (N Eng J Med. 2020;382:999-1008). The researchers detected a signal of increased mortality in the conservative oxygen group (34% vs. 27%), which led to a premature stoppage of the trial. “I’d like to postulate that the higher incidence of proning in the liberal oxygenation group compared to the conservative oxygen group (51% to 34%) may be the reason for the difference in mortality,” said Dr. Miyakawa, who was not affiliated with LOCO2. “This is supported from the 2013 PROSEVA Study Group, which reported that prone positioning in ARDS significantly decreases 28- and 90-day mortality” (see N Engl J Med. 2013; 368:2159-68).
She said that future trials on this topic “will have to address how a particular [oxygenation] target is both set and achieved in each group of patients, particularly those with specific organ injuries. In the meantime, in my opinion, avoiding excess oxygen seems sensible.”
Dr. Miyakawa reported having no financial disclosures.
The respiratory therapists at Mount Sinai Beth Israel, New York, know when Lina Miyakawa, MD, starts a week in the ICU, because she turns down the fraction of inspired oxygen (FiO2) levels if patients tolerate it.
“Hyperoxia in mechanical ventilation is a topic that’s near and dear to my heart,” Dr. Miyakawa, a pulmonary and critical care medicine specialist at Mount Sinai Beth Israel, said during SHM Converge, the annual conference of the Society of Hospital Medicine. “You can always find ‘wean down FiO2’ in my consult notes.”
While it is believed that humans have built up evolutionary defenses against hypoxia but not against hyperoxia, medical literature on the topic of hyperoxia with supplemental oxygen is fairly young. “In medical school we were taught to give oxygen for anybody with chest pain and concern about acute coronary syndrome,” she said. “This was until recent data suggested harm from liberal oxygen use.”
In a single-center trial of 434 critical care patients with an ICU length of stay of 72 hours or longer, Italian researchers examined the effects of a conservative protocol for oxygen therapy versus conventional therapy on ICU mortality (JAMA. 2016;316[15]:1583-9). The trial was stopped because the patients who were assigned to receive conservative therapy had a significantly lower mortality than the ones who received usual care (P = .01). “The study was not perfect, and the premature stoppage likely exaggerated the effect size,” said Dr. Miyakawa, who was not affiliated with the trial. “However, subsequent retrospective studies continue to support a benefit with conservative oxygen use, especially in different groups of patients. One of note is hyperoxia following cardiac arrest. There’s something called a two-hit model that speaks to worsening ischemia with reperfusion injury after the initial hypoxic event from the cardiac arrest itself” (See Intensive Care Med. 2015;41:534-6).
In a multicenter cohort study that drew from the Project IMPACT critical care database of ICUs at 120 U.S. hospitals between 2001 and 2005, researchers led by J. Hope Kilgannon, MD, tested the hypothesis that post-resuscitation hyperoxia is associated with increased in-hospital mortality (JAMA. 2010;303[21]:2165-71). The study population consisted of 6,326 patients who were divided into three groups: the hypoxic group (a PaO2 of less than 60 mm Hg); the normoxic group (a PaO2 of 60-299 mm Hg), and the hyperoxic group (a PaO2 of over 300 mm Hg). The mortality for the hyperoxic group was 63%, the hypoxic group at 57%, and the normoxic group at 45%.
More recently, the ICU-ROX Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group evaluated conservative versus liberal approaches in providing oxygen to 965 patients who were mechanically ventilated between 2015 and 2018 at 21 ICUs (N Eng J Med. 2020;382:989-98). Of the 965 patients, 484 were randomly assigned to the conservative oxygen group (defined as an SpO2 of 97% or lower) and 481 were assigned to the usual oxygen group (defined as having no specific measures limiting FiO2 or the SpO2). The primary outcome was the number of ventilator-free days from randomization until day 28, while the secondary outcome was mortality at 180 days. The researchers also performed a subgroup analysis of patients at risk for hypoxic-ischemic encephalopathy.
No significant differences were observed in the number of ventilator days between the two group (a median of 21 days in the conservative oxygen group versus 22 days in the usual oxygen group, respectively; P = .80) nor in mortality at 180 days (35.7% vs. 34.5%). However, in the subgroup analysis, patients with hypoxic-ischemic encephalopathy were noted to have more ventilator-free days (21 vs. 0 days), improved 180-day mortality (43% vs. 59%), and less functional impairment (55% vs. 68%) in the conservative-oxygen group.
“The results of this study suggest that conservative oxygen therapy has no additional advantage over standard oxygen therapy, but there may be benefits in those vulnerable to hyperoxia, which warrants further investigation,” Dr. Miyakawa said. “There are a few points to note on this topic. First, many of the previous studies had more liberal oxygen strategies than the ones used in this study, which could be the reason why we are seeing these results. In addition, O2 titration relies on imperfect approximations. PaO2 cannot be measured continuously; we really depend on the SpO2 on a minute-by-minute basis. Critically ill patients can also undergo episodes of hypoperfusion and shock state minute-by-minute. That’s when they’re at risk for hypoxemia. This would not be captured continuously with just O2 saturations.”
Dr. Miyakawa also highlighted the Liberal Oxygenation versus Conservative Oxygenation in Acute Respiratory Distress Syndrome trial (LOCO2) a prospective, multicenter, randomized, open-label trial involving patients with ARDS. It was carried out at 13 ICUs in France between June 2016 and September 2018 in an effort determine whether conservative oxygenation would reduce mortality at 28 days compared with the usual liberal-oxygen strategy (N Eng J Med. 2020;382:999-1008). The researchers detected a signal of increased mortality in the conservative oxygen group (34% vs. 27%), which led to a premature stoppage of the trial. “I’d like to postulate that the higher incidence of proning in the liberal oxygenation group compared to the conservative oxygen group (51% to 34%) may be the reason for the difference in mortality,” said Dr. Miyakawa, who was not affiliated with LOCO2. “This is supported from the 2013 PROSEVA Study Group, which reported that prone positioning in ARDS significantly decreases 28- and 90-day mortality” (see N Engl J Med. 2013; 368:2159-68).
She said that future trials on this topic “will have to address how a particular [oxygenation] target is both set and achieved in each group of patients, particularly those with specific organ injuries. In the meantime, in my opinion, avoiding excess oxygen seems sensible.”
Dr. Miyakawa reported having no financial disclosures.
FROM SHM CONVERGE 2021
How early can laser treatment for port wine stains in infants be initiated?
without any complications, results from a single-center study showed.
“The current modality of choice for the treatment of port wine birthmarks is pulsed dye laser,” Chelsea Grimes Fidai, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. “When performed by a highly trained expert at efficient frequencies, PDL is a safe, effective treatment that is successful in the majority of patients. We know that earlier treatment yields maximal clearance. However, just how early can you initiate treatment?”
To find out, Dr. Fidai, Roy G. Geronemus, MD, and colleagues at the Laser and Skin Surgery Center of New York, conducted a retrospective chart review of 39 infants with port wine birthmarks who were treated with a 595-nm PDL between 2015 and 2020 at the center. Of the 39 infants, the average age at first treatment was 18 days, with a range from 5 to 29 days. The youngest patient was born prematurely at 35 weeks’ gestation and presented for his first treatment even before his expected due date. Most (74%) had facial lesions with the remaining distributed on the trunk or extremities. The average number of treatments was 15 over the course of 15 months.
