Collagenase Clostridium Histolyticum-aaes for Treatment of Cellulite: A Pooled Analysis of Two Phase-3 Trials.

Autor:	Bass LS; Bass Plastic Surgery PLLC, New York, N.Y., Kaufman-Janette J; Skin Associates of South Florida, Coral Gables, Fla., Joseph JH; John H. Joseph Facial Plastic and Reconstructive Surgery, Encino, Calif., Kaminer MS; SkinCare Physicians, Chestnut Hill, Mass., Clark J; Charlottesville Medical Research, Charlottesville, Va., Fabi SG; Cosmetic Laser Dermatology, A West Dermatology Company, San Diego, Calif., Gold MH; Tennessee Clinical Research Center, Nashville, Tenn., Katz BE; Juva Skin & Laser Center, New York, N.Y., Peddy K; The Education & Research Foundation, Lynchburg, Va., Schlessinger J; Skin Specialists, P.C., Omaha, Neb., Young VL; Mercy Health Research, Washington, Mo., Hurley D; Endo Pharmaceuticals, Inc., Malvern, Pa., McLane MP; Endo Pharmaceuticals, Inc., Malvern, Pa., Vijayan S; Endo Pharmaceuticals, Inc., Malvern, Pa., Liu G; Endo Pharmaceuticals, Inc., Malvern, Pa., Davis MW; Endo Pharmaceuticals, Inc., Malvern, Pa., Goldman MP; Cosmetic Laser Dermatology, A West Dermatology Company, San Diego, Calif.
Jazyk:	angličtina
Zdroj:	Plastic and reconstructive surgery. Global open [Plast Reconstr Surg Glob Open] 2022 May 25; Vol. 10 (5), pp. e4306. Date of Electronic Publication: 2022 May 25 (Print Publication: 2022).
DOI:	10.1097/GOX.0000000000004306
Abstrakt:	Background: Collagen-rich fibrous septae and subcutaneous adipose protrusions play a role in cellulite pathophysiology. Collagenase clostridium histolyticum-aaes (CCH-aaes) injection causes enzymatic release of septae to resolve cellulite depressions and create a skin smoothing effect. This analysis pooled data from two identically designed, phase-3, randomized, double-blind, placebo-controlled studies to examine the efficacy and safety of CCH-aaes. Methods: Adult women with moderate/severe cellulite (3-4 on Clinician Reported Photonumeric Cellulite Severity Scale and Patient Reported Photonumeric Cellulite Severity Scale) on the buttocks received up to three treatment sessions (Days 1, 22, and 43) of subcutaneous CCH-aaes 0.84 mg or placebo per treatment area. Composite and individual component response (≥2-level or ≥1-level improvement from baseline in Patient Reported Photonumeric Cellulite Severity Scale and/or Clinician Reported Photonumeric Cellulite Severity Scale) and additional patient-reported outcomes were determined at Day 71. Results: Analysis included 424 CCH-aaes-treated and 419 placebo-treated women. CCH-aaes-treated women were 5.9 times more likely than placebo-treated women to be ≥2-level composite responders at Day 71 (odds ratio [95% confidence interval], 5.9 [2.2-15.4]; P < 0.001). A significantly greater percentage of CCH-aaes-treated women versus placebo-treated women were ≥1-level composite responders at Day 71 (39.4% versus 14.6%; P < 0.001). Subgroup analyses indicated no apparent impact of Fitzpatrick skin type category and baseline cellulite severity (moderate/severe) on CCH-aaes efficacy. An inverse relationship between age and CCH-aaes response was observed in those with a body mass index less than 32 kg per m 2 . The most common adverse events with CCH-aaes were injection-site bruising and injection-site pain. Conclusion: CCH-aaes treatment significantly improved moderate-to-severe buttock cellulite appearance and was generally well tolerated. (Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons.)
Databáze:	MEDLINE
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