A long term safety study of BBI-4000 gel
Phase 3
Completed
- Conditions
- Primary hyperhidrosis
- Registration Number
- JPRN-jRCT2080223946
- Lead Sponsor
- KAKEN PHARMACEUTICAL CO.,LTD.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 185
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>Adverse events
- Secondary Outcome Measures
Name Time Method efficacy<br>Gravimetric sweat production<br>HDSS<br>HDSM-Ax<br>DLQI