A confirmatory study of BBI-4000 gel
Phase 3
Completed
- Conditions
- Primary hyperhidrosis
- Registration Number
- JPRN-jRCT2080223891
- Lead Sponsor
- KAKEN PHARMACEUTICAL CO., LTD.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 281
Inclusion Criteria
Diagnosed as hyperhidrosis
Exclusion Criteria
Secondary hyperhidrosis
Experienced the first onset or worsening of hyperhidrosis associated with menopause
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>gravimetric sweat production<br>HDSS
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>gravimetric sweat production<br>HDSS<br>HDSM-Ax<br>DLQI