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

Phase 1

• Conditions: Rosacea

• Registration Number: JPRN-jRCT2031230626
• Lead Sponsor: Kasumi Sanpei

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-08
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 25

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety