Skin irritation study using SR-0379 (Patch test)
- Conditions
- Healthy men
- Registration Number
- JPRN-UMIN000015391
- Lead Sponsor
- Osaka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 20
Not provided
1) drug allergy 2) atopy or tape-sensitive skin 3) inflammation, dermatitis or injury etc. in back skin 4) Burn or tatoo in the back skin 5) history of tape-sensitive dermatitis 6) other severe disease history (liver, kidney, lung and blood diseases) 7) heart failure and ischemic heart disease, and history of these diseases 8) history of heavy alcohol drunker or drug user 9) the patients who cannot stop alcohol or smoking during clinical trial 10) the patients with blood donation (400 mL for 90 days or 200 mL for 14 days) 11) the patients with drug usage for 14 days 12) the patients who attend other clinical trial for 90 days 13) the patients with the abnormal findings in blood immune response and urinary test 14) inappropriate patients judged by doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation by skin irritation score at pre-treatment, 1 or 24 hours after treatment (48 hour closed patch test)
- Secondary Outcome Measures
Name Time Method