A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CB-03-01; Vehicle; CB-03-01
Intervention description: Topical cream, applied once a day; Topical cream, applied once or twice a day; Topical cream, applied twice a day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 363.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: acne; anti-androgen; clascoterone; cassiopea

Summary:

      CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent
      skin disorder. The purpose of this study is to compare the safety and efficacy of multiple
      concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or non-pregnant female. Females must be post-menopausal, surgically
             sterile or using highly effective birth control methods.

          -  Subject has provided written and verbal informed consent/assent.

          -  Subject has facial acne vulgaris (including the nose).

          -  Subject is willing to comply with study instructions and return to the clinic for
             required visits.

          -  Subject has used the same type and brand of make-up, other facial products (including
             cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at
             least one month prior to the study start and agrees to continue his/her other general
             skin and hair care products and regimen for the entire study.

        Exclusion Criteria:

          -  Subject is pregnant, lactating, or is planning to become pregnant during the study.

          -  Subject is currently enrolled in an investigational drug or device study.

          -  Subject has received an investigational drug or been treated with an investigational
             device within 30 days prior to the study start.

          -  Subject has the need or plans to be exposed to artificial tanning devices or excessive
             sunlight during the trial

          -  Subject has used any of the following topical anti-acne preparations or procedures on
             the face:

               -  Topical anti-acne treatments including but not limited to over-the-counter acne
                  cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based
                  products, corticosteroids and salicylic acid within two weeks of the initiation
                  of treatment.

               -  Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the
                  initiation of treatment.

               -  Light treatments, microdermabrasion or chemical peels within eight weeks of the
                  initiation of treatment.

          -  Subject has used the following systemic anti-acne medications:

               -  Corticosteroids (including intramuscular and intralesional injections) within
                  four weeks of the initiation of treatment. Inhaled, intranasal or ocular
                  corticosteroids are allowed if use is stable (stable use is defined as dose and
                  frequency unchanged for at least four weeks prior to the initiation of
                  treatment).

               -  Antibiotics within four weeks of the initiation of treatment with the exception
                  of five days or less of antibiotic therapy during this period, but with no
                  antibiotics use permitted within one week prior to the initiation of treatment.

               -  Spironolactone within eight weeks of the initiation of treatment with the
                  exception of five days or less of spironolactone therapy during this period, but
                  with no spironolactone use permitted within one week prior to the initiation of
                  treatment.

               -  Retinoid therapy within six months of the initiation of treatment.