An Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of CB-03-01 Cream in Subjects With Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT01831960|
Recruitment Status : Completed
First Posted : April 15, 2013
Results First Posted : November 17, 2020
Last Update Posted : December 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: cortexolone 17α-propionate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every Twelve Hours for Two Weeks in Subjects With Acne Vulgaris|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Experimental: Cortexolone 17α-Propionate
Topical cream, 1.0% concentration, applied every twelve hours
Drug: cortexolone 17α-propionate
- Change in HPA Axis Response to Cosyntropin [ Time Frame: Baseline and Day 14 ]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.
- PK Profiles (Cmax) of Cortexolone 17α-propionate [ Time Frame: Baseline and Day 14 ]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).
- PK Profiles (AUC) of Cortexolone 17α-propionate [ Time Frame: Baseline and Day 14 ]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]).
- PK Profiles (Cavg) of Cortexolone 17α-propionate [ Time Frame: Baseline and Day 14 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831960
|United States, Idaho|
|Northwest Clinical Trials, Inc.|
|Boise, Idaho, United States|
|United States, Indiana|
|Shideler Clinical Research Center|
|Carmel, Indiana, United States|
|United States, Michigan|
|Michigan Center for Research Corp.|
|Clinton Township, Michigan, United States|
|Study Director:||R&D Cassiopea||Cassiopea S.p.A.|