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

Skin safety study of KTZ-S 2% in Japanese healthy adult males -patch test and photopatch test-

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220345

Enrollment

Registered

2022-09-22

Start date

2022-09-15

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

Single 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 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

Design outcomes

Primary

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

Contacts

Public ContactShigeto Mashimo

Seren Pharmaceuticals Inc.

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

Outcome results

None listed

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