LAUSR

BACKGROUND Clostridium histolyticum (CCH-aesthetic formulation [CCH-aaes]) is a recently approved, targeted enzymatic treatment for cellulite in the buttock. Cellulite also develops in thighs, and the treatment areas require different injection techniques and product dilutions. OBJECTIVES This Phase 4 study aims to assess the effectiveness of multiple concentrations of CCH-aaes for the concomitant treatment of mild to moderate cellulite in the buttock and thighs of adult females. METHODS Cellulite severity was assessed using the Investigator Global Aesthetic Improvement Scale (I-GAIS) on days 1, 22, 43, and 90, and the Body-Q appraisal of cellulite and the Clinician Reported-Photonumeric Cellulite Severity Scale (CR-PCSS) on days 1 and 90. Treatments were performed on buttock and thigh dimples on days 1, 22, and 43 with reference to a provided calculation matrix, which is based upon the reconstitution, dilution, and injection patterns and volumes identified as optimal for these distinct areas by early research endeavors. The matrix permits customization to the desired number and location of cellulite dimples to be treated. RESULTS Among the 5 subjects treated, 3 experienced improvement of cellulite severity in both treatment areas as measured by all 3 scales, and 2 participants showed improvement or no change in CR-PCSS and Body-Q Appraisal of Cellulite and worsening I-GAIS scores for one or both treatment areas. CONCLUSIONS This study suggest that use of CCH-aaes in the concurrent treatment of the thigh and buttocks is predictable and efficacy and safety are similar for both areas.