A pharmacokinetic study of BBI-4000 gel in patients with primary focal hyperhidrosis in Japa
- Conditions
- Primary focal hyperhidrosis
- Registration Number
- JPRN-jRCT2071210041
- Lead Sponsor
- Yonemura Takuma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
1. Aged >=20 and <65 years at the time of consent
2. BMI >=18.0 and <30.0 at screening
3. Diagnosed as having primary focal hyperhidrosis in the screening interview
4. Hyperhidrosis disease severity scale (HDSS) of 3 or 4 at screening
1. Secondary hyperhidrosis
2. Whose hyperhidrosis symptoms started or worsened due to menopause
3. Indicated forthoracic sympathectomy
4. Identified with findings other than hyperhidrosis at or near the site of study drug administration on the day of admission at baseline
5. Diagnosed by the investigator /sub-investigator with a complication that can disrupt normal sweat production
6. Diagnosed by the investigator /sub-investigator with glaucoma, prostatic hypertrophy, or any other complications that can be exacerbated by using of anticholinergics.
7. Complicated with hyperallergic to anticholinergics or topical agents, or history thereof
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method