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

• Published in: Plastic and reconstructive surgery. Global open Vol. 10; no. 5; p. e4306
• Main Authors: Bass, Lawrence S, Kaufman-Janette, Joely, Joseph, John H, Kaminer, Michael S, Clark, James, Fabi, Sabrina G, Gold, Michael H, Katz, Bruce E, Peddy, Kappa, Schlessinger, Joel, Young, V Leroy, Hurley, David, McLane, Michael P, Vijayan, Saji, Liu, Genzhou, Davis, Matthew W, Goldman, Mitchel P
• Format: Journal Article
• Language: English
• Published: United States Lippincott Williams & Wilkins 25.05.2022; Wolters Kluwer
• Subjects: Cosmetic; Original
• ISSN: 2169-7574; 2169-7574
• DOI: 10.1097/GOX.0000000000004306

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. 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. 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]; < 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%; < 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 . The most common adverse events with CCH-aaes were injection-site bruising and injection-site pain. CCH-aaes treatment significantly improved moderate-to-severe buttock cellulite appearance and was generally well tolerated.