The initial settings chosen for facial lesions were a 10-mm spot size, a fluence of 8.0 J/cm2, and a 1.5-millisecond pulse duration. For body lesions, the typical initial settings were a 12-mm spot size, a fluence of 6.7 J/cm2, and 1.5-millisecond pulse duration. Corneal eye shields were placed for all cases with port wine birthmarks approaching the eyelid. “We do recommend a treatment interval of every 2-3 weeks, with longer intervals for patients of darker skin type until the child is 2 years old, at which time the interval is increased to every 3-6 months,” said Dr. Fidai.
Patients in the study experienced the expected short-term side effects of erythema, edema, purpura, and mild transient postinflammatory hyperpigmentation, but there were no cases of atrophy, scarring, infection, or permanent pigmentary change.
“Families seeking early treatment of port wine birthmarks can be reassured that it can be safely initiated within the first few days after birth,” Dr. Fidai concluded. “This procedure can be quickly and confidently performed as an in-office procedure without any complications. The early intervention allows for treatment without general anesthesia and it maximizes the chance of significant clearance as early in life as possible.”
During a question-and-answer session, the abstract section chair, Albert Wolkerstorfer, MD, PhD, expressed concern about the effect of PDL on developing infants. “We do repeated treatments at this young age without any type of anesthesia,” said Dr. Wolkerstorfer, a dermatologist at the Netherlands Institute for Pigment Disorders, department of dermatology, University of Amsterdam.
“Will that influence the development of the child, especially when I hear there might be 15 or 20 treatments done within the first year of life? I think this is a problem where we need to ask the experts in the field of pain management in children, like pediatric anesthesiologists, to find the right way, because I think that the results that you showed are fantastic. I don’t think we can achieve that at a later age, although there’s no direct comparison at this moment.”
Dr. Fidai said that she understood the concern, but pointed to a 2020 article by Dr. Geronemus and colleagues that assessed treatment tolerance and parental perspective of outpatient PDL treatment for port-wine birthmarks without general anesthesia in infants and toddlers. “The kids recover pretty quickly after the treatment,” she said. “There has never been any longstanding issue from the parents’ perspective.”
Dr. Fidai reported having no financial disclosures. Dr. Geronemus disclosed having financial conflicts with numerous device and pharmaceutical companies. Dr. Wolkerstorfer disclosed that he has received consulting fees from Lumenis and InCyte and equipment from Humeca and PerfAction Technologies. He has also received grant funding from Novartis and InCyte and he is a member of InCyte’s advisory board.
without any complications, results from a single-center study showed.
“The current modality of choice for the treatment of port wine birthmarks is pulsed dye laser,” Chelsea Grimes Fidai, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. “When performed by a highly trained expert at efficient frequencies, PDL is a safe, effective treatment that is successful in the majority of patients. We know that earlier treatment yields maximal clearance. However, just how early can you initiate treatment?”
To find out, Dr. Fidai, Roy G. Geronemus, MD, and colleagues at the Laser and Skin Surgery Center of New York, conducted a retrospective chart review of 39 infants with port wine birthmarks who were treated with a 595-nm PDL between 2015 and 2020 at the center. Of the 39 infants, the average age at first treatment was 18 days, with a range from 5 to 29 days. The youngest patient was born prematurely at 35 weeks’ gestation and presented for his first treatment even before his expected due date. Most (74%) had facial lesions with the remaining distributed on the trunk or extremities. The average number of treatments was 15 over the course of 15 months.
The initial settings chosen for facial lesions were a 10-mm spot size, a fluence of 8.0 J/cm2, and a 1.5-millisecond pulse duration. For body lesions, the typical initial settings were a 12-mm spot size, a fluence of 6.7 J/cm2, and 1.5-millisecond pulse duration. Corneal eye shields were placed for all cases with port wine birthmarks approaching the eyelid. “We do recommend a treatment interval of every 2-3 weeks, with longer intervals for patients of darker skin type until the child is 2 years old, at which time the interval is increased to every 3-6 months,” said Dr. Fidai.
Patients in the study experienced the expected short-term side effects of erythema, edema, purpura, and mild transient postinflammatory hyperpigmentation, but there were no cases of atrophy, scarring, infection, or permanent pigmentary change.
“Families seeking early treatment of port wine birthmarks can be reassured that it can be safely initiated within the first few days after birth,” Dr. Fidai concluded. “This procedure can be quickly and confidently performed as an in-office procedure without any complications. The early intervention allows for treatment without general anesthesia and it maximizes the chance of significant clearance as early in life as possible.”
During a question-and-answer session, the abstract section chair, Albert Wolkerstorfer, MD, PhD, expressed concern about the effect of PDL on developing infants. “We do repeated treatments at this young age without any type of anesthesia,” said Dr. Wolkerstorfer, a dermatologist at the Netherlands Institute for Pigment Disorders, department of dermatology, University of Amsterdam.
“Will that influence the development of the child, especially when I hear there might be 15 or 20 treatments done within the first year of life? I think this is a problem where we need to ask the experts in the field of pain management in children, like pediatric anesthesiologists, to find the right way, because I think that the results that you showed are fantastic. I don’t think we can achieve that at a later age, although there’s no direct comparison at this moment.”
Dr. Fidai said that she understood the concern, but pointed to a 2020 article by Dr. Geronemus and colleagues that assessed treatment tolerance and parental perspective of outpatient PDL treatment for port-wine birthmarks without general anesthesia in infants and toddlers. “The kids recover pretty quickly after the treatment,” she said. “There has never been any longstanding issue from the parents’ perspective.”
Dr. Fidai reported having no financial disclosures. Dr. Geronemus disclosed having financial conflicts with numerous device and pharmaceutical companies. Dr. Wolkerstorfer disclosed that he has received consulting fees from Lumenis and InCyte and equipment from Humeca and PerfAction Technologies. He has also received grant funding from Novartis and InCyte and he is a member of InCyte’s advisory board.
without any complications, results from a single-center study showed.
“The current modality of choice for the treatment of port wine birthmarks is pulsed dye laser,” Chelsea Grimes Fidai, MD, said during the annual conference of the American Society for Laser Medicine and Surgery. “When performed by a highly trained expert at efficient frequencies, PDL is a safe, effective treatment that is successful in the majority of patients. We know that earlier treatment yields maximal clearance. However, just how early can you initiate treatment?”
To find out, Dr. Fidai, Roy G. Geronemus, MD, and colleagues at the Laser and Skin Surgery Center of New York, conducted a retrospective chart review of 39 infants with port wine birthmarks who were treated with a 595-nm PDL between 2015 and 2020 at the center. Of the 39 infants, the average age at first treatment was 18 days, with a range from 5 to 29 days. The youngest patient was born prematurely at 35 weeks’ gestation and presented for his first treatment even before his expected due date. Most (74%) had facial lesions with the remaining distributed on the trunk or extremities. The average number of treatments was 15 over the course of 15 months.
The initial settings chosen for facial lesions were a 10-mm spot size, a fluence of 8.0 J/cm2, and a 1.5-millisecond pulse duration. For body lesions, the typical initial settings were a 12-mm spot size, a fluence of 6.7 J/cm2, and 1.5-millisecond pulse duration. Corneal eye shields were placed for all cases with port wine birthmarks approaching the eyelid. “We do recommend a treatment interval of every 2-3 weeks, with longer intervals for patients of darker skin type until the child is 2 years old, at which time the interval is increased to every 3-6 months,” said Dr. Fidai.
