2024-511047-26-01招募中4 期
DIFFUSION CHARACTERISTICS OF LETIBOTULINUMTOXIN A IN COMPARISON TO ONA AND ABO-BONTA
Hamburg University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月7日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum anhidrosis area; measured by the halo of anhidrosis
研究概览
简要总结
The aim of this study is to investigate the spread of three approved botulinum toxin type A preparations with and without complex-forming proteins by measuring and comparing the size of the anhidrotic halos they produce after injection of equivalent doses in an identical volume into the forehead of patients. The focus is on the comparison of letibotulinumtoxinA to onabotulinumtoxinA and abobotulinumtoxinA. In order to make an adequate change between different botulinum toxins possible, the diffusion surface of the toxins is of crucial importance.
研究设计
- 分配方式
- Randomized
- 主要目的
- Diffusion Characteristics Of Letibotulinumtoxin A In Comparison To Ona And Abo-bonta
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Stable health without uncontrolled systemic diseases •Fitzpatrick Skin Type I – VI •Age 18-75 •BMI of 16-27 kg/m2 •Healthy skin testing area •Uniform sweating activity and no areas of anhidrosis under standardized sweating conditions •Moderate to severe wrinkling (in motion) Scale: Forehead Line Rating Scale •Female subjects of childbearing potential must present a negative pregnancy test and commit to using a highly effective method of contraception during the study
排除标准
- •Asymmetrical forehead wrinkles • Active skin lesions/infections or irritations in the treatment area Past surgeries in the forehead area, including surgical removal of the corrugator, procerus or procerus or the supercilian depressor muscle, or a combination of these muscles, or scars in the forehead area, or such surgery is planned during the study • Prior dermal treatment of forehead within 6 months prior to inclusion Prior treatment (upper third of the face) with botulinum toxin of any serotype within 6 months prior to baseline, as well as botulinum toxin for any indication, except investigational drug during the study period • Known hypersensitivity to the study drug or its excipients • Any condition that could pose an increased risk to the subject due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, marked atrophy or weakness of the target muscles, or any other condition (at the discretion of the investigator) that could impair neuromuscular function or contraindicate botulinum toxin therapy.
结局指标
主要结局
Maximum anhidrosis area; measured by the halo of anhidrosis
Maximum anhidrosis area; measured by the halo of anhidrosis
次要结局
- Range of anhidrosis at all other measured time points; Wrinkle Thickness (No Movement / Maximum Tension) measured by Live Evaluation and Evaluation via Standardized Photography; Area under the curve (anhidrosis area) within a period of 6 months; Patient satisfaction; Eyebrow position
研究者
Clinical trial information desc
Scientific
Hamburg University
研究点 (1)
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