NCT02565732已完成2 期
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Primary Axillary Hyperhidrosis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Gravimetry
研究概览
简要总结
This is a safety and efficacy study of botulinum toxin type A in subjects with primary axillary hyperhidrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary axillary hyperhidrosis
- •Female or male, 18 years of age or older in good general health
- •Excessive sweating interferes with daily life activities and scores 3 or 4 on the HDSS at Screening and Baseline
- •Axillary sweat production of at least 50 mg/5 min measured gravimetrically
排除标准
- •Any neurological condition, that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and Myasthenia gravis
- •Muscle weakness or paralysis, particularly in the upper extremities
- •Active skin disease or irritation or disrupted barrier at the treatment area
- •Undergone any procedures which may affect the axillary areas
- •Treatment with botulinum toxin type A in the axilla in the last 9 months or anywhere in the body in the last 6 months
- •Any prior axillary use of an anti-hyperhidrosis medical device
- •If menopausal had symptoms of menopause such as sweating or flushing within the last year
研究组 & 干预措施
Dose C
Placebo Comparator
Placebo comparator
干预措施: Placebo comparator (Biological)
Dose A
Experimental
Botulinum toxin type A
干预措施: Botulinum toxin type A (Biological)
Dose B
Experimental
Botulinum toxin type A
干预措施: Botulinum toxin type A (Biological)
结局指标
主要结局
Gravimetry
时间窗: Week 4
The amount of sweat measured gravimetrically
Hyperhidrosis Disease Severity Scale (HDSS)
时间窗: Week 4
Improvement at follow-up in the experimental groups compared to the placebo group
次要结局
- Dermatology Life Quality Index (DLQI)(Week 4)
研究者
研究点 (1)
Loading locations...
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