Patients in the study experienced the expected short-term side effects of erythema, edema, purpura, and mild transient postinflammatory hyperpigmentation, but there were no cases of atrophy, scarring, infection, or permanent pigmentary change.
“Families seeking early treatment of port wine birthmarks can be reassured that it can be safely initiated within the first few days after birth,” Dr. Fidai concluded. “This procedure can be quickly and confidently performed as an in-office procedure without any complications. The early intervention allows for treatment without general anesthesia and it maximizes the chance of significant clearance as early in life as possible.”
During a question-and-answer session, the abstract section chair, Albert Wolkerstorfer, MD, PhD, expressed concern about the effect of PDL on developing infants. “We do repeated treatments at this young age without any type of anesthesia,” said Dr. Wolkerstorfer, a dermatologist at the Netherlands Institute for Pigment Disorders, department of dermatology, University of Amsterdam.
“Will that influence the development of the child, especially when I hear there might be 15 or 20 treatments done within the first year of life? I think this is a problem where we need to ask the experts in the field of pain management in children, like pediatric anesthesiologists, to find the right way, because I think that the results that you showed are fantastic. I don’t think we can achieve that at a later age, although there’s no direct comparison at this moment.”
Dr. Fidai said that she understood the concern, but pointed to a 2020 article by Dr. Geronemus and colleagues that assessed treatment tolerance and parental perspective of outpatient PDL treatment for port-wine birthmarks without general anesthesia in infants and toddlers. “The kids recover pretty quickly after the treatment,” she said. “There has never been any longstanding issue from the parents’ perspective.”
Dr. Fidai reported having no financial disclosures. Dr. Geronemus disclosed having financial conflicts with numerous device and pharmaceutical companies. Dr. Wolkerstorfer disclosed that he has received consulting fees from Lumenis and InCyte and equipment from Humeca and PerfAction Technologies. He has also received grant funding from Novartis and InCyte and he is a member of InCyte’s advisory board.
FROM ASLMS 2021
Review finds diverse outcomes in clinical trials of rosacea
according to authors of a new systematic review of rosacea treatment studies.
“Rosacea is a chronic dermatologic condition that affects 16 million Americans,” one of the study authors, Sarah A. Ibrahim, told this news organization after the annual conference of the American Society for Laser Medicine and Surgery. “The features of rosacea, such as inflammatory lesions, redness, burning sensations, and swelling, can have a negative impact on the quality of life for many patients. Additionally, patients with rosacea are at an increased risk for other conditions such as autoimmune diseases, like inflammatory bowel disease.”
In an effort led by principal investigator Murad Alam, MD, vice chair of the department of dermatology at Northwestern University, Chicago, Ms. Ibrahim conducted a systematic review to identify all outcomes that have previously been reported in clinical trials of rosacea, as part of the development of the core outcome set established by the Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) group. “This has not been done before and is an important first step in understanding what outcomes should be measured in every future clinical study of rosacea,” said Ms. Ibrahim, a medical student at Northwestern University, and predoctoral research fellow in Northwestern’s department of dermatology.
The researchers limited their analysis to randomized, controlled trials of rosacea interventions published between 2010 and 2020 and categorized outcomes into domains based on similar themes.
A total of 58 studies were included in the systematic review, of which 7 (12%) evaluated laser-based interventions. The researchers identified 55 unique outcomes that encompassed eight domains: Quality of life, treatment effects, patient perception of health, clinical assessment, acceptance of care, laboratory assessment, physiological skin assessment, and patient satisfaction. Of the eight domains, clinical assessment-related outcomes were measured in all studies. Nontransient erythema was the most commonly reported outcome (43 studies, 78%), followed by inflammatory lesions (36 studies, 65%) and telangiectasia (22 studies, 40%).
Outcomes pertaining to treatment effects such as adverse events were measured in 49 of the 55 studies (89%), while patient-reported outcomes were measured in 21 (38%). Quality of life and patient satisfaction were reported in 18 (33%) and 13 (24%) studies, respectively.
“There were two main take-home messages of our study,” said Ms. Ibrahim, who presented the results at the meeting. “The first is that there is a wide range of outcomes that are reported in clinical trials of rosacea therapies. Second, that there is a need to standardize the outcomes that are reported in clinical trials of rosacea, in order to be able to combine the results from different studies to better understand which interventions for rosacea are most effective.”
She acknowledged certain limitations of the review, including that other trials related to the topic were not included. “Because of the date range and types of studies that we used to narrow down our search, it is possible that additional outcomes were reported in studies that were not included here,” she said.
“This is a very important study because rosacea is a very common condition and one that I have seen more frequently in clinic since the pandemic started,” said Omar Ibrahimi, PhD, MD, a dermatologist with the Connecticut Skin Institute in Stamford, who was asked to comment on the work. “One of the limitations with rosacea studies is that the studies done are often fairly small and the outcome measures are heterogenous. The current study by Ibrahim and coworkers does a wonderful job of highlighting the various outcomes measures used to measure the success of rosacea treatments with energy-based devices.”
This information, he added, “will be very useful for further research studies because it forms the basis for formulating a set of core outcome measures to judge treatment interventions with consensus input from a variety of key opinion leaders. This will prove to be valuable because if we can have a uniform set of outcome measures to judge rosacea treatments with then we will be able to compare the results from different studies better.”
Ms. Ibrahim and colleagues reported having no relevant financial disclosures. Dr. Ibrahimi disclosed that he has been a speaker for both Candela and Cutera and he is currently on the medical advisory board for Cutera.
according to authors of a new systematic review of rosacea treatment studies.
“Rosacea is a chronic dermatologic condition that affects 16 million Americans,” one of the study authors, Sarah A. Ibrahim, told this news organization after the annual conference of the American Society for Laser Medicine and Surgery. “The features of rosacea, such as inflammatory lesions, redness, burning sensations, and swelling, can have a negative impact on the quality of life for many patients. Additionally, patients with rosacea are at an increased risk for other conditions such as autoimmune diseases, like inflammatory bowel disease.”
In an effort led by principal investigator Murad Alam, MD, vice chair of the department of dermatology at Northwestern University, Chicago, Ms. Ibrahim conducted a systematic review to identify all outcomes that have previously been reported in clinical trials of rosacea, as part of the development of the core outcome set established by the Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) group. “This has not been done before and is an important first step in understanding what outcomes should be measured in every future clinical study of rosacea,” said Ms. Ibrahim, a medical student at Northwestern University, and predoctoral research fellow in Northwestern’s department of dermatology.
The researchers limited their analysis to randomized, controlled trials of rosacea interventions published between 2010 and 2020 and categorized outcomes into domains based on similar themes.
A total of 58 studies were included in the systematic review, of which 7 (12%) evaluated laser-based interventions. The researchers identified 55 unique outcomes that encompassed eight domains: Quality of life, treatment effects, patient perception of health, clinical assessment, acceptance of care, laboratory assessment, physiological skin assessment, and patient satisfaction. Of the eight domains, clinical assessment-related outcomes were measured in all studies. Nontransient erythema was the most commonly reported outcome (43 studies, 78%), followed by inflammatory lesions (36 studies, 65%) and telangiectasia (22 studies, 40%).
