Journal of Clinical and Aesthetic Dermatology

MauiDerm Abstract Supplement 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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[ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] S U P P L E M E N T T O T H E J O U R N A L O F C L I N I C A L A N D A E S T H E T I C D E R M AT O L O G Y S7 S 7 w ith severe skin laxity were excluded. Results: Among ATX-101-treated subjects with a composite ≥1-grade response (n=328), skin laxity was improved in 22.9 percent, unchanged i n 70.1 percent, and worse in 7.0 percent. In ATX-101–treated MRI responders (n=86), skin laxity was improved in 27.9 percent, unchanged in 65.1 percent, and worse in 7.0 p ercent. In ATX-101–treated subjects who achieved a composite ≥2-grade response (n=79), skin laxity was improved in 24.1 percent, unchanged in 70.9 percent, and worse in 5.1 percent. In placebo-treated subjects with a composite ≥1-grade response (n=95), skin laxity was improved in 33.7 percent, unchanged in 61.1 percent, and worse in 5.3 percent. Too few placebo-treated subjects achieved a MRI response or composite ≥2-grade response for meaningful assessment of skin laxity. Conclusion: In ATX-101-treated subjects from the REFINE trials who responded to treatment (regardless of the efficacy measure), skin laxity infrequently worsened, and in most subjects was unchanged or improved. Importantly, a rating of unchanged or improved occurred in the setting of SMF volume loss wherein one might expect worsening of skin laxity. We hypothesize that the controlled inflammatory response following ATX- 101 treatment may induce neocollagenesis, which could play a role in skin retracting as SMF is reduced. The multiple injections used in the treatment procedure may also have contributed a modest degree to improvements in skin laxity in both treatment groups. Safety and Efficacy of ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat: Results from a Multicenter, Open- Label Phase 3b Trial Presenters: 1 Kenneth R. Beer; 2,3 Susan H. Weinkle; 4,5 Sue Ellen Cox; 6 Mark G. Rubin; 7 Jeffrey M. Adelglass; 8 Paul F. Lizzul; 8 Todd M. Gross; 8,9 Frederick C. Beddingfield, III; 8 Christine Somogyi Affiliations: 1 Beer Surgical, Aesthetic and General Dermatology, W est Palm Beach, FL; 2 U niversity of South Florida, Tampa, FL; 3 Private Practice, Bradenton, FL; 4 University of North Carolina, Chapel Hill, Chapel Hill, NC; 5 Aesthetic Solutions, Chapel Hill, N C; 6 L asky Skin Center, Beverly Hills, CA; 7 SKINTASTIC Medical & Surgical Rejuvenation Center, Plano, TX; 8 Allergan plc, Irvine, CA; 9 David Geffen School of Medicine, University of C alifornia Los Angeles, Los Angeles, CA Background: ATX-101 (deoxycholic acid injection) was recently approved in the United States and Canada as an injectable treatment for submental fat (SMF) reduction. This Phase 3b trial (NCT01426373) evaluated the safety and efficacy of ATX-101 in subjects followed for up to 12 months after last treatment. Methods: Overall, 165 adults with SMF graded as moderate to extreme on validated Clinician- and Patient- Reported SMF Rating Scales (CR- SMFRS and PR-SMFRS, respectively) were enrolled. Subjects received up to a maximum of six treatments of ATX- 101 (2mg/cm 2 ). Efficacy endpoints, evaluated at 12 weeks and 12 months after last treatment, included percent of subjects who achieved a ≥1-grade improvement in SMF severity based on CR-SMFRS or PR-SMFRS (CR-1 or PR-1 response); mean reduction in the psychological impact of SMF (assessed using the Patient-Reported Submental Fat Impact Scale [PR-SMFIS]); mean percent reduction in SMF via calipers; and percent of subjects satisfied with their face/chin (assessed using the Subject Self-Rating Scale [SSRS]). Safety was monitored, including spontaneous adverse event (AE) reports and skin laxity (using the Submental Skin Laxity Grading [SMSLG] Scale). Impact of treatment on work and social/leisure activities was evaluated by subject questionnaire. Results: At 12 weeks after last treatment, 87 percent of subjects achieved a CR-1 response and 84 percent achieved a PR-1 response; of these responders, 90 percent and 81 percent maintained their CR-1 and PR- 1 response, respectively, at 12 months after last treatment. At baseline, subjects reported marked p sychological impact of SMF (mean PR-SMFIS: 7.0/10 [10=worst impact]). The psychological impact of SMF was reduced by 61 percent at 12 weeks after last treatment (mean change f rom baseline:-4.3), which was maintained at 12 months after last treatment (-4.2). By caliper assessments, SMF was reduced by 27 percent at 12 weeks after last t reatment; this reduction was maintained at 12 months after last treatment (31%). At 12 weeks after last treatment, 88 percent of subjects were satisfied with their face/chin; 85 percent were still satisfied at 12 months after last treatment. AEs were reported in 97 percent of subjects; most were related to the treatment area (bruising, numbness, pain, swelling), mild/moderate, transient, and resolved. The incidence of AEs decreased over subsequent treatments. At 12 months after last treatment, 93 percent of subjects had stable or improved skin laxity. Questionnaire results showed that a majority of subjects chose not to forgo work or social/leisure activities in the immediate post-treatment period. Conclusion: ATX-101 treatment reduced SMF and the psychological impact of SMF without worsening skin laxity. SMF reductions and subject satisfaction achieved at 12 weeks after last treatment were maintained over 12 months of follow-up. ATX-101 exhibited a safety profile expected for a facial injectable with most AEs related to the treatment area. For most subjects, downtime was minimal and occurred most commonly after the first treatment. Retrospective Safety Study of Combining Micro-Focused Ultrasound with Visualization (MFU-V) with Neurotoxins and Fillers (HA and CaHA) Presenters: 1 William P. Werschler, MD, FAAD, FAACS; 2 Sabrina G. Fabi, MD, FAAD, FAACS; 3 Jeremy B. Green, MD, FAAD; 4 Daniel C. Mills II, MD, FACS; 5 Robert Weiss, MD Affiliations: 1 Spokane Dermatology Clinic/Premier Clinical Research; 2 Cosmetic Laser Dermatology; 3 Skin Research Institute; 4 Aesthetic Plastic

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