An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: cortexolone 17α-propionate
Intervention description: CB-03-01 cream is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 9 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: acne; cortexolone; anti-androgen

Summary:

      This study is designed to determine the hypothalamic-pituitary-adrenal (HPA) axis suppression
      potential and pharmacokinetic (PK) properties of CB-03-01 Cream, 1%, applied every twelve
      hours for two weeks, in pediatric patients 9 to less than 12 years of age with acne vulgaris.
      Adrenal suppression effects and systemic safety are an important safety concern. The current
      study is designed to investigate these potential concerns under maximal use conditions.
    

Eligibility criteria:

        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.