Outcomes pertaining to treatment effects such as adverse events were measured in 49 of the 55 studies (89%), while patient-reported outcomes were measured in 21 (38%). Quality of life and patient satisfaction were reported in 18 (33%) and 13 (24%) studies, respectively.
“There were two main take-home messages of our study,” said Ms. Ibrahim, who presented the results at the meeting. “The first is that there is a wide range of outcomes that are reported in clinical trials of rosacea therapies. Second, that there is a need to standardize the outcomes that are reported in clinical trials of rosacea, in order to be able to combine the results from different studies to better understand which interventions for rosacea are most effective.”
She acknowledged certain limitations of the review, including that other trials related to the topic were not included. “Because of the date range and types of studies that we used to narrow down our search, it is possible that additional outcomes were reported in studies that were not included here,” she said.
“This is a very important study because rosacea is a very common condition and one that I have seen more frequently in clinic since the pandemic started,” said Omar Ibrahimi, PhD, MD, a dermatologist with the Connecticut Skin Institute in Stamford, who was asked to comment on the work. “One of the limitations with rosacea studies is that the studies done are often fairly small and the outcome measures are heterogenous. The current study by Ibrahim and coworkers does a wonderful job of highlighting the various outcomes measures used to measure the success of rosacea treatments with energy-based devices.”
This information, he added, “will be very useful for further research studies because it forms the basis for formulating a set of core outcome measures to judge treatment interventions with consensus input from a variety of key opinion leaders. This will prove to be valuable because if we can have a uniform set of outcome measures to judge rosacea treatments with then we will be able to compare the results from different studies better.”
Ms. Ibrahim and colleagues reported having no relevant financial disclosures. Dr. Ibrahimi disclosed that he has been a speaker for both Candela and Cutera and he is currently on the medical advisory board for Cutera.
according to authors of a new systematic review of rosacea treatment studies.
“Rosacea is a chronic dermatologic condition that affects 16 million Americans,” one of the study authors, Sarah A. Ibrahim, told this news organization after the annual conference of the American Society for Laser Medicine and Surgery. “The features of rosacea, such as inflammatory lesions, redness, burning sensations, and swelling, can have a negative impact on the quality of life for many patients. Additionally, patients with rosacea are at an increased risk for other conditions such as autoimmune diseases, like inflammatory bowel disease.”
In an effort led by principal investigator Murad Alam, MD, vice chair of the department of dermatology at Northwestern University, Chicago, Ms. Ibrahim conducted a systematic review to identify all outcomes that have previously been reported in clinical trials of rosacea, as part of the development of the core outcome set established by the Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) group. “This has not been done before and is an important first step in understanding what outcomes should be measured in every future clinical study of rosacea,” said Ms. Ibrahim, a medical student at Northwestern University, and predoctoral research fellow in Northwestern’s department of dermatology.
The researchers limited their analysis to randomized, controlled trials of rosacea interventions published between 2010 and 2020 and categorized outcomes into domains based on similar themes.
A total of 58 studies were included in the systematic review, of which 7 (12%) evaluated laser-based interventions. The researchers identified 55 unique outcomes that encompassed eight domains: Quality of life, treatment effects, patient perception of health, clinical assessment, acceptance of care, laboratory assessment, physiological skin assessment, and patient satisfaction. Of the eight domains, clinical assessment-related outcomes were measured in all studies. Nontransient erythema was the most commonly reported outcome (43 studies, 78%), followed by inflammatory lesions (36 studies, 65%) and telangiectasia (22 studies, 40%).
Outcomes pertaining to treatment effects such as adverse events were measured in 49 of the 55 studies (89%), while patient-reported outcomes were measured in 21 (38%). Quality of life and patient satisfaction were reported in 18 (33%) and 13 (24%) studies, respectively.
“There were two main take-home messages of our study,” said Ms. Ibrahim, who presented the results at the meeting. “The first is that there is a wide range of outcomes that are reported in clinical trials of rosacea therapies. Second, that there is a need to standardize the outcomes that are reported in clinical trials of rosacea, in order to be able to combine the results from different studies to better understand which interventions for rosacea are most effective.”
She acknowledged certain limitations of the review, including that other trials related to the topic were not included. “Because of the date range and types of studies that we used to narrow down our search, it is possible that additional outcomes were reported in studies that were not included here,” she said.
“This is a very important study because rosacea is a very common condition and one that I have seen more frequently in clinic since the pandemic started,” said Omar Ibrahimi, PhD, MD, a dermatologist with the Connecticut Skin Institute in Stamford, who was asked to comment on the work. “One of the limitations with rosacea studies is that the studies done are often fairly small and the outcome measures are heterogenous. The current study by Ibrahim and coworkers does a wonderful job of highlighting the various outcomes measures used to measure the success of rosacea treatments with energy-based devices.”
This information, he added, “will be very useful for further research studies because it forms the basis for formulating a set of core outcome measures to judge treatment interventions with consensus input from a variety of key opinion leaders. This will prove to be valuable because if we can have a uniform set of outcome measures to judge rosacea treatments with then we will be able to compare the results from different studies better.”
Ms. Ibrahim and colleagues reported having no relevant financial disclosures. Dr. Ibrahimi disclosed that he has been a speaker for both Candela and Cutera and he is currently on the medical advisory board for Cutera.
FROM ASLMS 2021
Pandemic experience taught lessons about clinician wellness
As a member of the Society of Hospital Medicine Wellbeing Task Force, Mark Rudolph, MD, SFHM, thought he understood a thing or two about resilience, but nothing could prepare him for the vulnerability he felt when his parents became infected with COVID-19 following a visit to New York City in March 2020 – which soon became an epicenter of disease outbreak.
“They were both quite ill but fortunately they recovered,” Dr. Rudolph, chief experience officer for Sound Physicians said during SHM Converge, the annual conference of the Society of Hospital Medicine. He had completed his residency training in New York, where he cared for patients following the 9/11 terrorist attacks, “so I had a lot of PTSD related to all that stuff,” he recalled. Then he started to worry about the clinicians who work for Sound Physicians, a multispecialty group with roots in hospital medicine. “I found it difficult knowing there was someone in the hospital somewhere taking care of our patients all day long, all night long,” he said. “I felt fearful for them.”
Other members of the SHM Wellbeing Task Force shared challenges they faced during the pandemic’s early stages, as well as lessons learned. Task force chair Sarah Richards, MD, said the COVID-19 pandemic brought on feelings of guilt after hearing from fellow hospitalists about the surge of cases they were caring for, or that their best friend or colleague died by suicide. “I felt a sense of guilt because I didn’t have a loved one get COVID or die from COVID,” said Dr. Richards, a hospitalist at the University of Nebraska Medical Center in Omaha. “I felt like the world was crumbling around me and I was still okay. That guilt was almost like a helplessness. I didn’t know how make it better. I didn’t know how to help people because the problem was so big, especially during the height of the pandemic. That was tough for me because I’m a helper. I think we go into this field wanting to help and I feel like we didn’t know how to help make things better.”
