Diffusion Characteristics and Efficacy of Letibotulinum Toxin A in Forehead Wrinkle Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area of Anhidrosis
研究概览
简要总结
The goal of this clinical trial is to learn if letibotulinum toxin A is effective and safe for treating moderate-to-severe horizontal forehead wrinkles in adults. It will also compare its diffusion characteristics with two other botulinum toxin A products. The main questions it aims to answer are:
- Does letibotulinum toxin A reduce forehead wrinkles as effectively as other botulinum toxin A products?
- Does letibotulinum toxin A show more localized (smaller) diffusion after injection?
Researchers will compare letibotulinum toxin A with prabotulinum toxin A and onabotulinum toxin A (Botox®) to evaluate their diffusion profiles and wrinkle-reduction effects.
Participants will:
- Receive botulinum toxin A injections on each side of the forehead (split-face design)
- Undergo wrinkle assessments and sweat gland function testing using 3D imaging and iodine-starch tests
- Return to the clinic 2 weeks after treatment for follow-up evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
盲法说明
The allocation of treatment to the left or right side of the forehead was determined according to the randomization schedule and was concealed from both the investigators administering the treatment and the evaluators conducting outcome assessments, thereby maintaining a double-blind protocol throughout the study period.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants were eligible if they were aged ≥20 years with visible horizontal forehead wrinkles scored as moderate to severe on the Facial Wrinkle Scale using a photonumeric guide
排除标准
- •Exclusion criteria included a history of BoNT-A injection or cosmetic procedures near the fore-head/orbital area within the past year; signs of infection or inflammation at the injection site; compen-satory frontal hyperactivity; neuromuscular disorders including myasthenia gravis or amyotrophic lateral sclerosis; use of anticoagulants, aminoglycosides, curare-like agents, or neuromuscular inhibitors (stable doses of muscle relaxants or benzodiazepines are permitted); and hypersensitivity to the inves-tigational product or iodine.
研究组 & 干预措施
Treatment arm A
The first treatment group received letibotulinum toxin A (Botulax) on one randomly assigned side of their face and prabotulinum toxin A (Nabota) on the other side of their face.
干预措施: Letibotulinum toxin A (Drug)
Treatment arm A
The first treatment group received letibotulinum toxin A (Botulax) on one randomly assigned side of their face and prabotulinum toxin A (Nabota) on the other side of their face.
干预措施: Prabotulinum toxin A (Drug)
Treatment arm B
The first treatment group received letibotulinum toxin A (Botulax) on one randomly assigned side of their face and onabotulinum toxin A (Botox) on the other side of their face.
干预措施: Letibotulinum toxin A (Drug)
Treatment arm B
The first treatment group received letibotulinum toxin A (Botulax) on one randomly assigned side of their face and onabotulinum toxin A (Botox) on the other side of their face.
干预措施: Onabotulinum toxin A (Drug)
结局指标
主要结局
Area of Anhidrosis
时间窗: 2 weeks post-injection
The area of anhidrosis (sweat suppression) at each injection site will be measured using the Minor iodine-starch test to evaluate diffusion characteristics of botulinum toxin A formulations. The test is conducted under controlled temperature and humidity. Image-based quantification will be used to calculate the diffusion area in cm².
次要结局
- Wrinkle Improvement(Baseline and 2 weeks post-treatment)