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Efficacy of a multimodal brightening regimen in Asian subjects with moderate to severe facial hyperpigmentation
903
1375
Efficacy of a multimodal brightening regimen in Asian subjects with moderate to severe facial hyperpigmentation Makino Elizabeth, MBA, SkinMedica, an Allergan Company, Carlsbad, CA, United States; Rahul Mehta, PhD, SkinMedica, an Allergan Company, Carlsbad, CA, United States
Epidemiology survey of eyelash characteristics in Chinese adult women in China’s urban cities Jiangli Di, MD, PhD, National Center for Women and Children’s Health, China CDC, Beijing, China; Linhong Wang, MD, National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC, Beijing, China; Gengli Zhao, MD, Peking University First Hospital, Beijing, China; Yinghui Liu, MD, PhD, Quintiles Enterprise Management (Shanghai) Co, Ltd, Beijing, China; Bin Cai, MD, PhD, Allergan, Inc, Bridgewater, NJ, United States Objective: To estimate the prevalence of upper eyelash hypotrichosis in a representative cohort of Chinese adult females as measured by a grade of 1 or 2 using the Global Eyelash Assessment (GEA) scale with Asian Photonumeric Guide and to describe subjects’ self-rated satisfaction with their eyelashes. Methods: A cross-sectional survey of 1603 adult females selected via 2-stage cluster sampling method from 5 urban Chinese cities (Beijing, Hangzhou, Guangzhou, Chongqing, and Changsha) was conducted to assess upper eyelash prominence using the validated GEA scale and to record subjects’ satisfaction with their eyelashes. The GEA uses a clinician-graded, static, ordinal, 4-point scale (1 ¼ minimal, 2 ¼ moderate, 3 ¼ marked, and 4 ¼ very marked) with an accompanying guide that contains photographic examples of Asian subjects representative of each GEA grade. Eyelash hypotrichosis was defined a priori as GEA grade of 1 or 2. Subjects’ satisfaction with their upper eyelash characteristics (length and fullness/thickness) was collected from a self-completed subject questionnaire.
Hyperpigmentation disorders in skin of color can be especially challenging to treat due to differences in intrinsic features including melanocyte activity levels, melanosome size, density and degradation once dispersed in the stratum corneum. Due to these differences, the efficacy of hyperpigmentation treatments should be assessed in a variety of ethnicities. To assess the efficacy and tolerability of a multimodal skin brightening regimen in ethnic skin, a 12-week, single-center, openlabel study was conducted specifically in subjects with skin of color and moderate to severe facial hyperpigmentation. Thirty-three Thai female subjects aged 19-58 years with Fitzpatrick skin types IV and V were enrolled into the study. Subjects presented with moderate to severe facial hyperpigmentation as assessed by a score of 4-9 on an overall hyperpigmentation scale (0-9). Subjects were instructed to apply a skin brightening complex onto their facial skin, twice daily after cleansing, for 12 weeks. Subjects also applied a nonprescription retinol product, moisturizer, and sunscreen. At baseline and weeks 4, 8, and 12, subjects were assessed for overall hyperpigmentation, blotch appearance (including color: light to dark, size: small to large, occurrence: slightly visible to highly visible, number: minimal to numerous, and homogeneity: very uneven to homogeneous) on a 10-point scale. Standardized digital photographs were also taken of the subjects’ facial skin at all visits. Subjects completed a self-assessment questionnaire at all follow-up visits. Thirty subjects completed the study with three of the subjects lost to follow-up. Statistically significant reductions in mean scores for overall hyperpigmentation, blotch color and blotch size were observed at week 4 with continued significant reductions through week 12 (all P ¼ .04). At week 12, significant reductions in the number, homogeneity and occurrence were also observed. The regimen was consistently highly rated by subjects at all follow-up visits with 97% and above noticing that the regimen ‘‘decreased the appearance of uneven skin tone and discolorations’’ and ‘‘improved the overall condition’’ of their skin. Standardized photography also showed the improvements observed by both the investigator and subjects. These study results support the efficacy and tolerability of this multimodality skin brightening regimen in skin of color. 100% sponsored by SkinMedica, an Allergan Company.