Sonia George, MD, recalled first hearing about COVID-19 as she was preparing to attend the 2020 SHM annual conference in San Diego, which was planned for April but was canceled amid the escalating health concerns. “That was difficult for me, because I wanted to travel more in 2020,” said Dr. George, a hospitalist at Long Island Jewish Medical Center in New Hyde Park, N.Y. “Traveling is something that I’ve been wanting to do ever since I finished residency, after all that training. I wanted to reward myself. What I have learned about myself is that I’ve learned to be more patient, to take every day as it is, to find some small moments of joy within each day and try to take that forward with me, and try to remember what I do have, and celebrate that a bit more every day.”
Over the past 14 months or so, Dr. Rudolph said that he grew to appreciate the importance of connecting with colleagues, “however short [the time] may be, where we can talk with one another, commiserate, discuss situations and experiences – whether virtually or in person. Those have been critical. If you add those all up, that’s what’s keeping us all going. At least it’s keeping me going.”
Dr. Richards echoed that sentiment. “The lesson I learned is that people really do want to share and to talk,” she said. “I can’t tell you how many times I told people about my [sense of] guilt and they would say things like, ‘Me, too!’ Knowing ‘it’s not just me’ made me feel so much better.”
During the course of the pandemic, the SHM Wellbeing Task Force created a one-page resource for clinicians known as the “Hospital Medicine COVID-19 Check-in Guide for Self & Peers,” which can be accessed here:. The three main recommended steps are to identify (“self-assess” to see if you are experiencing physical, emotional, cognitive, or behavioral stress); initiate (“reach out to your colleagues one-one-one or in small informal groups”); and intervene (“take action to make change or get help.”)
“Wellness and thriving are a team sport,” observed task force member Patrick Kneeland, MD, vice president of medical affairs at DispatchHealth, which provides hospital to home services. “It’s not an individual task to achieve. The team sport thing is complicated by gowns and masks and the lack of in-person meetings. You can’t even grab a cup of coffee with colleagues. That part has impacted most of us.” However, he said, he learned that clinicians can “double down on those small practices that form human connection” by using virtual communication platforms like Zoom. “For me, it’s been a great reminder [of] why presence with others matters, even if it’s in an unusual format, and how sharing our humanity across [communication] channels or through several layers of PPE is so critical.” Dr. Kneeland said.
None of the presenters reported having financial disclosures.
As a member of the Society of Hospital Medicine Wellbeing Task Force, Mark Rudolph, MD, SFHM, thought he understood a thing or two about resilience, but nothing could prepare him for the vulnerability he felt when his parents became infected with COVID-19 following a visit to New York City in March 2020 – which soon became an epicenter of disease outbreak.
“They were both quite ill but fortunately they recovered,” Dr. Rudolph, chief experience officer for Sound Physicians said during SHM Converge, the annual conference of the Society of Hospital Medicine. He had completed his residency training in New York, where he cared for patients following the 9/11 terrorist attacks, “so I had a lot of PTSD related to all that stuff,” he recalled. Then he started to worry about the clinicians who work for Sound Physicians, a multispecialty group with roots in hospital medicine. “I found it difficult knowing there was someone in the hospital somewhere taking care of our patients all day long, all night long,” he said. “I felt fearful for them.”
Other members of the SHM Wellbeing Task Force shared challenges they faced during the pandemic’s early stages, as well as lessons learned. Task force chair Sarah Richards, MD, said the COVID-19 pandemic brought on feelings of guilt after hearing from fellow hospitalists about the surge of cases they were caring for, or that their best friend or colleague died by suicide. “I felt a sense of guilt because I didn’t have a loved one get COVID or die from COVID,” said Dr. Richards, a hospitalist at the University of Nebraska Medical Center in Omaha. “I felt like the world was crumbling around me and I was still okay. That guilt was almost like a helplessness. I didn’t know how make it better. I didn’t know how to help people because the problem was so big, especially during the height of the pandemic. That was tough for me because I’m a helper. I think we go into this field wanting to help and I feel like we didn’t know how to help make things better.”
Sonia George, MD, recalled first hearing about COVID-19 as she was preparing to attend the 2020 SHM annual conference in San Diego, which was planned for April but was canceled amid the escalating health concerns. “That was difficult for me, because I wanted to travel more in 2020,” said Dr. George, a hospitalist at Long Island Jewish Medical Center in New Hyde Park, N.Y. “Traveling is something that I’ve been wanting to do ever since I finished residency, after all that training. I wanted to reward myself. What I have learned about myself is that I’ve learned to be more patient, to take every day as it is, to find some small moments of joy within each day and try to take that forward with me, and try to remember what I do have, and celebrate that a bit more every day.”
Over the past 14 months or so, Dr. Rudolph said that he grew to appreciate the importance of connecting with colleagues, “however short [the time] may be, where we can talk with one another, commiserate, discuss situations and experiences – whether virtually or in person. Those have been critical. If you add those all up, that’s what’s keeping us all going. At least it’s keeping me going.”
Dr. Richards echoed that sentiment. “The lesson I learned is that people really do want to share and to talk,” she said. “I can’t tell you how many times I told people about my [sense of] guilt and they would say things like, ‘Me, too!’ Knowing ‘it’s not just me’ made me feel so much better.”
During the course of the pandemic, the SHM Wellbeing Task Force created a one-page resource for clinicians known as the “Hospital Medicine COVID-19 Check-in Guide for Self & Peers,” which can be accessed here:. The three main recommended steps are to identify (“self-assess” to see if you are experiencing physical, emotional, cognitive, or behavioral stress); initiate (“reach out to your colleagues one-one-one or in small informal groups”); and intervene (“take action to make change or get help.”)
“Wellness and thriving are a team sport,” observed task force member Patrick Kneeland, MD, vice president of medical affairs at DispatchHealth, which provides hospital to home services. “It’s not an individual task to achieve. The team sport thing is complicated by gowns and masks and the lack of in-person meetings. You can’t even grab a cup of coffee with colleagues. That part has impacted most of us.” However, he said, he learned that clinicians can “double down on those small practices that form human connection” by using virtual communication platforms like Zoom. “For me, it’s been a great reminder [of] why presence with others matters, even if it’s in an unusual format, and how sharing our humanity across [communication] channels or through several layers of PPE is so critical.” Dr. Kneeland said.
None of the presenters reported having financial disclosures.
As a member of the Society of Hospital Medicine Wellbeing Task Force, Mark Rudolph, MD, SFHM, thought he understood a thing or two about resilience, but nothing could prepare him for the vulnerability he felt when his parents became infected with COVID-19 following a visit to New York City in March 2020 – which soon became an epicenter of disease outbreak.
“They were both quite ill but fortunately they recovered,” Dr. Rudolph, chief experience officer for Sound Physicians said during SHM Converge, the annual conference of the Society of Hospital Medicine. He had completed his residency training in New York, where he cared for patients following the 9/11 terrorist attacks, “so I had a lot of PTSD related to all that stuff,” he recalled. Then he started to worry about the clinicians who work for Sound Physicians, a multispecialty group with roots in hospital medicine. “I found it difficult knowing there was someone in the hospital somewhere taking care of our patients all day long, all night long,” he said. “I felt fearful for them.”
