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Winlevi in facial acne vulgaris
NCT02608476Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2015
- Primary completion
- Feb 2018
- Countries
- 6
- Sponsor
- Cassiopea S.p.A.
- Modality
- Orthosteric Ligands
- Drugs
- clascoterone
- Conditions
- acne vulgaris
01
Overview
Phase 3, randomised, double-blind trial in acne vulgaris comparing Winlevi with Vehicle (2 arms). Primary endpoints: Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA) at 12 weeks, Change From Baseline in Non-inflammatory Lesion (NIL) Counts at 12 weeks and 1 more. Started Nov 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Winlevi
CB-03-01 cream, 1% applied twice daily
Vehicle
Vehicle cream applied twice daily
03
Who it enrols
Patients 9+ with moderate to severe facial acne vulgaris (IGA 3-4), 30-75 inflammatory lesions, 30-100 non-inflammatory lesions. Excludes nodulocystic acne or >2 nodules.
04
Endpoints
Primary
Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
Change From Baseline in Non-inflammatory Lesion (NIL) Counts
Change From Baseline in Inflammatory Lesion (IL) Counts
Secondary
Change From Baseline in Total Lesion Counts
Percent Change From Baseline in Total Lesion Counts
Percent Change From Baseline in Non-inflammatory Lesion Counts
Percent Change From Baseline in Inflammatory Lesion Counts
05
Results
Primary endpoints met
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