Collagenase Clostridium Histolyticum-aaes for Treatment of Cellulite: A Pooled Analysis of Two Phase-3 Trials.
In: Plastic and reconstructive surgery. Global open, Jg. 10 (2022-05-25), Heft 5, S. e4306
Online
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Zugriff:
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.)
Titel: |
Collagenase Clostridium Histolyticum-aaes for Treatment of Cellulite: A Pooled Analysis of Two Phase-3 Trials.
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Autor/in / Beteiligte Person: | Bass, LS ; Kaufman-Janette, J ; Joseph, JH ; Kaminer, MS ; Clark, J ; Fabi, SG ; Gold, MH ; Katz, BE ; Peddy, K ; Schlessinger, J ; Young, VL ; Hurley, D ; McLane, MP ; Vijayan, S ; Liu, G ; Davis, MW ; Goldman, MP |
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Zeitschrift: | Plastic and reconstructive surgery. Global open, Jg. 10 (2022-05-25), Heft 5, S. e4306 |
Veröffentlichung: | [Philadelphia, PA] : Wolters Kluwer Health/Lippincott Williams & Wilkins, [2013]-, 2022 |
Medientyp: | academicJournal |
ISSN: | 2169-7574 (print) |
DOI: | 10.1097/GOX.0000000000004306 |
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