Steven Dayan1, Suzanne Bruce, Suzanne Kilmer, Jeffrey S Dover, Jeanine B Downie, Susan C Taylor, Annette Skorupa, Diane K Murphy. 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) orconcurrent 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.
RCT Entities:
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.
Authors: Alexander Rivkin; Susan H Weinkle; Bhushan Hardas; Robert A Weiss; Dee Anna Glaser; Brian S Biesman; Andrew Schumacher; Diane K Murphy Journal: Aesthet Surg J Date: 2019-03-14 Impact factor: 4.283