Efficacy, Safety, and Durability of Response of Collagenase Clostridium Histolyticum-aaes for Treating Cellulite

Abstract

Background: Collagenase clostridium histolyticum-aaes (CCH) enzymatically releases fibrous septa that contribute to the skin dimpling characteristic of cellulite. Long-term safety/duration of efficacy (durability) results from an open-label extension (OLE) of a randomized, double-blind, placebo-controlled trial (RCT) evaluating CCH efficacy/safety for moderate-to-severe cellulite of the buttocks or posterolateral thighs in women was assessed. Efficacy/safety of CCH treatment/retreatment during OLE was also evaluated. Methods: After RCT unblinding, women could enroll in OLE for assessment of long-term CCH durability (observation only, up to day 720) or CCH treatment/retreatment, the latter in women with moderate-to-severe buttock/posterolateral thigh cellulite [Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported PCSS (PR-PCSS) scores of 3/4; Hexsel Cellulite Severity Scale score ≤13]. A treatment/retreatment course comprised 1 or 2 courses of 3 sessions (0.84-mg CCH injected at days 1, 22, and 43). CCH efficacy/safety was assessed at baseline, days 22, 43, 71, and quarterly at day 360. Results: Of the 259 OLE participants, 53 were observed for long-term CCH durability. For those who were ≥2-level composite responders during RCT (≥2-point CR-PCSS/PR-PCSS score improvements), CCH effect was durable (scores did not reach RCT baseline levels) in all women on days 180 (19/19), 360 (16/16), and 720 (7/7). Of the 200 women receiving CCH treatment/retreatment, more than 75% had ≥1-level improvement in patient and clinical assessments at day 71. The most common adverse events were injection-site bruising and pain. Conclusions: CCH treatment provided durable improvement in moderate-to-severe buttock/thigh cellulite and was generally well tolerated. Repeated CCH exposure did not increase adverse event risk or reduce efficacy.

Efficacy of an Anti-Cellulite Herbal Emgel: A Randomized Clinical Trial

“…These are credible possibilities acting alone or in concert but our data is unable to distinguish their contributions. Nevertheless, these arguments support the notion that the improved appearance of cellulite arises from the localised treatment, an assertion supported by our previous study [ 8 ] and several other studies [ 11 , 12 , 13 , 14 ].…”

Cellulite: Presentation and management

“…In an open‐label extension of a previous phase 2 randomized controlled trials, women with moderate‐to‐severe cellulite were subcutaneously administered CCH 0.84 mg in three treatment sessions perpendicular and at 45° angle to the skin in 0.1‐ml aliquots. Improvements were observed to last through 2‐year follow‐up 54,55 …”

“…Improvements were observed to last through 2-year follow-up. 54,55 Qwo™ (CCH-aaes) is approved by the FDA for the treatment of moderate-to-severe cellulite in the buttocks of adult women. 56…”

Evaluation of five collagenase clostridium histolyticum‐aaes injection techniques for the treatment of cellulite on the buttock or thigh

“…Collagenase clostridium histolyticum‐aaes (CCH‐aaes; Qwo ® ) is indicated in the United States for the treatment of moderate‐to‐severe cellulite in the buttocks of adult women, 1 with demonstrated efficacy and safety in phase 2 and phase 3 trials. 2 , 3 , 4 CCH‐aaes treatment for thigh cellulite is currently investigational. The mechanism of action of CCH‐aaes is attributed to Enzymatic Subcision and Remodeling™ (ESR™).…”