Results: The overall prevalence of eyelash hypotrichosis in surveyed subjects was 83.1% (695% confidence interval: 81.3-84.9%). The prevalence increased with age, from 69.7% in the 18-24 years age group, to 84.6% in the 35-39 years age group, and 97.2% in the ¼60 years age group. Subject-reported eyelash satisfaction showed that 19.8% of subjects were unsatisfied or very unsatisfied with their eyelash length; similarly, 19.8% were unsatisfied or very unsatisfied with their eyelash fullness/thickness. Overall eyelash satisfaction results showed that 16.7% of subjects were unsatisfied or very unsatisfied with their eyelashes. However, the majority of surveyed subjects (82.5%) were interested in improving their eyelash appearance; 39.4% of subjects \ 50 years were extremely or very interested in improving their eyelash appearance compared to 19.4% of subjects ¼50 years. Additionally, 43.3% of subjects were somewhat or very interested in a safe and effective prescription product to increase the prominence of their eyelashes. Conclusion: More than 83% of adult Chinese female subjects in China exhibit eyelash hypotrichosis. Approximately 17% of subjects were not satisfied with their eyelashes; however, more than 82% were interested in improving their eyelash appearance and more than 43% were interested in a safe and effective prescription product to increase the prominence of their eyelashes. Sponsored by Allergan, Inc, Irvine, CA. Editorial assistance was provided to the authors by Peloton Advantage, Parsippany, NJ and was funded by Allergan, Inc.
1284 Efficacy of ATX-101 for reducing submental fullness associated with submental fat in demographic subgroups of subjects from the US/CAN phase 3 trials, REFINE-1 and REFINE-2 Frederic Brandt, Dermatology Research Institute, LLC, Coral Gables, FL, United States; Corey Maas, Maas Clinic, San Francisco, CA, United States; Paul Lizzul, Kythera Biopharmaceuticals, Westlake Village, CA, United States; Todd Gross, Kythera Biopharmaceuticals, Westlake Village, CA, United States; Frederick Beddingfield, Kythera Biopharmaceuticals, Westlake Village, CA, United States Background: Submental fat (SMF) may present as an unappealing fullness that can negatively affect well-being. ATX-101 is a formulation of pure synthetic deoxycholic acid that causes focal adipocytolysis and has been extensively studied for SMF reduction. This abstract reports efficacy in subgroups of subjects enrolled in the US/CAN phase 3 trials.
1819
Design: In 2 randomized double-blind placebo-controlled trials, REFINE-1 and REFINE-2, subjects with SMF graded moderate or severe by the investigator and by the subject using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported (PR)-SMFRS, respectively, were treated with ATX-101 2 mg/cm2 (area-adjusted) or placebo. The co-primary endpoints were $1-grade improvement from baseline at 12 weeks in composite CR-SMFRS/PR-SMFRS and $2-grade improvement in the composite endpoint. ATX-101 was compared to placebo within 18 subgroups, based on 9 demographic variables (age, sex, race, ethnicity, Fitzpatrick skin type, body mass index (BMI), baseline SMF severity [CR and PR] and baseline skin laxity). Also, $1-grade CR-SMFRS response rates (CR-1) were compared for the 2 demographic subgroups for each variable (eg sex: males vs females). Results: Both coprimary endpoints were met in each study. A pooled analysis of all 1022 randomized subjects (from both studies) showed that 82% of ATX-101 subjects achieved a CR-1 response, compared with 35% of placebo subjects (P \.001). A significant treatment effect of ATX-101 was observed within all 18 subgroups. In ATX-101 subjects, CR-1 response was high in all subgroups ($75%) and $80% in 14 subgroups. When two subgroups of the same demographic were compared, the difference in CR-1 response between the subgroups within the ATX-101 treatment group was not clinically meaningful and ranged from 0.3% (skin laxity) to 8.1% (race), indicating minimal difference in CR-1 responder rates as a function of subject characteristics. In addition, a multivariate logistic regression model predicting responder rates for CR-1 from the 9 demographic variables indicated no effect of 7 of the variables on treatment response, and only slightly higher response rates (not clinically meaningful) for subjects with higher baseline SMF severity (84.3% vs 79.6%, P ¼ .002) and lower BMI (83.8% vs 79.1%, P ¼ .043). Conclusion: These results confirm that ATX-101 is efficacious in reducing SMF and improving submental contour regardless of subject characteristics at baseline.
