臨床研究等提出・公開システム

Skin Safety Study of CB-03-01 Cream in Healthy Volunteers

Skin Safety Study of CB-03-01 Cream

Toida Tsuneyuki

Sun Pharma Japan Ltd.

8-9-5, Nishigotanda, Shinagawa-ku, Tokyo

JPS.clinicaltrial@sunpharma.com

Yamanaka Tomoe

Sun Pharma Japan Ltd.

8-9-5, Nishigotanda, Shinagawa-ku, Tokyo

+81-3-5719-6663

JPS.clinicaltrial@sunpharma.com

Complete

Feb. 13, 2024

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

-Who are able to understand and comply with the content of the study, and whose written informed consent has been obtained by when any study-related procedures begin.
-Aged 18 to < 65 years old (at informed consent).
-Body mass index (BMI) is 18.5 kg/m2 or more and less than 25.0 kg/m2 (at screening tests).

-Individuals with a medical history or complications including liver disease, renal disease, heart and other cardiovascular diseases, digestive disease, blood disease, and skin disease ,etc, which are considered inappropriate for participation in the study.
-Individuals with a medical history or complications of contact dermatitis including tape dermatitis, and mechanical urticaria.
-Individuals with a medical history or complications of skin hypersensitivity to topical agents, cosmetic, or quasi-drugs.
-Individuals with a medical history or complications of hypersensitivity to CB-03-01 or its components.
-Individuals with abnormal findings (e.g., eczema/dermatitis, dyschromatosis, inflammation by sunburn, wounds injury, and scars) on the planned application site of the study drug (at screening and prior to the study drug application on Day 1).
-Individuals who used any drugs (and/or vaccines) including over-the-counter drugs within 7 days prior to the study drug application or who need to use any drugs (and/or vaccines) including over-the-counter drugs during the study period.
-Individuals who the Investigator considers ineligible to be subjects.

Male

Acne vulgaris

Single administration of CB-03-01 cream 1%

Skin safety: Skin Irritation
Safety: Adverse events, laboratory tests and vital signs

+81-92-283-7701

Feb. 08, 2024

No

none