An Open-Label, Multicenter, Evaluator-Blinded Study to Assess the Efficacy and Safety of a New Hyaluronic Acid-Based Gel Product for Lip Enhancement.

Abstract

A stabilized hyaluronic acid (HA)-based lidocaine-containing gel of nonanimal origin has been developed for lip enhancement. To evaluate the efficacy, safety, and injection procedure of the HA gel in subjects seeking lip enhancement. Thirty subjects were treated in the upper and lower lips. Retreatment was offered at 3 months. Efficacy was assessed over 9 months using the Global Aesthetic Improvement Scale (GAIS), the Medicis Lip Fullness Scale, and a subject questionnaire. Safety was assessed by a 14-day subject diary and recording of adverse events (AEs) during the whole study. Over 9 months after treatment, 86% to 97% of subjects and independent evaluators assessed both lips as improved. At all study visits, 72% to 93% of the subjects were satisfied with their lips and ≥96% reported that their lips had a natural look. Most AEs were mild-to-moderate local injection site reactions. Lip enhancement with this HA-based gel generated high subject satisfaction and natural-looking lips. The effect lasted for up to 9 months according to the GAIS ratings by subjects and independent evaluators. The product was well tolerated; most AEs were mild-to-moderate local injection site reactions.