Healthy men
Conditions
Interventions
Fifteen microL of SR-0379 (0, 0.02, 0.1, 0.25, 0.5%) is used for 48 hours closed patch test.
Sponsors
Osaka University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age: 20-40 years 2) BMI: 18.5-25.0 3) No abnormality in ECG and Blood pressure (under SBP 140mmHg and DBP 90mmHg) 4) Permission by doctors 5) Agreement of patients
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation by skin irritation score at pre-treatment, 1 or 24 hours after treatment (48 hour closed patch test) | — |
Countries
Japan
Contacts
Public ContactHisaya Ogura
Medical Corporation Shinanokai, Shinanozaka Clinic Management office
Outcome results
None listed