JPRN-jRCT2080223891已完成3 期
A confirmatory 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
- 281
研究概览
简要总结
The proportion of subjects achieving the primary endpoint was statistically significantly higher in the 5% group than in the 0% group (between-treatment difference: 17.5%, 95% confidence interval: 6.02-28.93, chi-square test: p = 0.003). All secondary endpoints showed improvement in the 5% group compared to the 0% group, with statistically significant differences between the treatment groups. Adverse events were generally mild, with no deaths, and no serious adverse events in the 5% group.
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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