Efficacy and Safety of a New Resilient Hyaluronic Acid Filler in the Correction of Moderate-to-Severe Dynamic Perioral Rhytides: A 52-Week Prospective, Multicenter, Controlled, Randomized, Evaluator-Blinded Study. Issue 1 (January 2022)

• Record Type: Journal Article
• Authors: Sundaram, Hema; Shamban, Ava; Schlessinger, Joel; Kaufman-Janette, Joely; Joseph, John H.; Lupin, Mark; Draelos, Zoe; Carey, Wayne; Smith, Stacy; Eaton, Laura
• Is Part Of: Dermatologic surgery. Volume 48:Issue 1(2022)
• Publication Date: 2022-01
• Subjects: Skin -- Surgery -- Periodicals; Skin -- Diseases -- Surgery -- Periodicals; 617.477
• DOI: 10.1097/DSS.0000000000003238
• Languages: English
• ISSNs: 1076-0512

Abstract

Abstract : BACKGROUND: The perioral region is highly mobile and subject to multifactorial changes during aging. Resilient Hyaluronic Acid Redensity (RHAR ), an RHA filler, was developed with the aim of optimizing outcomes in dynamic facial areas. OBJECTIVE: This randomized, blinded, multicenter clinical study aimed to demonstrate superiority of RHAR over no-treatment control for correction of moderate-to-severe dynamic perioral rhytides. MATERIALS AND METHODS: Blinded live evaluator assessments of efficacy included improvement in perioral rhytides severity using a proprietary scale (Perioral Rhytids Severity Rating Scale [PR-SRS]) and the Global Aesthetic Improvement Scale. Subjects self-assessed their results with FACE-Q, a validated patient-reported outcome measure, and satisfaction scales. Safety was monitored throughout the study based on common treatment responses (CTRs) and adverse events (AEs). RESULTS: The primary efficacy end point was achieved, with the treatment group showing statistically significant superiority over the control group at Week 8 (80.7% vs 7.8% responder rate by PR-SRS, p < .0001). Most patients (66%) were still responders at Week 52 (study completion). Most AEs were CTRs after perioral injection of a dermal filler, and none was a clinically significant treatment-related AE. CONCLUSION: Resilient Hyaluronic Acid Redensity is effective and safe for the correction of dynamic perioral rhytides in all Fitzpatrick phototypes, with marked durability. Abstract : Supplemental Digital Content is Available in the Text.