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

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.