A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of OSD-001 in primary palmar hyperhidrosis (Phase II study)
Phase 2
- Conditions
- Primary palmar hyperhidrosis
- Registration Number
- JPRN-UMIN000020647
- Lead Sponsor
- Osaka University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
1)Subjects who received a surgical treatment including the sympathetic nerve interception within 12 months prior to the study-entry . 2)Subjects who received a treatment with Sirolimus, Everolimus or Temsirolimus within 6 months prior to the study-entry. 3) Subjects who received a treatment with botulinum toxin within 12 months prior to the study-entry . 4) Subjects who received a treatment with aluminum chloride solution or iontophoresis within a month prior to the study-entry . 5) Subjects who received a treatment with anticholinergic drug or antihistamine drug within two weeks prior to the study-entry .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement ratio of palmar sweating after 8 weeks treatment
- Secondary Outcome Measures
Name Time Method 1) Improvement ratio of palmar sweating after 4 weeks treatment 2) Improvement ratio of HDSS score after 4 weeks or 8weeks treatment 3)improvement ratio of DLQI or CDLQI score after 4 weeks or 8 weeks treatment