An Evaluation of the Adrenal Suppression Potential and PK of CB-03-01 Cream in Pediatric Patients With Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT02720627|
Recruitment Status : Completed
First Posted : March 28, 2016
Results First Posted : October 19, 2020
Last Update Posted : November 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: cortexolone 17α-propionate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Evaluation of the Adrenal Suppression Potential and Trough Plasma Concentrations of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects 9 to <12 Years of Age With Acne Vulgaris|
|Actual Study Start Date :||October 28, 2016|
|Actual Primary Completion Date :||March 21, 2018|
|Actual Study Completion Date :||March 21, 2018|
Experimental: CB-03-01 cream, 1%
Topical CB-03-01 (cortexolone 17α-propionate) cream containing 1% active drug applied to the face and trunk twice daily for 14 days
Drug: cortexolone 17α-propionate
CB-03-01 cream is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder.
Other Name: CB-03-01
- Change in HPA Axis Response as Measured by CST [ Time Frame: Pre- and Post-CST on Day 14 ]Measurement of serum cortisol concentrations after stimulation of the adrenal cortex with cosyntropin (Cosyntropin Stimulation Test - CST). HPA axis suppression is defined as a post-stimulation serum cortisol level ≤ 18 μg/dL at Day 14.
- Evaluate Trough Plasma Concentrations [ Time Frame: 14 Days ]Trough (single blood draw approximately 12 hours post the most recent dose) measurements of cortexolone 17α-propionate (clascoterone) concentration in plasma at Screening, Baseline, Day 7 and Day 14.
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): NCT02720627
|United States, Arkansas|
|Fort Smith, Arkansas, United States, 72916|
|United States, California|
|San Diego, California, United States, 92037|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Study Director:||R&D Department||Cassiopea SpA|