Efficacy and Safety of RelabotulinumtoxinA Liquid Botulinum Toxin in the Treatment of Lateral Canthal Lines: Results From the Phase 3 READY-2 Study.

Autor:	Ablon G; Ablon Skin Institute and Research Center, Manhattan Beach, California., Bank D; The Center for Dermatology, Cosmetic & Laser Surgery, Mount Kisco, New York., Kontis TC; Facial Plastic Surgicenter, Baltimore, Maryland., Ibrahim SF; Rochester Dermatologic Surgery, Victor, New York., Palm M; Art of Skin MD, Solana Beach, California., Cox SE; Aesthetic Solutions, Chapel Hill, North Carolina., Rivers JK; Pacific Derm, Vancouver, British Columbia, Canada.; Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada., Grunebaum L; Siperstein Dermatology Group, Boynton Beach, Florida.; Division of Facial plastic and Reconstructive Surgery, Mayo Clinic, Phoenix, Arizona., Goldman MP; Cosmetic Laser Dermatology: A Platinum Dermatology Partners Company, San Diego, California., Humphrey S; Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada.; Humphrey Cosmetic Dermatology, Vancouver, British Columbia, Canada., Coquis-Knezek S; Galderma, Dallas, Texas.
Jazyk:	angličtina
Zdroj:	Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] [Dermatol Surg] 2024 Dec 18. Date of Electronic Publication: 2024 Dec 18.
DOI:	10.1097/DSS.0000000000004470
Abstrakt:	Background: RelabotulinumtoxinA (RelaBoNT-A) is a complex-free, ready-to-use, liquid botulinum toxin A. Objective: Efficacy/safety of RelaBoNT-A treatment for lateral canthal lines (LCL). Methods: Randomized adults received RelaBoNT-A (30 U/side; n = 230) or placebo (n = 73) during a 6-month, double-blind, Ph3 study (Relabotulinumtoxin Aesthetic Development Study-2 [READY-2]). Primary end points (Month 1, maximum smile) comprised: composite ≥2-grade responder rate using concurrent LCL severity investigator live assessment (LCL-ILA) and subject live assessment (LCL-SLA); LCL-ILA 0 (none)/1 (mild) responder rate. Subject satisfaction and adverse events were also reported. Results: Month 1 composite ≥2-grade responder rates were 51.8% (RelaBoNT-A) and 1.4% (placebo; (p < .001). Month 1 none/mild LCL-ILA responder rates were 87.2% (RelaBoNT-A) and 11.9% (placebo; p < .001). Onset was reported Day 1 by 34%. At Month 6, LCL-ILA responder rates for RelaBoNT-A remained at 23.3% (none/mild) and 35.9% (≥1-grade improvement). Median return to baseline severity was 24.7 weeks; 64% (RelaBoNT-A group) had not returned to baseline at Month 6. RelaBoNT-A satisfaction was high through Month 6 (71%). Mild/moderate treatment-related adverse events occurred in 6.1% (RelaBoNT-A) and 5.5% (placebo). Conclusion: RelaBoNT-A (60 U) treatment provided statistically significant improvement of moderate-to-severe LCL. One-third of subjects reported onset within 1 day and improvements were maintained through Month 6. Treatment satisfaction was high. RelaBoNT-A was well tolerated. (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.)
Databáze:	MEDLINE
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