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

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

Author information

1
*DeNova Research, Chicago, Illinois; †Suzanne Bruce and Associates, PA, Houston, Texas; ‡Laser & Skin Surgery Center of Northern California, Sacramento, California; §SkinCare Physicians, Chestnut Hill, Massachusetts; ‖Image Dermatology, Montclair, New Jersey; ¶Society Hill Dermatology, Philadelphia, Pennsylvania; #Peloton Advantage, LLC, Parsippany, New Jersey; **Allergan plc, Irvine, California.

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.

PMID:
26618456
DOI:
10.1097/DSS.0000000000000540
[Indexed for MEDLINE]

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