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

JRCT ID: jRCT2031230626

Registered date:08/02/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Rosacea
• Date of first enrollment: 28/03/2024
• Target sample size: 25
• Study type: Interventional
• Intervention(s): SKE-18, vehicle, and white petrolatum are applied.

Outcome(s)

• Primary Outcome: Safety

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 40age old
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kasumi Sanpei