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

Hema Sundaram, Ava Shamban, Joel Schlessinger, Joely Kaufman-Janette, John H Joseph, Mark Lupin, Zoe Draelos, Wayne Carey, Stacy Smith, Laura Eaton, Hema Sundaram, Ava Shamban, Joel Schlessinger, Joely Kaufman-Janette, John H Joseph, Mark Lupin, Zoe Draelos, Wayne Carey, Stacy Smith, Laura Eaton

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.

Trial registration: ClinicalTrials.gov NCT03092219.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.

Figures

Figure 1.
Figure 1.
Perioral Rhytids Severity Rating Scale (PR-SRS). A proprietary 4-grade rating scale [0–3].
Figure 2.
Figure 2.
Effectiveness end points at Week 8 in the treatment group versus no-treatment control, and throughout the study in the pooled population.
Figure 3.
Figure 3.
Before (A) and after (B) photographs of a 69-year-old female subject with moderate perioral rhytides at baseline (A), who improved to mild at Week 8 posttreatment (B). Initial volumes injected into the upper and lower perioral rhytides were, respectively, 0.6 and 0.4 mL, with touch-up volumes of 0.5 and 0.4 mL. Injection techniques were retrograde linear threading and serial punctures.

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Source: PubMed

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