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Olumacostat Glasaretil in Acne Vulgaris (CLAREOS-2)
NCT03073486Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2017
- Primary completion
- Dec 2017
- Countries
- 3
- Sponsor
- Dermira, Inc.
- Modality
- Small Molecules
- Conditions
- acne vulgaris
01
Overview
Phase 3, randomised, double-blind trial in acne vulgaris comparing Olumacostat Glasaretil Gel, 5.0% with Vehicle (2 arms). Primary endpoints: Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12, Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 and 1 more. Started Feb 2017; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Olumacostat Glasaretil Gel, 5.0%
Active drug applied twice daily
Vehicle
Placebo gel applied twice daily
03
Who it enrols
Patients aged 9 and older with facial acne vulgaris defined by at least 20 inflammatory and 20 non-inflammatory lesions and an IGA score of 3 or greater.
04
Endpoints
Primary
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12
05
Results
Not all primary endpoints met
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