跳至主要内容
临床试验/JPRN-jRCT2080223891
JPRN-jRCT2080223891已完成3 期

A confirmatory study of BBI-4000 gel in patients with primary axillary hyperhidrosis

KAKEN PHARMACEUTICAL CO., LTD.0 个研究点目标入组 281 人开始时间: 2018年5月7日最近更新:
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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