An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cre… (NCT01831960) | Clinical Trial Compass
CompletedPhase 2
An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris
United States42 participantsStarted 2013-04
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pa…