Other members of the SHM Wellbeing Task Force shared challenges they faced during the pandemic’s early stages, as well as lessons learned. Task force chair Sarah Richards, MD, said the COVID-19 pandemic brought on feelings of guilt after hearing from fellow hospitalists about the surge of cases they were caring for, or that their best friend or colleague died by suicide. “I felt a sense of guilt because I didn’t have a loved one get COVID or die from COVID,” said Dr. Richards, a hospitalist at the University of Nebraska Medical Center in Omaha. “I felt like the world was crumbling around me and I was still okay. That guilt was almost like a helplessness. I didn’t know how make it better. I didn’t know how to help people because the problem was so big, especially during the height of the pandemic. That was tough for me because I’m a helper. I think we go into this field wanting to help and I feel like we didn’t know how to help make things better.”
Sonia George, MD, recalled first hearing about COVID-19 as she was preparing to attend the 2020 SHM annual conference in San Diego, which was planned for April but was canceled amid the escalating health concerns. “That was difficult for me, because I wanted to travel more in 2020,” said Dr. George, a hospitalist at Long Island Jewish Medical Center in New Hyde Park, N.Y. “Traveling is something that I’ve been wanting to do ever since I finished residency, after all that training. I wanted to reward myself. What I have learned about myself is that I’ve learned to be more patient, to take every day as it is, to find some small moments of joy within each day and try to take that forward with me, and try to remember what I do have, and celebrate that a bit more every day.”
Over the past 14 months or so, Dr. Rudolph said that he grew to appreciate the importance of connecting with colleagues, “however short [the time] may be, where we can talk with one another, commiserate, discuss situations and experiences – whether virtually or in person. Those have been critical. If you add those all up, that’s what’s keeping us all going. At least it’s keeping me going.”
Dr. Richards echoed that sentiment. “The lesson I learned is that people really do want to share and to talk,” she said. “I can’t tell you how many times I told people about my [sense of] guilt and they would say things like, ‘Me, too!’ Knowing ‘it’s not just me’ made me feel so much better.”
During the course of the pandemic, the SHM Wellbeing Task Force created a one-page resource for clinicians known as the “Hospital Medicine COVID-19 Check-in Guide for Self & Peers,” which can be accessed here:. The three main recommended steps are to identify (“self-assess” to see if you are experiencing physical, emotional, cognitive, or behavioral stress); initiate (“reach out to your colleagues one-one-one or in small informal groups”); and intervene (“take action to make change or get help.”)
“Wellness and thriving are a team sport,” observed task force member Patrick Kneeland, MD, vice president of medical affairs at DispatchHealth, which provides hospital to home services. “It’s not an individual task to achieve. The team sport thing is complicated by gowns and masks and the lack of in-person meetings. You can’t even grab a cup of coffee with colleagues. That part has impacted most of us.” However, he said, he learned that clinicians can “double down on those small practices that form human connection” by using virtual communication platforms like Zoom. “For me, it’s been a great reminder [of] why presence with others matters, even if it’s in an unusual format, and how sharing our humanity across [communication] channels or through several layers of PPE is so critical.” Dr. Kneeland said.
None of the presenters reported having financial disclosures.
FROM SHM CONVERGE 2021
One treatment with a 1,060-nm diode laser helped reduce unwanted fat
A a small single-center study showed.
Nonsurgical fat reduction was the third-most common nonsurgical aesthetic procedure in the United States in 2018 and includes lasers, high-intensity focused ultrasound, radiofrequency, photobiomodulation therapy, and cryolipolysis, according to 2018 data from the American Society for Aesthetic Plastic Surgery.
“Our study is unique because we used a 1,060-nm diode laser with integrated skin cooling to evaluate the efficacy and safety of its use for the reduction of unwanted fat of the abdomen and flanks,” lead study author Alison S. Kang, MD, told this news organization following the annual conference of the American Society for Laser Medicine and Surgery, where the data were presented. “A 1,060-nm laser works by delivering controlled thermal energy between 42 °C and 47 °C, temperatures at which adipocytes are permanently destroyed,” she explained.
Dr. Kang and Suzanne Kilmer, MD, both of the Laser & Skin Surgery Center of Northern California, Sacramento, enrolled 28 women and 2 men into the study. Each study participant received a single treatment with Venus Bliss, a 1,060-nm diode laser with four laser applicators and a built-in skin-cooling mechanism. Half received treatment of the flanks delivered at up to 1.4 watts per cm2 on each diode for 25 minutes, while the other 15 received treatment of the abdomen with the same energy settings. Photos and ultrasound images were taken at baseline, 6 weeks, and 12 weeks, and the investigators administered a satisfaction questionnaire upon study exit. The primary endpoint was efficacy, defined as the percentage of correctly identified posttreatment photographs by three blinded reviewers (one plastic surgeon and two dermatologists). Secondary endpoints of interest were change in adipose thickness on ultrasound, subject satisfaction, and adverse events.
After losing 1 patient to follow-up, 29 completed the study. Dr. Kang reported that the blinded evaluators could identify the pretreatment image, compared with the posttreatment image in an average of 67% of patients. Between baseline and 12 weeks, the ultrasound images showed an average reduction in the adipose layer of 9% on the abdomen and 7% on the flank, while the average self-reported pain score based on the Wong-Baker FACES Pain Rating Scale was 2 out of 10 among those in the abdomen treatment group and 2.6 out of 10 among those in the flank treatment group.
In addition, 76% of subjects stated they were “satisfied” to “very satisfied” with the treatment, and 79% stated that they would recommend this treatment to a friend. The most common posttreatment responses in both groups were erythema and trace edema, but no serious or permanent adverse events were observed.
Dr. Kang acknowledged certain limitations of the study, including its small sample size. “Only one treatment was performed in our study, so it is unclear if multiple treatments will improve efficacy or if multiple treatments will have no effect on efficacy,” she said.
The work won a “best of session early career-clinical” abstract award from the ASLMS.
The study was funded by Venus Concept, the manufacturer of the Venus Bliss laser. Dr. Kang reported having no relevant financial disclosures. Dr. Kilmer has received grants and honoraria from Venus Concept.
[email protected]
A a small single-center study showed.
Nonsurgical fat reduction was the third-most common nonsurgical aesthetic procedure in the United States in 2018 and includes lasers, high-intensity focused ultrasound, radiofrequency, photobiomodulation therapy, and cryolipolysis, according to 2018 data from the American Society for Aesthetic Plastic Surgery.
“Our study is unique because we used a 1,060-nm diode laser with integrated skin cooling to evaluate the efficacy and safety of its use for the reduction of unwanted fat of the abdomen and flanks,” lead study author Alison S. Kang, MD, told this news organization following the annual conference of the American Society for Laser Medicine and Surgery, where the data were presented. “A 1,060-nm laser works by delivering controlled thermal energy between 42 °C and 47 °C, temperatures at which adipocytes are permanently destroyed,” she explained.
Dr. Kang and Suzanne Kilmer, MD, both of the Laser & Skin Surgery Center of Northern California, Sacramento, enrolled 28 women and 2 men into the study. Each study participant received a single treatment with Venus Bliss, a 1,060-nm diode laser with four laser applicators and a built-in skin-cooling mechanism. Half received treatment of the flanks delivered at up to 1.4 watts per cm2 on each diode for 25 minutes, while the other 15 received treatment of the abdomen with the same energy settings. Photos and ultrasound images were taken at baseline, 6 weeks, and 12 weeks, and the investigators administered a satisfaction questionnaire upon study exit. The primary endpoint was efficacy, defined as the percentage of correctly identified posttreatment photographs by three blinded reviewers (one plastic surgeon and two dermatologists). Secondary endpoints of interest were change in adipose thickness on ultrasound, subject satisfaction, and adverse events.
