an evaluation of the adrenal suppression potential and pharmacokinetic properties of cb-03-01 cream in subjects with acne vulgaris

Conditions: Acne Vulgaris

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.

Keywords: cassiopea clascoterone cortexolone 17α-propionate anti-androgen cb-01-03