NCT01799824已完成2 期
Clinical Trial to Evaluate ANT-1403 in the Treatment of Primary Axillary Hyperhidrosis in Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 9
- 主要终点
- HDSS
研究概览
简要总结
The purpose of this study is to confirm the effect of ANT-1403 in the treatment of 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 18 - 70 years of age
- •diagnosis of moderate to severe primary axillary hyperhidrosis
- •≥50 mg of sweat production/axilla in 5 minutes as measured gravimetrically
- •HDSS score of ≥3
排除标准
- •diagnosis of secondary hyperhidrosis
- •skin affliction in the axilla requiring medical treatment
- •20% aluminum hydrochloride, e.g. Drysol®, in 2 weeks prior of Baseline
- •oral anticholinergic treatment
- •botulinum toxin treatment in the prior 9 months
- •history of surgery for axillary hyperhidrosis
- •present or history of neuromuscular disease
- •female subjects who are pregnant or are nursing a child
结局指标
主要结局
HDSS
时间窗: Week 8
次要结局
- GSP(Week 8)
研究者
研究点 (9)
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