An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: cortexolone 17α-propionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Cassiopea; clascoterone; cortexolone 17α-propionate; anti-androgen; CB-01-03

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 subjects with acne vulgaris ages 12 years or older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has moderate to severe facial acne vulgaris as determined by the
             Investigator's Global Assessment (IGA) and obvious acne on the chest and/or back at
             study start.

          -  Subject has facial acne vulgaris (including the nose) with a minimum number of
             inflammatory lesions (papules, pustules, and nodules/cysts) and a minimum number of
             non-inflammatory lesions (open and closed comedones) at study start.

          -  Females must be post-menopausal, surgically sterile or using highly effective birth
             control methods with a negative urine pregnancy test (UPT) at study start.

          -  Subject must be in general good health in the opinion of the investigator, with normal
             renal function, based on screening physical examination, medical history, and clinical
             laboratory values.

        Exclusion Criteria:

          -  Subject is pregnant, lactating, or is planning to become pregnant during the study.

          -  Subject is 12-20 years of age and has a Body Mass Index (BMI) for age percentile >
             85%.

          -  Subject is > 20 years of age and has a BMI > 32.0 kg/m2.

          -  Subject has used tobacco, smoking cessation products, or products containing nicotine
             within three months prior to study start.

          -  Except for the use of contraceptives, subject has used any prescription drug or herbal
             product within 14 days prior to dosing, any non-prescription drug or vitamin or
             mineral supplements within 7 days prior to study start; any known enzyme-inducer,
             enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint
             solvents or pesticides within 30 days of study start.

          -  Subject has used topical anti-acne medications containing retinoids such as
             tazarotene, adapalene or tretinoin, within four weeks of study start.

          -  Subject has used the following systemic anti-acne medications: antibiotics within two
             weeks of study start, spironolactone within four weeks of study start, or retinoid
             therapy within three months of study start.

          -  Subject 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.

          -  Subject has the need or plans to be exposed to artificial tanning devices or excessive
             sunlight during the study.

          -  Subject has used light treatments, microdermabrasion or chemical peels to the face,
             chest and back within eight weeks of study start.

          -  Subject cannot avoid any type of strenuous exercise (swimming, running, team sports,
             etc.,) or the use of hot tubs/saunas from study start to the end of the study.

          -  Subject has received an investigational drug or been treated with an investigational
             device within 30 days prior to study start.

          -  Subject is currently enrolled in an investigational drug or device study.

          -  Subject has used topical corticosteroids (including inhaled and intranasal
             corticosteroids) within two weeks of study start.

          -  Subject has used systemic corticosteroids (including intramuscular and intralesional
             injections) within four weeks of study start.

          -  Subject has an irregular sleep schedule or works night shifts.

          -  Subject has experienced significant blood loss within 60 days or has donated plasma
             within 72 hours prior to study start.

          -  Subject tests positive at Screening for human immunodeficiency virus (HIV) or is known
             to be seropositive for HIV.

          -  Subject tests positive at Screening for hepatitis B surface antigen, hepatitis C
             antibody or has a history of a positive result.

          -  Subject had major surgery within 30 days prior to study start or plans to have surgery
             during the study.

          -  Subject has participated in a previous CB-03-01 study.