Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cassiopea SpA
Age
9–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
