JPRN-jRCT2080223946已完成3 期
A long term safety study of BBI-4000 gel in patients with primary axillary hyperhidrosis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 185
研究概览
简要总结
The proportion of subjects with HDSS of 1 or 2 and a ratio of total axillary sweating weight less than or equal to 0.5 of the BBI-4000-06 baseline 3 at Week 52 after transition was 57.4% (54/94) in the 0%/5% group and 58.2% (53/91) in the 5%/5% group. The proportion of subjects with HDSS of 1 or 2 was generally similar after 6 weeks, and at 52 weeks, 76.6% (72/94) were in the 0%/5% group and 71.4% (65/91) were in the 5%/5% group.Adverse events were generally mild and there were no deaths.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 ot applicable(—)
- 性别
- All
入选标准
- •Diagnosed as hyperhidrosis
排除标准
- •Secondary hyperhidrosis
- •Experienced the first onset or worsening of hyperhidrosis associated with menopause
研究者
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