Skin Safety Study of CB-03-01 Cream

JRCT ID: jRCT2071230110

Registered date:26/01/2024

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Acne vulgaris
• Date of first enrollment: 28/02/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Single administration of CB-03-01 cream 1%

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Male

Include criteria

-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).

Exclude criteria

-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.

Related Information

• Primary Sponsor: Toida Tsuneyuki