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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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 [ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] S urgery Institute; 5 L aser Skin and Vein Objectives: To evaluate micro- focused ultrasound with visualization (MFU-V) for its potential interaction with botulinum toxin A (BoNTA) a nd/or permanent and temporary dermal fillers Methods: One hundred one subjects were enrolled in this retrospective, two-year chart review. Treatment d ates, volume of product used, and treatment areas were collected. Subjects underwent a combination treatment with MFU-V and BoNTA injection, hyaluronic acid (HA) dermal filler, and/or calcium hydroxylapatite (CaHA) dermal filler within six months of MFU-V. Treatments were in the face and/or neck regions. Data on other aesthetic procedures were also captured. Results: Male (n=4) and female (n=96) subjects were enrolled. The average age was 55.32. Of the 101 subjects receiving MFU-V, 81 percent also received either HA/CaHA, two percent received both HA/CaHA and BoNTA injection, and 18 percent received BoNTA. Of the 83 receiving HA/CaHA, 69 percent received HA and 31 percent received CaHA. Fifty-nine percent of subjects received treatments/procedures beyond MFU-V and products detailed above. Seven adverse events were reported in seven subjects. Three adverse events were related to the MFU-V treatment, three to HA/CaHA, and one to a combination of MFU-V, BoNTA injection, hyaluronic acid with Gram-positive bacterial proteins and hyaluronic acid. Adverse events were bruising/purpura x 4, swelling, paresthesia, and HSV outbreak. HSV outbreak was related to combination therapy. Adverse events were mild in nature with the exception of one "moderate" bruising (related to MFU-V). Minor medical interventions were undertaken to resolve six of the adverse events with one not requiring intervention. Conclusion: Safety data has shown that there are no serious adverse events or increase in adverse events and suggests that the safety profile of MFU-V combined with other aesthetic products is similar to that of the individual treatment/product. M ulticenter Pivotal Study of the Safety and Effectiveness of a Tissue Stabilized-Guided Subcision Procedure for the Treatment of Cellulite- Interim 3 Y ear Update Presenter: Joel Cohen, MD Investigators: Michael S. Kaminer, MD; Deanne M. Robinson, MD; William P. Coleman III, MD; Robert A. Weiss, M D; W. Patrick Coleman IV, MD Background: Tissue release (subcision) for cellulite has been practiced for decades with limited success. A novel procedure has been developed which stretches and stabilizes tissue while providing integrated anesthesia delivery and precise depth control of minimally invasive tissue release. The purpose of this study was to determine the safety and efficacy of a new tissue stabilized- guided subcision (TS-GS) system for the treatment of cellulite. Design: A pivotal prospective multi- centered safety and effectiveness study enrolled 55 subjects. Subjects served as their own controls, underwent a single treatment, and were followed at regular intervals out to three years. Safety was assessed and effectiveness was evaluated by blinded, independent physician evaluators using randomized (before/after) professional photographs and a novel, validated 5- point severity scale. Results: Treatments were well- tolerated with minor expected side effects that resolved quickly. Improvement was rapid and pronounced. Fifty-two subjects completed two-year follow-ups. Two- year average reduction in cellulite severity was 2.0 points (p<0.0001) and masked evaluator improvement was 98 percent. At two years, evaluators rated 100 percent of subjects as having noticeable improvement, and 96 percent of subjects were either satisfied or very satisfied. Forty-five subjects have completed three-year follow-ups with 93 percent either satisfied or very satisfied. Conclusion: Tissue release at precise depths leads to significant, lasting improvement in cellulite. The results of this study showed a single t reatment with a novel TS-GS release system improved the appearance of cellulite on the thighs and buttocks through two years of follow-up with minimal adverse effects. This study s upported the FDA- clearance of the device as an effective and safe treatment for the long-term improvement in the appearance of cellulite of the buttocks and thighs w ith no diminishment of benefit for up to two years. Three-year data will be available and presented. A Double-blind, Randomized Study to Compare Microcyn Scar Management HydroGel, K103163, and Kelo-cote Scar Gel for Hypertrophic or Keloid Scars Presenters: 1 Alicia D. Bucko, DO, CPI, JD; 2 Zoe Draelos, MD; 3 Janet C. Dubois, MD; 4 Terry M. Jones, MD Affiliations: 1 Academic Dermatology Associates, Albuquerque, NM; 2 Dermatology Consulting Services, High Point, NC; 3 DermResearch, Inc., Austin, TX; 4 J&S Studies, Inc. College Station, TX Introduction: Microcyn Scar Management HydroGel was developed to improve the appearance of scars and relieve the itching and pain associated with scars. This randomized, double-blind study compared the efficacy, safety and tolerability of Microcyn scar gel with that of a comparator device, Kelo-cote scar gel, for the management of hypertrophic or keloid scars. Methods: At four sites, 44 adults (aged 18–65 years) were randomized 1:1 to Microcyn scar gel or comparator. Each subject had a target linear or widespread hypertrophic or keloid scar resulting from a wound that had healed 3 to 12 months earlier. Subjects applied treatment thrice daily for eight weeks. Endpoints included the Vancouver Scar Scale (VSS), subject- rated pain and itch assessment, subject satisfaction, and investigator global assessment (IGA). Results: The vascularity, pliability, and height of target scars, as measured by the VSS, improved consistently over the course of the study. At Day 56, the mean total VSS had decreased by 2.10 and 1.28 in the Microcyn scar gel and S 8

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