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A Phase I, skin safety study with SKE-18 1% cream in healthy Japanese participants

A Phase I, skin safety study with SKE-18 1% cream in healthy Japanese participants

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031230626
Enrollment
25
Registered
2024-02-08
Start date
2024-03-28
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

Rosacea

Interventions

SKE-18, vehicle, and white petrolatum are applied.

Sponsors

Kasumi Sanpei
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adult males aged 18 to 40 years at the time of signing the Informed Consent Form 2. Subjects with BMI (body mass index) of >= 18.5 to < 25.0 at screening 3. Subjects who are considered by the investigator as acceptable for inclusion in the study as judged from the results of observation and inspection upon screening and admission 4. Subjects who received full explanations regarding the objective of the study, details of the study and the study drug and provided voluntary written informed consent

Exclusion criteria

Exclusion criteria: 1. Subject with a medical history of drug allergy 2. Subjects with a medical history of food allergy 3. Subjects with a medical history (heart, liver, kidney, lung, blood diseases, etc.) that is considered ineligible for the study 4. Subjects with a medical history of contact dermatitis, such as adhesive tape dermatitis, or mechanical urticaria 5. Subjects with a medical history of photosensitivity 6. Subjects considered ineligible for the study by the investigator

Design outcomes

Primary

MeasureTime frame
Safety

Contacts

Public ContactClinical Trials Information Desk

Sato Pharmaceutical Co., Ltd.

clinicaltrials-info@sato-seiyaku.co.jp+81-3-5412-7329

Outcome results

None listed

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