Evaluation of Merz hand grading scale following calcium hydroxylapatite hand treatment Vince Bertucci, MD, University of Toronto, Toronto, Ontario, Canada; Nowell Solish, MD, University of Toronto, private practice, Toronto, Ontario, Canada Calcium hydroxylapatite (CaHA) is approved for the treatment of hands in Canada. The Merz hand grading scale (MHGS) is used to grade appearance of the dorsal hand on a 5-point scale (0 ¼ no loss of fatty tissue; 4 ¼ very severe loss of fatty tissue; marked visibility of veins and tendons). The MHGS has been previously validated for photographic assessment of the hands. A recent live validation study has demonstrated that the MHGS is suitable for live assessment in clinical studies. The primary objective of this study was to assess the sensitivity of the validated MHGS to detect changes in hand appearance 1 month after CaHA hand treatment. In this randomized, controlled, single-blind study, 41 subjects were screened at 2 investigational sites. Thirty (30) subjects with a live rating of 2 or 3 on the MHGS were enrolled and randomized: 20 subjects to a treatment group and 10 subjects to an untreated control group. Subjects randomized to the treatment group received treatment at enrollment and subjects randomized to the control group received treatment at week 4 after completion of MHGS ratings. CaHA was mixed with lidocaine according to the Canadian Instructions for Use. Subjects received treatment in the dorsum of each hand. The MHGS ratings were made from live assessment of subject hands performed by a qualified and blinded evaluator at baseline, week 2 and 4 visits. Safety was assessed by recording all AEs occurring after hand treatment to the week 4 visit. Effectiveness was also measured using the Global Aesthetic Improvement Scale (GAIS), as well as physician and subject satisfaction questionnaires. All 30 enrolled subjects completed the study. The majority of subjects were female (93.3%) and Caucasian (90.0%) with a mean age of 51.5 years. A significant improvement in MHGS ratings was demonstrated in the Immediate Treatment Group compared to baseline [(0.4 vs 2.5), (0.7 vs 2.5); P \.0001] and to the control [(-2.1 vs -0.1), (-1.8 vs 0.0); P \.0001] at weeks 2 and 4, respectively]. All (100%) subjects in the treatment group had ¼1 point improvement in both hands (P \ .0001). The AEs reported in this study were expected, generally short in duration, and typical of dermal filler injections. Swelling was the most frequently reported AE. The results of this study demonstrate that the MHGS is effective in detecting clinically meaningful effects in the dorsum of hands after treatment with calcium hydroxylapatite.
This study is Sponsored by Kythera Pharmaceuticals.
100% is Sponsored by Merz North America, Inc.
MAY 2015
J AM ACAD DERMATOL
AB17
1375
Efficacy of a multimodal brightening regimen in Asian subjects with moderate to severe facial hyperpigmentation Makino Elizabeth, MBA, SkinMedica, an Allergan Company, Carlsbad, CA, United States; Rahul Mehta, PhD, SkinMedica, an Allergan Company, Carlsbad, CA, United States
Epidemiology survey of eyelash characteristics in Chinese adult women in China’s urban cities Jiangli Di, MD, PhD, National Center for Women and Children’s Health, China CDC, Beijing, China; Linhong Wang, MD, National Center for Chronic and Noncommunicable Disease Control and Prevention, China CDC, Beijing, China; Gengli Zhao, MD, Peking University First Hospital, Beijing, China; Yinghui Liu, MD, PhD, Quintiles Enterprise Management (Shanghai) Co, Ltd, Beijing, China; Bin Cai, MD, PhD, Allergan, Inc, Bridgewater, NJ, United States Objective: To estimate the prevalence of upper eyelash hypotrichosis in a representative cohort of Chinese adult females as measured by a grade of 1 or 2 using the Global Eyelash Assessment (GEA) scale with Asian Photonumeric Guide and to describe subjects’ self-rated satisfaction with their eyelashes. Methods: A cross-sectional survey of 1603 adult females selected via 2-stage cluster sampling method from 5 urban Chinese cities (Beijing, Hangzhou, Guangzhou, Chongqing, and Changsha) was conducted to assess upper eyelash prominence using the validated GEA scale and to record subjects’ satisfaction with their eyelashes. The GEA uses a clinician-graded, static, ordinal, 4-point scale (1 ¼ minimal, 2 ¼ moderate, 3 ¼ marked, and 4 ¼ very marked) with an accompanying guide that contains photographic examples of Asian subjects representative of each GEA grade. Eyelash hypotrichosis was defined a priori as GEA grade of 1 or 2. Subjects’ satisfaction with their upper eyelash characteristics (length and fullness/thickness) was collected from a self-completed subject questionnaire.
