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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Northwest Clinical Trials, Inc.
Boise, Idaho, United States
Shideler Clinical Research Center
Carmel, Indiana, United States
Michigan Center for Research Corp.
Clinton Township, Michigan, United States
Change in HPA Axis Response to Cosyntropin
Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin injection (Cosyntropin Stimulation Test - CST). Prior to CST, a pre-CST blood sample is taken between 7AM to 9AM. Thirty minutes after CST, a post-CST blood sample is collected. HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14.
Time frame: Baseline and Day 14
PK Profiles (Cmax) of Cortexolone 17α-propionate
Max concentration (Cmax) of cortexolone 17α-propionate in plasma following the first application (i.e., Day 1, 0-12 hours) and last application (i.e., Day 14, 0-12 hours).
Time frame: Baseline and Day 14
PK Profiles (AUC) of Cortexolone 17α-propionate
Area under the plasma concentration curve (0-12 hours) of cortexolone 17α-propionate at baseline (i.e., Day 1, after first application \[0-12 hours\]) and at Day 14 (i.e., Day 14, after last application \[0-12 hours\]).
Time frame: Baseline and Day 14
PK Profiles (Cavg) of Cortexolone 17α-propionate
Average concentration of cortexolone 17α-propionate in plasma calculated as the ratio of the AUC(0-12 hours) and the dosing interval (i.e., 12 hours) at baseline (i.e., Day 1, after first application) and at Day 14 (after last application).
Time frame: Baseline and Day 14
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