An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne, cortexolone, anti-androgen Read More

Inclusion Criteria:

• Patient must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide written informed consent for the patient.
• Patient has moderate to severe facial acne vulgaris as determined by the Investigator and obvious acne on the trunk (i.e., shoulders, upper chest, and/or back).
• Females of childbearing potential must be using highly effective birth control methods with a negative urine pregnancy test (UPT) at study start.
• Patient must be in general good health with normal renal function and no clinically relevant abnormalities present at study start.
• Patient and parent/guardian are able to communicate with the staff and are willing to comply with study instructions, reside at and/or return to the clinic for required visits.

Exclusion Criteria:

• Patient is pregnant, lactating, or is planning to become pregnant during the study.
• Patient has a Body Mass Index (BMI) for age percentile > 95%.
• Patient has any skin or medical condition, including facial hair that could interfere with the evaluation of the test article or requires the use of interfering topical or systemic therapy.
• Patient has received an investigational drug or been treated with an investigational device within 30 days prior to study start.
• Patient is currently enrolled in an investigational drug or device study.
• Patient has any condition which, in the investigator's opinion, would make it unsafe for the patient to participate in this research study.
• Patient has known allergy or sensitivity to CB-03-01 or any of its ingredients
• Patient has participated in a previous CB-03-01 study.