Hyperpigmentation disorders in skin of color can be especially challenging to treat due to differences in intrinsic features including melanocyte activity levels, melanosome size, density and degradation once dispersed in the stratum corneum. Due to these differences, the efficacy of hyperpigmentation treatments should be assessed in a variety of ethnicities. To assess the efficacy and tolerability of a multimodal skin brightening regimen in ethnic skin, a 12-week, single-center, openlabel study was conducted specifically in subjects with skin of color and moderate to severe facial hyperpigmentation. Thirty-three Thai female subjects aged 19-58 years with Fitzpatrick skin types IV and V were enrolled into the study. Subjects presented with moderate to severe facial hyperpigmentation as assessed by a score of 4-9 on an overall hyperpigmentation scale (0-9). Subjects were instructed to apply a skin brightening complex onto their facial skin, twice daily after cleansing, for 12 weeks. Subjects also applied a nonprescription retinol product, moisturizer, and sunscreen. At baseline and weeks 4, 8, and 12, subjects were assessed for overall hyperpigmentation, blotch appearance (including color: light to dark, size: small to large, occurrence: slightly visible to highly visible, number: minimal to numerous, and homogeneity: very uneven to homogeneous) on a 10-point scale. Standardized digital photographs were also taken of the subjects’ facial skin at all visits. Subjects completed a self-assessment questionnaire at all follow-up visits. Thirty subjects completed the study with three of the subjects lost to follow-up. Statistically significant reductions in mean scores for overall hyperpigmentation, blotch color and blotch size were observed at week 4 with continued significant reductions through week 12 (all P ¼ .04). At week 12, significant reductions in the number, homogeneity and occurrence were also observed. The regimen was consistently highly rated by subjects at all follow-up visits with 97% and above noticing that the regimen ‘‘decreased the appearance of uneven skin tone and discolorations’’ and ‘‘improved the overall condition’’ of their skin. Standardized photography also showed the improvements observed by both the investigator and subjects. These study results support the efficacy and tolerability of this multimodality skin brightening regimen in skin of color. 100% sponsored by SkinMedica, an Allergan Company.
Results: The overall prevalence of eyelash hypotrichosis in surveyed subjects was 83.1% (695% confidence interval: 81.3-84.9%). The prevalence increased with age, from 69.7% in the 18-24 years age group, to 84.6% in the 35-39 years age group, and 97.2% in the ¼60 years age group. Subject-reported eyelash satisfaction showed that 19.8% of subjects were unsatisfied or very unsatisfied with their eyelash length; similarly, 19.8% were unsatisfied or very unsatisfied with their eyelash fullness/thickness. Overall eyelash satisfaction results showed that 16.7% of subjects were unsatisfied or very unsatisfied with their eyelashes. However, the majority of surveyed subjects (82.5%) were interested in improving their eyelash appearance; 39.4% of subjects \ 50 years were extremely or very interested in improving their eyelash appearance compared to 19.4% of subjects ¼50 years. Additionally, 43.3% of subjects were somewhat or very interested in a safe and effective prescription product to increase the prominence of their eyelashes. Conclusion: More than 83% of adult Chinese female subjects in China exhibit eyelash hypotrichosis. Approximately 17% of subjects were not satisfied with their eyelashes; however, more than 82% were interested in improving their eyelash appearance and more than 43% were interested in a safe and effective prescription product to increase the prominence of their eyelashes. Sponsored by Allergan, Inc, Irvine, CA. Editorial assistance was provided to the authors by Peloton Advantage, Parsippany, NJ and was funded by Allergan, Inc.
1284 Efficacy of ATX-101 for reducing submental fullness associated with submental fat in demographic subgroups of subjects from the US/CAN phase 3 trials, REFINE-1 and REFINE-2 Frederic Brandt, Dermatology Research Institute, LLC, Coral Gables, FL, United States; Corey Maas, Maas Clinic, San Francisco, CA, United States; Paul Lizzul, Kythera Biopharmaceuticals, Westlake Village, CA, United States; Todd Gross, Kythera Biopharmaceuticals, Westlake Village, CA, United States; Frederick Beddingfield, Kythera Biopharmaceuticals, Westlake Village, CA, United States Background: Submental fat (SMF) may present as an unappealing fullness that can negatively affect well-being. ATX-101 is a formulation of pure synthetic deoxycholic acid that causes focal adipocytolysis and has been extensively studied for SMF reduction. This abstract reports efficacy in subgroups of subjects enrolled in the US/CAN phase 3 trials.
