Real‐world effectiveness and safety of collagenase clostridium histolyticum‐aaes injections for the treatment of thigh cellulite in women: An open‐label study interim analysis

Abstract Background Collagenase clostridium histolyticum‐aaes (CCH‐aaes) is approved in the United States for moderate‐to‐severe cellulite in the buttocks of adult women. Aim Interim analysis to evaluate efficacy/safety of CCH‐aaes in the treatment of thigh cellulite. Methods Data were analyzed from a phase 3, open‐label study (REAL). Women with mild‐to‐moderate cellulite on both thighs (Clinician Reported Photonumeric Cellulite Severity Scale score, 2 or 3) received ≤0.84 mg (volume, 18 ml) of CCH‐aaes subcutaneously, in up to 12 dimples per posterolateral thigh, in up to 3 treatment sessions (Days 1, 22, and 43). Follow‐up was on Day 90 (interim cutoff). A subset of women participated in the concurrent study (PIXELS), which included high‐definition photography and 3D‐image scanning of treatment areas. Results Twenty‐two women (44 thighs) were included in the interim analysis (mean age, 42.3 years; thighs with mild cellulite, 68.2%). Investigators reported high percentages of responders (score of “improved” or better on Investigator Global Aesthetic Improvement Scale) at Day 90 for either thigh (86.4%; primary endpoint) or both thighs (72.7%). Patient‐reported bother due to cellulite was reduced at Day 90; mean change was 15.3 points (85.5% reduction) in BODY‐Q Appraisal of Cellulite Scale total score (possible range, 11–44). In PIXELS analysis, Day 90 3D‐image scans showed improvement from baseline in skin roughness in some of the treated thigh areas. The most commonly reported adverse events were injection‐site bruising and pain (95.5% and 50.0% of patients, respectively). Conclusions CCH‐aaes treatment of mild‐to‐moderate thigh cellulite was effective and generally well tolerated, with markedly reduced cellulite‐related bother.