Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
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Stabilized hyaluronic acid gel for volume restoration and contouring of the buttocks: 24-month efficacy and safety.

BACKGROUND: Stabilized hyaluronic acid (HA) of nonanimal origin manufactured using the patented NASHA® technology has been developed for use in body shaping. This study was performed to assess the safety and efficacy of stabilized HA gel when used for volume restoration and contouring of the buttocks.

METHODS: Subjects 20 years of age or older seeking buttock augmentation were recruited to this noncomparative multicenter study (NCT01331408). Gel at a maximum volume of 400 mL per subject was injected during one or two treatment visits. Safety and efficacy assessments (24-month follow-up evaluation) included adverse event (AE) reporting, aesthetic improvement (Global Aesthetic Improvement Scale [GAIS]), and subject satisfaction.

RESULTS: In this study, 61 subjects received a mean total volume of 340 mL (range 200-420 mL) of stabilized HA gel. According to subject GAIS assessment, buttock appearance was rated as "improved," "much improved," or "very much improved" by 80, 68, 42, and 40% of subjects after 6, 12, 18, and 24 months, respectively. Subject satisfaction with buttock size, shape, firmness, and general appearance was higher than before treatment at all the time points, with a peak of 70% of the subjects satisfied 1 month after treatment. During the 24 months, no unexpected or serious treatment-related AEs occurred. One subject experienced gel dislocation to the sacral area.

CONCLUSIONS: The data show that stabilized HA gel is a safe and effective treatment for temporary aesthetic augmentation of the buttocks. Although the substance degrades over time, a good proportion of the subjects still rated their buttocks as improved (40%) and expressed satisfaction (33%) 24 months after treatment.

LEVEL OF EVIDENCE IV: 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 .

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