Safety and Effectiveness of the Hyaluronic Acid Filler, HYC-24L, for Lip and Perioral Augmentation

Dermatol Surg. 2015 Dec;41 Suppl 1:S293-301. doi: 10.1097/DSS.0000000000000540.

Abstract

Background: Hyaluronic acid gels are increasingly used for augmentation of the lips.

Objective: To assess the safety and effectiveness of Juvéderm Ultra XC, a 24 mg/mL hyaluronic acid gel containing 0.3% (wt/wt) lidocaine (HYC-24L), for augmentation of the lips.

Methods: This ongoing, multicenter, single-blind study randomized 213 subjects to the treatment group (n = 157) or concurrent no-treatment control group that received delayed treatment (n = 56). The primary effectiveness endpoint was the responder rate (≥1 point improvement from baseline) based on the blinded evaluating investigator's assessment of the subject's overall lip fullness (or fullness of the eligible lip) using the validated Allergan 5-point Lip Fullness Scale. To meet this endpoint, the treatment group had to have a responder rate ≥60% and significantly greater than the treatment control group at Month 3.

Results: The primary endpoint was met, with a 79.1% responder rate for the treatment group and 26.1% for the treatment control group (p < 0.0001). More than half of subjects (56.4%) maintained treatment response for 12 months. Common injection site responses were swelling, bruising, and firmness; most were of mild or moderate severity.

Conclusion: HYC-24L is safe and effective for aesthetic lip augmentation, with results lasting up to 1 year.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Cosmetic Techniques
  • Dermal Fillers / administration & dosage*
  • Female
  • Follow-Up Studies
  • Humans
  • Hyaluronic Acid / administration & dosage*
  • Injections, Intradermal
  • Lip*
  • Male
  • Middle Aged
  • Patient Satisfaction*
  • Rejuvenation*
  • Single-Blind Method
  • Skin Aging / drug effects*
  • Young Adult

Substances

  • Dermal Fillers
  • Juvederm Ultra
  • Hyaluronic Acid