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Cortexolone 17α-Propionate HPA Axis and PK Study in Acne Vulgaris
NCT01831960Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2013
- Primary completion
- Nov 2013
- Countries
- 1
- Sponsor
- Intrepid Therapeutics, Inc.
- Modality
- Orthosteric Ligands
- Drugs
- clascoterone
- Conditions
- acne vulgaris
01
Overview
Phase 2, open-label, single-arm trial of clascoterone in acne vulgaris, sponsored by Intrepid Therapeutics, Inc. Primary endpoints: Change in HPA Axis Response to Cosyntropin at Day 14, PK Profiles (Cmax) of Cortexolone 17α-propionate at Day 14 and 2 more. Started Apr 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Cortexolone 17α-Propionate
Winlevi 1% cream applied every 12 hours
03
Who it enrols
Patients 12 years or older with moderate to severe facial acne vulgaris. Exclusion for BMI > 85th percentile (ages 12-20) or > 32 kg/m2 (ages > 20).
04
Endpoints
Primary
Change in HPA Axis Response to Cosyntropin
PK Profiles (Cmax) of Cortexolone 17α-propionate
PK Profiles (AUC) of Cortexolone 17α-propionate
PK Profiles (Cavg) of Cortexolone 17α-propionate
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