Aesthet Surg J. 2023 Aug 10:sjad251. doi: 10.1093/asj/sjad251. Online ahead of print.
ABSTRACT
BACKGROUND: People of color (POC) are often underrepresented in clinical studies evaluating the safety and effectiveness of aesthetic products, including hyaluronic acid (HA) fillers, which to date have limited clinical data in POC.
OBJECTIVE: To assess the safety and effectiveness of a new line of dynamic HA fillers (RHA®, Revance, Nashville TN) for treating moderate-to-severe nasolabial folds (NLF) in POC versus non-POC.
METHODS: Post hoc subgroup analyses compared the efficacy and safety of POC versus non-POC subjects treated with RHA2, RHA3, or RHA4 for correction of moderate-to-severe nasolabial folds in the pooled Per Protocol population (N=217) in two clinical trials. Evaluated population cohorts were classified by Fitzpatrick Skin Type (FST) [high FST (IV-VI) versus low FST (I-III)] and by subject-reported race (non-White versus White) relative to baseline at 6, 9, 12, and 15 months.
RESULTS: POC consistently showed greater improvement in wrinkle severity and higher responder rates compared to non-POC, which reached statistical significance at several measured time points. Global aesthetic improvement scores (GAIS) and subject satisfaction were similar for POC and non-POC and remained high throughout the course of the study. Treatment-related adverse event rates were generally lower for high FSTs versus low FSTs, with no reported cases of keloidal scarring.
CONCLUSION: The RHA line of dynamic fillers is well tolerated and effective for the correction of moderate-to-severe nasolabial folds in POC and can be confidently used in this important and growing patient population.
PMID:37556827 | DOI:10.1093/asj/sjad251