After losing 1 patient to follow-up, 29 completed the study. Dr. Kang reported that the blinded evaluators could identify the pretreatment image, compared with the posttreatment image in an average of 67% of patients. Between baseline and 12 weeks, the ultrasound images showed an average reduction in the adipose layer of 9% on the abdomen and 7% on the flank, while the average self-reported pain score based on the Wong-Baker FACES Pain Rating Scale was 2 out of 10 among those in the abdomen treatment group and 2.6 out of 10 among those in the flank treatment group.
In addition, 76% of subjects stated they were “satisfied” to “very satisfied” with the treatment, and 79% stated that they would recommend this treatment to a friend. The most common posttreatment responses in both groups were erythema and trace edema, but no serious or permanent adverse events were observed.
Dr. Kang acknowledged certain limitations of the study, including its small sample size. “Only one treatment was performed in our study, so it is unclear if multiple treatments will improve efficacy or if multiple treatments will have no effect on efficacy,” she said.
The work won a “best of session early career-clinical” abstract award from the ASLMS.
The study was funded by Venus Concept, the manufacturer of the Venus Bliss laser. Dr. Kang reported having no relevant financial disclosures. Dr. Kilmer has received grants and honoraria from Venus Concept.
[email protected]
A a small single-center study showed.
Nonsurgical fat reduction was the third-most common nonsurgical aesthetic procedure in the United States in 2018 and includes lasers, high-intensity focused ultrasound, radiofrequency, photobiomodulation therapy, and cryolipolysis, according to 2018 data from the American Society for Aesthetic Plastic Surgery.
“Our study is unique because we used a 1,060-nm diode laser with integrated skin cooling to evaluate the efficacy and safety of its use for the reduction of unwanted fat of the abdomen and flanks,” lead study author Alison S. Kang, MD, told this news organization following the annual conference of the American Society for Laser Medicine and Surgery, where the data were presented. “A 1,060-nm laser works by delivering controlled thermal energy between 42 °C and 47 °C, temperatures at which adipocytes are permanently destroyed,” she explained.
Dr. Kang and Suzanne Kilmer, MD, both of the Laser & Skin Surgery Center of Northern California, Sacramento, enrolled 28 women and 2 men into the study. Each study participant received a single treatment with Venus Bliss, a 1,060-nm diode laser with four laser applicators and a built-in skin-cooling mechanism. Half received treatment of the flanks delivered at up to 1.4 watts per cm2 on each diode for 25 minutes, while the other 15 received treatment of the abdomen with the same energy settings. Photos and ultrasound images were taken at baseline, 6 weeks, and 12 weeks, and the investigators administered a satisfaction questionnaire upon study exit. The primary endpoint was efficacy, defined as the percentage of correctly identified posttreatment photographs by three blinded reviewers (one plastic surgeon and two dermatologists). Secondary endpoints of interest were change in adipose thickness on ultrasound, subject satisfaction, and adverse events.
After losing 1 patient to follow-up, 29 completed the study. Dr. Kang reported that the blinded evaluators could identify the pretreatment image, compared with the posttreatment image in an average of 67% of patients. Between baseline and 12 weeks, the ultrasound images showed an average reduction in the adipose layer of 9% on the abdomen and 7% on the flank, while the average self-reported pain score based on the Wong-Baker FACES Pain Rating Scale was 2 out of 10 among those in the abdomen treatment group and 2.6 out of 10 among those in the flank treatment group.
In addition, 76% of subjects stated they were “satisfied” to “very satisfied” with the treatment, and 79% stated that they would recommend this treatment to a friend. The most common posttreatment responses in both groups were erythema and trace edema, but no serious or permanent adverse events were observed.
Dr. Kang acknowledged certain limitations of the study, including its small sample size. “Only one treatment was performed in our study, so it is unclear if multiple treatments will improve efficacy or if multiple treatments will have no effect on efficacy,” she said.
The work won a “best of session early career-clinical” abstract award from the ASLMS.
The study was funded by Venus Concept, the manufacturer of the Venus Bliss laser. Dr. Kang reported having no relevant financial disclosures. Dr. Kilmer has received grants and honoraria from Venus Concept.
[email protected]
FROM ASLMS 2021
Combined imaging methods found to enhance detection of squamous cell carcinoma
and distinguishing SCC in-situ and actinic keratosis (AK) from invasive SCC, results from a small prospective study demonstrated.
“A solitary scaly papule or plaque could represent an inflammatory or neoplastic process, and when neoplastic, it could be benign, premalignant, malignant in situ, or invasive malignant,” lead study author Abdullah Aleisa, MD, said in an interview during the annual conference of the American Society for Laser Medicine and Surgery. Noninvasive imaging devices, such as reflectance confocal microscopy (RCM) and optical coherence tomography (OCT), “have been used to help in the diagnosis of those clinically suspicious lesions, however each device has its own limitation.”
RCM images are horizontal sections of the skin with high cellular resolution but limited to 250 mcm of depth in skin, he said, while OCT images are vertical sections of the skin with low cellular resolution, but image up to 1,000-2,000 mcm of depth in skin.
“Combined RCM-OCT enables high cellular resolution and deep tissue evaluation,” said Dr. Aleisa, a micrographic surgery and dermatologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York. “The value of combined RCM-OCT has been shown in the detection and depth assessment of basal cell carcinoma, but it has never been studied in SCC. Our objective is to combine RCM and OCT simultaneously to detect SCC and assess the depth of invasion.”
Between September and December 2020, Dr. Aleisa and colleagues prospectively imaged 36 lesions suspicious of SCC, SCC in situ, or AK between September 2020 and December 2020. The mean age of the cohort was 68 years and 63% were male. Using a prototype device from Andover, Mass.–based Caliber I.D., the investigators performed handheld RCM-OCT imaging at the center of clinically suspected lesions before biopsy and to previously diagnosed lesions before Mohs micrographic surgery (to check for residual tumor) and correlated RCM-OCT findings with histopathology results. A total of 36 lesions were treated.
Dr. Aleisa reported that most common RCM-OCT feature for invasive SCC was presence of vertical blood vessels (in 89% of lesions), while for SCC in situ/AK, it was acanthosis and parakeratosis without vertical blood vessels (in 84% of lesions). For the detection of invasive SCC, RCM-OCT had a sensitivity of 82%, a specificity of 92%, a negative predictive value of 92%, and a positive predictive value of 82%. For the detection of SCC in situ/AK, RCM-OCT had a sensitivity of 86%, a specificity of 100%, a negative predictive value of 92%, and a positive predictive value of 100%. The OCT depth measurement correlated well with histopathology with a concordance correlation coefficient of r2 = 0.9.
“Using RCM’s high-resolution pictures allowed us to easily spot the vertical ‘buttonhole’ vessels associated with SCC,” Dr. Aleisa said. “However, given the depth limitation of RCM, the distinction between SCC in situ and invasive SCC could not be accomplished using RCM alone. Therefore, having simultaneous OCT live feedback to the RCM images in the combined RCM-OCT device enabled us to assess the depth of those vertical ‘buttonholes’ and distinguish between SCC in situ and invasive SCC.”
