Skin safety study of KTZ-S 2% in Japanese healthy adult males

JRCT ID: jRCT2031220345

Registered date:22/09/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Seborrhoeic dermatitis capitis
• Date of first enrollment: 15/09/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Single administration of KTZ-S 2%

Outcome(s)

Primary Outcome

-Patch test outcomes:Skin irritation
-Photopatch test outcomes:Solar urticaria, Phototoxicity
-Safety outcomes:Adverse events, Side effects, Laboratory data

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 45age old
• Gender: Male

Include criteria

-Japanese healthy males between the age of 20 to under 45 years
-Those who the BMI between 18.5 to under 25.0

Exclude 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

Related Information

• Primary Sponsor: Takazawa Kenji