1. A Phase-III Noninferiority, Randomized Controlled Trial of Letibotulinum Toxin A for the Improvement of Moderate-to-Severe Glabellar Wrinkles in China
- Author
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Yun Xie, MD, Xiumin Yang, MD, PhD, Hong Liang, MD, PhD, Hongliang Bo, MD, PhD, Jianyun Lu, MD, PhD, Qing Guo, MD, Li Li, MD, PhD, Hyoung-jin Moon, MD, and Qingfeng Li, MD, PhD
- Subjects
Surgery ,RD1-811 - Abstract
Background:. Letibotulinum toxin A has an established efficacy and safety profile for aesthetic treatment of glabellar wrinkles. This study was conducted to demonstrate the noninferiority of letibotulinum toxin A versus onabotulinum toxin A in improving the appearance of moderate-to-severe glabellar wrinkles in Chinese patients. Methods:. This phase-III multicenter, randomized, parallel positive control, double-blinded study compared the efficacy and safety of letibotulinum toxin A and onabotulinum toxin A. Eligible participants were randomized 3:1 to receive 20 U of letibotulinum toxin A or onabotulinum toxin A and were observed for 16 weeks postinjection. The primary endpoint was noninferiority in the proportion of study participants receiving a score of 0 or 1 for glabellar wrinkles on a four-point photographic evaluation scale, as assessed by an institution evaluator at maximum frown at week 4. Secondary endpoints included assessments at rest, photographic assessment of efficacy, and subjective self-assessment of the study participants. Results:. The proportion of participants (N = 500) receiving a score of 0 or 1 at maximum frown by the institution evaluator at week 4 was 88.49% for letibotulinum toxin A and 87.39% for onabotulinum toxin A (difference, 1.10%; 95% confidence interval, −5.02 to 8.82; P = 0.7469). No significant differences were observed between the treatments for secondary efficacy or safety endpoints. Participants’ self-assessment and satisfaction tended to be higher for letibotulinum toxin A than onabotulinum toxin A. Conclusion:. Letibotulinum toxin A is noninferior to onabotulinum toxin A in improving the appearance of moderate-to-severe glabellar wrinkles in Chinese patients.
- Published
- 2024
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