Acne vulgaris
Conditions
Interventions
Single administration of CB-03-01 cream 1%
Sponsors
Toida Tsuneyuki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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).
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin safety: Skin Irritation Safety: Adverse events, laboratory tests and vital signs | — |
Contacts
Public ContactTomoe Yamanaka
Sun Pharma Japan Ltd.
Outcome results
None listed