Skin safety study of KTZ-S 2% in Japanese healthy adult males
Phase 1
- Conditions
- Seborrhoeic dermatitis capitis
- Registration Number
- JPRN-jRCT2031220345
- Lead Sponsor
- Takazawa Kenji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
Japanese healthy males between the age of 20 to under 45 years
-Those who the BMI between 18.5 to under 25.0
Exclusion Criteria
-Those with medical history of ketoconazole sensitivity
-Those with medical history of drug allergy
-Those with medical history of photosensitivity
-Those with medical history of skin cancer
-Those with medical history of contact dermatitis, mechanical urticaria, etc.
-Those with skin symptoms (including sun barn) or skin disease of targeted parts (back) or systematic disease which will be effected to the evaluation of this study
-Those with receiving topical or systemic treatments that may affect the evaluation of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Patch test outcomes:Skin irritation<br>-Photopatch test outcomes:Solar urticaria, Phototoxicity<br>-Safety outcomes:Adverse events, Side effects, Laboratory data
- Secondary Outcome Measures
Name Time Method