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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

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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 1:1 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.

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Funding

Funding for this study was received in the form of a Grant (IIT5126) by Merz North America, Inc.

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Authors and Affiliations

  1. A Medical Corp, 800 S Fairmount Ave, Suite 325, Pasadena, CA, 91105, USA

    Kay Durairaj, Omer Baker, Monalea Yambao & Jacob Linnemann-Heath

  2. Division of Physician Assistant Studies, USC Keck School of Medicine, Los Angeles, CA, USA

    Ani Shirinyan

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Correspondence to Kay Durairaj.

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Conflict of interest

Dr. Durairaj reports personal fees and other from Galderma, grants, personal fees, non-financial support and other from Merz Aesthetics, personal fees and other from Allergan Aesthetics, personal fees and other from Prollenium, personal fees from Evolus, personal fees from Informa, personal fees from Canadian Association of Aesthetic Medicine, outside the submitted work. OB, MY, JL-H, and AS have nothing to disclose.

Human and Animal Rights

All procedures performed in studies involving human participants were done in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study was approved by an institutional review board (Allendale Investigational Review Board, ID: KD2019). All enrolled subjects provided written informed consent prior to inclusion in the study, as well as written permission for the use of their photographic records.

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Durairaj, K., Baker, O., Yambao, M. et al. 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. Aesth Plast Surg 48, 1797–1806 (2024). https://doi.org/10.1007/s00266-023-03815-z

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