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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230012

Enrollment

Registered

2023-04-07

Start date

2023-04-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seborrhoeic dermatitis capitis

Interventions

5 days repeated administration of KTZ-S 2%

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion 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

Design outcomes

Primary

Measure	Time frame
-Pharmacokinetic outcomes:Blood drug level -Safety outcomes:Observation of targeted parts, Adverse events	—

Contacts

Public ContactMashimo Shigeto

Seren Pharmaceuticals Inc.

mashimo@serenpharma.com+81-3-5244-9343

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026