JPRN-jRCT2071210041已完成1 期
A pharmacokinetic study of BBI-4000 gel in patients with primary focal hyperhidrosis in Japan
Yonemura Takuma0 个研究点目标入组 24 人开始时间: 2021年7月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 65age old（—）
- 性别
- All
入选标准
- •1. Aged >=20 and <65 years at the time of consent
- •2. BMI >=18.0 and <30.0 at screening
- •3. Diagnosed as having primary focal hyperhidrosis in the screening interview
- •4. Hyperhidrosis disease severity scale (HDSS) of 3 or 4 at screening
排除标准
- •1. Secondary hyperhidrosis
- •2. Whose hyperhidrosis symptoms started or worsened due to menopause
- •3. Indicated forthoracic sympathectomy
- •4. Identified with findings other than hyperhidrosis at or near the site of study drug administration on the day of admission at baseline
- •5. Diagnosed by the investigator /sub-investigator with a complication that can disrupt normal sweat production
- •6. Diagnosed by the investigator /sub-investigator with glaucoma, prostatic hypertrophy, or any other complications that can be exacerbated by using of anticholinergics.
- •7. Complicated with hyperallergic to anticholinergics or topical agents, or history thereof
研究者
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