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

Dermatol Surg. 2015 Sep;41(9):1052-9. doi: 10.1097/DSS.0000000000000432.

Abstract

Background: A stabilized hyaluronic acid (HA)-based lidocaine-containing gel of nonanimal origin has been developed for lip enhancement.

Objective: To evaluate the efficacy, safety, and injection procedure of the HA gel in subjects seeking lip enhancement.

Methods: 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.

Results: 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.

Conclusion: 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.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Anesthetics, Local / therapeutic use
  • Biocompatible Materials / therapeutic use
  • Cosmetic Techniques*
  • Esthetics
  • Female
  • Gels
  • Humans
  • Hyaluronic Acid / therapeutic use*
  • Injections
  • Lidocaine / therapeutic use
  • Lip*
  • Middle Aged
  • Patient Safety
  • Patient Satisfaction
  • Retreatment
  • Surveys and Questionnaires

Substances

  • Anesthetics, Local
  • Biocompatible Materials
  • Gels
  • Hyaluronic Acid
  • Lidocaine