He acknowledged certain limitations of the approach, including that it requires approximately 20 minutes per imaging session, there is a steep learning curve for interpreting images, and certain anatomical sites are challenging to image, especially the nose, periocular area, and lip.
The study won a “best of session” emerging technologies abstract award from the ASLMS.
Milind Rajadhyaksha, PhD, of Memorial Sloan Kettering Cancer Center helped to develop the prototype device. Dr. Aleisa reported having no relevant financial disclosures.
and distinguishing SCC in-situ and actinic keratosis (AK) from invasive SCC, results from a small prospective study demonstrated.
“A solitary scaly papule or plaque could represent an inflammatory or neoplastic process, and when neoplastic, it could be benign, premalignant, malignant in situ, or invasive malignant,” lead study author Abdullah Aleisa, MD, said in an interview during the annual conference of the American Society for Laser Medicine and Surgery. Noninvasive imaging devices, such as reflectance confocal microscopy (RCM) and optical coherence tomography (OCT), “have been used to help in the diagnosis of those clinically suspicious lesions, however each device has its own limitation.”
RCM images are horizontal sections of the skin with high cellular resolution but limited to 250 mcm of depth in skin, he said, while OCT images are vertical sections of the skin with low cellular resolution, but image up to 1,000-2,000 mcm of depth in skin.
“Combined RCM-OCT enables high cellular resolution and deep tissue evaluation,” said Dr. Aleisa, a micrographic surgery and dermatologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York. “The value of combined RCM-OCT has been shown in the detection and depth assessment of basal cell carcinoma, but it has never been studied in SCC. Our objective is to combine RCM and OCT simultaneously to detect SCC and assess the depth of invasion.”
Between September and December 2020, Dr. Aleisa and colleagues prospectively imaged 36 lesions suspicious of SCC, SCC in situ, or AK between September 2020 and December 2020. The mean age of the cohort was 68 years and 63% were male. Using a prototype device from Andover, Mass.–based Caliber I.D., the investigators performed handheld RCM-OCT imaging at the center of clinically suspected lesions before biopsy and to previously diagnosed lesions before Mohs micrographic surgery (to check for residual tumor) and correlated RCM-OCT findings with histopathology results. A total of 36 lesions were treated.
Dr. Aleisa reported that most common RCM-OCT feature for invasive SCC was presence of vertical blood vessels (in 89% of lesions), while for SCC in situ/AK, it was acanthosis and parakeratosis without vertical blood vessels (in 84% of lesions). For the detection of invasive SCC, RCM-OCT had a sensitivity of 82%, a specificity of 92%, a negative predictive value of 92%, and a positive predictive value of 82%. For the detection of SCC in situ/AK, RCM-OCT had a sensitivity of 86%, a specificity of 100%, a negative predictive value of 92%, and a positive predictive value of 100%. The OCT depth measurement correlated well with histopathology with a concordance correlation coefficient of r2 = 0.9.
“Using RCM’s high-resolution pictures allowed us to easily spot the vertical ‘buttonhole’ vessels associated with SCC,” Dr. Aleisa said. “However, given the depth limitation of RCM, the distinction between SCC in situ and invasive SCC could not be accomplished using RCM alone. Therefore, having simultaneous OCT live feedback to the RCM images in the combined RCM-OCT device enabled us to assess the depth of those vertical ‘buttonholes’ and distinguish between SCC in situ and invasive SCC.”
He acknowledged certain limitations of the approach, including that it requires approximately 20 minutes per imaging session, there is a steep learning curve for interpreting images, and certain anatomical sites are challenging to image, especially the nose, periocular area, and lip.
The study won a “best of session” emerging technologies abstract award from the ASLMS.
Milind Rajadhyaksha, PhD, of Memorial Sloan Kettering Cancer Center helped to develop the prototype device. Dr. Aleisa reported having no relevant financial disclosures.
and distinguishing SCC in-situ and actinic keratosis (AK) from invasive SCC, results from a small prospective study demonstrated.
“A solitary scaly papule or plaque could represent an inflammatory or neoplastic process, and when neoplastic, it could be benign, premalignant, malignant in situ, or invasive malignant,” lead study author Abdullah Aleisa, MD, said in an interview during the annual conference of the American Society for Laser Medicine and Surgery. Noninvasive imaging devices, such as reflectance confocal microscopy (RCM) and optical coherence tomography (OCT), “have been used to help in the diagnosis of those clinically suspicious lesions, however each device has its own limitation.”
RCM images are horizontal sections of the skin with high cellular resolution but limited to 250 mcm of depth in skin, he said, while OCT images are vertical sections of the skin with low cellular resolution, but image up to 1,000-2,000 mcm of depth in skin.
“Combined RCM-OCT enables high cellular resolution and deep tissue evaluation,” said Dr. Aleisa, a micrographic surgery and dermatologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York. “The value of combined RCM-OCT has been shown in the detection and depth assessment of basal cell carcinoma, but it has never been studied in SCC. Our objective is to combine RCM and OCT simultaneously to detect SCC and assess the depth of invasion.”
Between September and December 2020, Dr. Aleisa and colleagues prospectively imaged 36 lesions suspicious of SCC, SCC in situ, or AK between September 2020 and December 2020. The mean age of the cohort was 68 years and 63% were male. Using a prototype device from Andover, Mass.–based Caliber I.D., the investigators performed handheld RCM-OCT imaging at the center of clinically suspected lesions before biopsy and to previously diagnosed lesions before Mohs micrographic surgery (to check for residual tumor) and correlated RCM-OCT findings with histopathology results. A total of 36 lesions were treated.
Dr. Aleisa reported that most common RCM-OCT feature for invasive SCC was presence of vertical blood vessels (in 89% of lesions), while for SCC in situ/AK, it was acanthosis and parakeratosis without vertical blood vessels (in 84% of lesions). For the detection of invasive SCC, RCM-OCT had a sensitivity of 82%, a specificity of 92%, a negative predictive value of 92%, and a positive predictive value of 82%. For the detection of SCC in situ/AK, RCM-OCT had a sensitivity of 86%, a specificity of 100%, a negative predictive value of 92%, and a positive predictive value of 100%. The OCT depth measurement correlated well with histopathology with a concordance correlation coefficient of r2 = 0.9.
“Using RCM’s high-resolution pictures allowed us to easily spot the vertical ‘buttonhole’ vessels associated with SCC,” Dr. Aleisa said. “However, given the depth limitation of RCM, the distinction between SCC in situ and invasive SCC could not be accomplished using RCM alone. Therefore, having simultaneous OCT live feedback to the RCM images in the combined RCM-OCT device enabled us to assess the depth of those vertical ‘buttonholes’ and distinguish between SCC in situ and invasive SCC.”
He acknowledged certain limitations of the approach, including that it requires approximately 20 minutes per imaging session, there is a steep learning curve for interpreting images, and certain anatomical sites are challenging to image, especially the nose, periocular area, and lip.
The study won a “best of session” emerging technologies abstract award from the ASLMS.
Milind Rajadhyaksha, PhD, of Memorial Sloan Kettering Cancer Center helped to develop the prototype device. Dr. Aleisa reported having no relevant financial disclosures.
FROM ASLMS 2021