Safety and Efficacy of Diluted Calcium Hydroxylapatite for the Treatment of Cellulite Dimpling on the Buttocks: Results from an Open-Label, Investigator-Initiated, Single-Center, Prospective Clinical Study.

ABSTRACT

BACKGROUND: Cellulite is a condition characterized by dimpling and contour irregularities in the gluteal and thigh regions, affecting an estimated 80-98% of postpubertal women. Innovative treatments for cellulite dimpling in the buttocks have gained popularity in recent years, seeking new solutions for a historically challenging condition. In this open-label, investigator-initiated, single-center, prospective clinical study, the authors sought to evaluate the safety and efficacy of diluted calcium hydroxylapatite (CaHA; Radiesse®, Merz Aesthetics, Raleigh, NC) for the treatment of cellulite dimpling in the buttocks of adult women. METHODS: Subjects underwent three treatment sessions, receiving a total of 12 syringes of 11 diluted CaHA administered using a cannula-based subcision technique. Endpoints included the cellulite severity scale (CSS), the global aesthetic improvement scale (GAIS), subject satisfaction measured on a 5-point scale, and three-dimensional imaging analysis via the Quantificare 3D Track®. RESULTS: Twenty-four subjects completed the study (mean age, 35 years; mean BMI, 26.88 kg/m2; mean body fat percentage, 31.29%), and no serious complications were reported. Quantitative analysis at week 14 revealed a mean reduction of 54.0% in the number of visible dimples and 50.09% in dimple depth compared to baseline. The mean CSS score decreased by 4.29 points, representing a 43.92% improvement in cellulite severity from baseline (p < 0.0001). Both physician-assessed and subject-assessed GAIS ratings also demonstrated significant improvement, with 91.6% of subjects rating their cellulite appearance as "improved" or greater. CONCLUSION: The results of this study support the safety and efficacy of diluted CaHA for treating cellulite dimpling in adult women. LEVEL OF EVIDENCE II This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors   www.springer.com/00266 . CLINICAL TRIALS REGISTRATION This study is registered with clinicaltrials.gov (ID NCT05885035) and can be found at this link https//clinicaltrials.gov/study/NCT05885035 .