跳至主要内容
临床试验/JPRN-jRCT2080223946
JPRN-jRCT2080223946已完成3 期

A long term safety study of BBI-4000 gel in patients with primary axillary hyperhidrosis

KAKEN PHARMACEUTICAL CO.,LTD.0 个研究点目标入组 185 人开始时间: 2018年6月15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
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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