Collagenase Clostridium Histolyticum-aaes for the Treatment of Cellulite in Women: Results From Two Phase 3 Randomized, Placebo-Controlled Trials. Issue 5 (7th May 2021)

• Record Type: Journal Article
• Authors: Kaufman-Janette, Joely; Joseph, John H.; Kaminer, Michael S.; Clark, James; Fabi, Sabrina G.; Gold, Michael H.; Goldman, Mitchel P.; Katz, Bruce E.; Peddy, Kappa; Schlessinger, Joel; Young, V. Leroy; Davis, Matthew; Hurley, David; Liu, Genzhou; McLane, Michael P.; Vijayan, Saji; Bass, Lawrence S.
• Is Part Of: Dermatologic surgery. Volume 47:Issue 5(2021)
• Page Start: 649
• Page End: 656
• Publication Date: 2021-05-07
• Subjects: Skin -- Surgery -- Periodicals; Skin -- Diseases -- Surgery -- Periodicals; 617.477
• DOI: 10.1097/DSS.0000000000002952
• Languages: English
• ISSNs: 1076-0512

Abstract

Abstract : BACKGROUND: Fibrous septae play a role in contour alterations associated with cellulite. OBJECTIVE: To assess collagenase clostridium histolyticum-aaes (CCH) for the treatment of cellulite. MATERIALS AND METHODS: Two identically designed phase 3, double-blind, randomized studies (RELEASE-1 and RELEASE-2) were conducted. Adult women with moderate/severe cellulite (rating 3–4 on the Patient Reported Photonumeric Cellulite Severity Scale [PR-PCSS] and Clinician Reported PCSS [CR-PCSS]) on the buttocks received up to 3 treatment sessions of subcutaneous CCH 0.84 mg or placebo per treatment area. Composite response (≥2-level or ≥1-level improvement from baseline in both PR-PCSS and CR-PCSS) was determined at Day 71. RESULTS: Eight hundred forty-three women received ≥1 injection (CCH vs placebo: RELEASE-1, n = 210 vs n = 213; RELEASE-2, n = 214 vs n = 206). Greater percentages of CCH-treated women were ≥2-level composite responders versus placebo in RELEASE-1 (7.6% vs 1.9%; p = .006) and RELEASE-2 (5.6% vs 0.5%; p = .002) and ≥1-level composite responders in RELEASE-1 (37.1% vs 17.8%; p < .001) and RELEASE-2 (41.6% vs 11.2%; p < .001). Most adverse events (AEs) in the CCH group were injection site related; few CCH-treated women discontinued because of an AE (≤4.3%). CONCLUSION: Collagenase clostridium histolyticum-aaes significantly improved cellulite appearance and was generally well tolerated.