Hyamax® Monophasic Volumizer Dermal Fillers for Chin Restoration: A Prospective, Single-Center, Investigator-Blinded, Randomized Controlled Trial.

Abstract

Background: Hyamax® Monophasic Volumizer Dermal Fillers is a newly designed hyaluronic acid soft tissue filler for chin augmentation.

Methods: A prospective, single-center, evaluator-blinded, randomized controlled study was designed to evaluate the effectiveness and safety of Hyamax® Volumizer in the correction of chin retrusion in the 18-55-year-old Chinese population for 12 months after treatment. Participants were randomized (3:1) to receive Hyamax® Volumizer injection (n = 21) or no treatment (n = 7). Assessments included live and blinded evaluations by photographs on a chin retrusion scale (Galderma Chin Retrusion Scale), aesthetic improvement (Global Aesthetic Improvement Scale) by the subjects and independent evaluators, and safety follow-up at 3, 6, 9, and 12 months.

Results: Hyamax® Volumizer was superior in improving chin retrusion at 6 months with a GCRS response rate of 57.14% versus 0% of the controls (P<0.0001) meeting the primary effectiveness objective. The GCRS and GAIS scores by subjects and evaluators achieved remarkable improvement at all follow-up points compared with the control group through 12 months. Common ISRs were injection-site pain (90.48%), tenderness (80.95%), redness (47.62%) and ecchymosis (19.05%). No serious treatment-related advert events were reported.

Conclusion: Hyamax® Volumizer significantly restored the facial volume and improved the chin projection with safety.

Level of evidence i: 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 .