1819
Design: In 2 randomized double-blind placebo-controlled trials, REFINE-1 and REFINE-2, subjects with SMF graded moderate or severe by the investigator and by the subject using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported (PR)-SMFRS, respectively, were treated with ATX-101 2 mg/cm2 (area-adjusted) or placebo. The co-primary endpoints were $1-grade improvement from baseline at 12 weeks in composite CR-SMFRS/PR-SMFRS and $2-grade improvement in the composite endpoint. ATX-101 was compared to placebo within 18 subgroups, based on 9 demographic variables (age, sex, race, ethnicity, Fitzpatrick skin type, body mass index (BMI), baseline SMF severity [CR and PR] and baseline skin laxity). Also, $1-grade CR-SMFRS response rates (CR-1) were compared for the 2 demographic subgroups for each variable (eg sex: males vs females). Results: Both coprimary endpoints were met in each study. A pooled analysis of all 1022 randomized subjects (from both studies) showed that 82% of ATX-101 subjects achieved a CR-1 response, compared with 35% of placebo subjects (P \.001). A significant treatment effect of ATX-101 was observed within all 18 subgroups. In ATX-101 subjects, CR-1 response was high in all subgroups ($75%) and $80% in 14 subgroups. When two subgroups of the same demographic were compared, the difference in CR-1 response between the subgroups within the ATX-101 treatment group was not clinically meaningful and ranged from 0.3% (skin laxity) to 8.1% (race), indicating minimal difference in CR-1 responder rates as a function of subject characteristics. In addition, a multivariate logistic regression model predicting responder rates for CR-1 from the 9 demographic variables indicated no effect of 7 of the variables on treatment response, and only slightly higher response rates (not clinically meaningful) for subjects with higher baseline SMF severity (84.3% vs 79.6%, P ¼ .002) and lower BMI (83.8% vs 79.1%, P ¼ .043). Conclusion: These results confirm that ATX-101 is efficacious in reducing SMF and improving submental contour regardless of subject characteristics at baseline.
Evaluation of Merz hand grading scale following calcium hydroxylapatite hand treatment Vince Bertucci, MD, University of Toronto, Toronto, Ontario, Canada; Nowell Solish, MD, University of Toronto, private practice, Toronto, Ontario, Canada Calcium hydroxylapatite (CaHA) is approved for the treatment of hands in Canada. The Merz hand grading scale (MHGS) is used to grade appearance of the dorsal hand on a 5-point scale (0 ¼ no loss of fatty tissue; 4 ¼ very severe loss of fatty tissue; marked visibility of veins and tendons). The MHGS has been previously validated for photographic assessment of the hands. A recent live validation study has demonstrated that the MHGS is suitable for live assessment in clinical studies. The primary objective of this study was to assess the sensitivity of the validated MHGS to detect changes in hand appearance 1 month after CaHA hand treatment. In this randomized, controlled, single-blind study, 41 subjects were screened at 2 investigational sites. Thirty (30) subjects with a live rating of 2 or 3 on the MHGS were enrolled and randomized: 20 subjects to a treatment group and 10 subjects to an untreated control group. Subjects randomized to the treatment group received treatment at enrollment and subjects randomized to the control group received treatment at week 4 after completion of MHGS ratings. CaHA was mixed with lidocaine according to the Canadian Instructions for Use. Subjects received treatment in the dorsum of each hand. The MHGS ratings were made from live assessment of subject hands performed by a qualified and blinded evaluator at baseline, week 2 and 4 visits. Safety was assessed by recording all AEs occurring after hand treatment to the week 4 visit. Effectiveness was also measured using the Global Aesthetic Improvement Scale (GAIS), as well as physician and subject satisfaction questionnaires. All 30 enrolled subjects completed the study. The majority of subjects were female (93.3%) and Caucasian (90.0%) with a mean age of 51.5 years. A significant improvement in MHGS ratings was demonstrated in the Immediate Treatment Group compared to baseline [(0.4 vs 2.5), (0.7 vs 2.5); P \.0001] and to the control [(-2.1 vs -0.1), (-1.8 vs 0.0); P \.0001] at weeks 2 and 4, respectively]. All (100%) subjects in the treatment group had ¼1 point improvement in both hands (P \ .0001). The AEs reported in this study were expected, generally short in duration, and typical of dermal filler injections. Swelling was the most frequently reported AE. The results of this study demonstrate that the MHGS is effective in detecting clinically meaningful effects in the dorsum of hands after treatment with calcium hydroxylapatite.
This study is Sponsored by Kythera Pharmaceuticals.
100% is Sponsored by Merz North America, Inc.
MAY 2015
J AM ACAD DERMATOL
AB17