Phase 1 repeated administration study of KTZ-S 2% in Japanese healthy adult males

JRCT ID: jRCT2031230012

Registered date:07/04/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Seborrhoeic dermatitis capitis
• Date of first enrollment: 15/04/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): 5 days repeated administration of KTZ-S 2%

Outcome(s)

Primary Outcome

-Pharmacokinetic outcomes:Blood drug level
-Safety outcomes:Observation of targeted parts, Adverse events

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 skin symptoms or skin disease of targeted parts (head) 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: Kenji Takazawa