@article{4a73b7fbb45b4877a5494d4744a19467,
title = "Collagenase Clostridium Histolyticum-aaes for Treatment of Cellulite: A Pooled Analysis of Two Phase-3 Trials",
abstract = "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 m2. 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.",
author = "Bass, {Lawrence S.} and Joely Kaufman-Janette and Joseph, {John H.} and Kaminer, {Michael S.} and James Clark and Fabi, {Sabrina G.} and Gold, {Michael H.} and Katz, {Bruce E.} and Kappa Peddy and Joel Schlessinger and Young, {V. Leroy} and David Hurley and McLane, {Michael P.} and Saji Vijayan and Genzhou Liu and Davis, {Matthew W.} and Goldman, {Mitchel P.}",
note = "Funding Information: Disclosure: Lawrence S. Bass reports serving as a consultant and investigator for Cynosure and an investigator for Merz North America. Joely Kaufman-Janette reports serving on advisory boards for Allergan plc (acquired by AbbVie, Inc.), Bonti, Inc. (acquired by Allergan plc), Endo Pharmaceuticals, Inc., Evolus, Inc., and Galderma; and receiving payment for research from Allergan plc, Croma-Pharma GmbH, Endo Pharmaceuticals, Inc., Evolus, Inc., Galderma, Merz North America, Revance Therapeutics, Inc., and Teoxane Laboratories. John H. Joseph reports serving as a clinical investigator and consultant for Endo Pharmaceuticals, Inc. Michael S. Kaminer reports serving as a consultant for Arctic Fox, LLC, ExploraMed, and Soliton, Inc. James Clark reports serving as an investigator for Allergan (acquired by AbbVie, Inc.), Astellas Pharma US, Inc., Biohaven Pharmaceuticals, Endo Pharmaceuticals, Inc., Feelmore Labs, NeuroValens, Noven Pharmaceuticals, Inc., Samumed, LLC, Satsuma Pharmaceuticals, Inc., Teva Pharmaceutical Industries, Ltd., Tonix Pharmaceuticals Holding Corp., Vibrant Pharma, Inc., and Virios Therapeutics, Inc. Sabrina G. Fabi reports receiving research grants from Allergan (acquired by AbbVie, Inc.), Bausch Health Companies, Inc., Galderma Laboratories, L.P., Merz North America, Inc., and Revance Therapeutics, Inc.; and being a speaker and serving as a consultant for Allergan (AbbVie, Inc.), Bausch Health Companies, Inc., Galderma Laboratories, L.P., and Merz North America, Inc. Michael H. Gold reports being a consultant for Aerolase, Alastin, Allergan (acquired by AbbVie, Inc.), Alma Lasers, Almirall, BioFrontera, Candela Healthcare, Clarify MD, Croma-Pharma, DefenAge, Dermira, Inc., EndyMed Medical, Inc., Essence Novel, Galderma Laboratories, L.P., Hugel, Inc., IntraDerm Invasix/InMode, Johnson & Johnson, Joylux, Lumenis, Ltd., Merz, MTF, NanoPass Technologies, Ltd., Neauvia, Novartis, Pierre Fabre/Glytone, Revision, Sensus, Sent{\'e}, Inc., Skinbetter Science, Sofregen Medical, Inc., Stratpharma, Suneva Medical, Viviscal, and Zimmer. Bruce E. Katz reports being a consultant for AbbVie, Inc., Bausch Health Companies, Inc., Aerolase Corp., Allergan (acquired by AbbVie, Inc.), BTL Aesthetics, Carestream Health, Cynosure, Deka, Galderma Laboratories, L.P., InMode, Merz North America, Inc., Pulse Biosciences, and Suneva Medical. Kappa Peddy reports serving as a clinical investigator for Aclaris Therapeutics, Inc., Athenex, Inc., Bayer AG, Follica, Inc., Novan, Inc., and Sol-Gel Technologies. Joel Schlessinger reports having no additional disclosures. V. Leroy Young reports serving as an investigator for Alder Biopharmaceuticals, Allergan plc (acquired by AbbVie, Inc.), Amgen, Inc., Ardea Biosciences, Boehringer Ingelheim, Celgene Corporation, Daiichi Sankyo Co., Ltd., DalCor Pharmaceuticals, Derma Sciences, Inc., Eisai Co., Ltd., Eli Lilly and Company, Endo Pharmaceuticals, Inc., Evidera, Evolus, Inc., Halscion, Inc., Janssen Pharmaceuticals, Inc., Kythera Biopharmaceuticals, MedImmune, Merck & Co., Inc., Neothetics, Inc., Pfizer, Inc., RXi Pharmaceuticals, Sanofi, Takeda Pharmaceuticals U.S.A., Inc., and Therakos, Inc.; serving as a consultant for AirXpanders, Inc., miRagen Therapeutics, Regeneron Pharmaceuticals, Inc., and Sanofi; and receiving registration and travel expenses from Endo Pharmaceuticals, Inc. David Hurley and Saji Vijayan are employees of Endo Pharmaceuticals, Inc. Michael P. McLane, Genzhou Liu, and Matthew W. Davis are former employees of Endo Pharmaceuticals, Inc. Mitchel P. Goldman reports receiving research grants from Allergan (acquired by AbbVie, Inc.), Bausch Health Companies, Inc., Galderma Laboratories, L.P., Merz North America, Inc., and Revance Therapeutics, Inc.; and being a speaker and serving as a consultant for Allergan (acquired by AbbVie, Inc.), Bausch Health Companies, Inc., and Galderma Laboratories, L.P. This study was supported by Endo Pharmaceuticals, Inc., Malvern, Pennsylvania. Publisher Copyright: {\textcopyright} 2022 Lippincott Williams and Wilkins. All rights reserved.",
year = "2022",
month = may,
day = "25",
doi = "10.1097/GOX.0000000000004306",
language = "English",
volume = "10",
pages = "e4306",
journal = "Plastic and Reconstructive Surgery - Global Open",
issn = "2169-7574",
publisher = "Lippincott Williams and Wilkins Ltd.",
number = "5",
}