Improvement in Temple Hollowing with VYC-20L Hyaluronic Acid Filler: A Multicenter, Randomized Controlled Trial of Safety and Effectiveness.

Abstract

Background: Temple hollowing is characterized by the reduction of volume in the temporal fossa, which can result in a skeletonized look and contribute to an aged appearance. This study aimed to evaluate the safety and effectiveness of the VYC-20L injectable gel for improvement of temple hollowing.

Methods: Adults with minimal, moderate, or severe temple hollows were randomized 2:1 to receive VYC-20L or no treatment. Participants were followed for 13 months for safety and effectiveness assessments. Treatment effectiveness was assessed by blinded evaluating investigators using the validated Allergan Temple Hollowing Scale (ATHS) and the Global Aesthetic Improvement Scale (GAIS), and by participants using GAIS, FACE-Q scales, and patient satisfaction questionnaires. Adverse events and injection site responses (ISRs) were monitored.

Results: At Month 3, 80.4% of the treatment group vs 13.5% of the untreated control group achieved a ≥1-grade improvement in both temples on the ATHS (P < 0.0001). The ATHS responder rate remained high throughout Month 13. The GAIS responder rates at Month 3 (responses of Improved or Much improved) were high in the treatment group, as assessed by the blinded evaluating investigator (83.8%) and participants (92.9%). Furthermore, satisfaction with Facial Appearance and Temples on the FACE-Q questionnaires increased significantly from baseline (both P < 0.0001). Adverse events and ISRs were mostly mild and consistent with the known safety profile of fillers.

Conclusions: VYC-20L treatment showed favorable safety and effectiveness results in restoring temple volume, with significant aesthetic improvement and high participant satisfaction. Treatment effects lasted for over a year.