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Finacea Foam in papulopustular rosacea
NCT00617903Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2008
- Primary completion
- Jun 2008
- Countries
- 1
- Sponsor
- LEO Pharma
- Modality
- Small Molecules
- Conditions
- papulopustular rosacea
01
Overview
Phase 2, randomised, double-blind trial of azelaic acid 15% gel vehicle in papulopustular rosacea (2 arms), sponsored by LEO Pharma. Primary endpoints: Nominal Change From Baseline in Inflammatory Lesion Count at 12 weeks, Percentage of Participants With Investigator's Global Assessment Based Therapeutic Success at 12 weeks and 1 more. Started Jan 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Azelaic acid foam, 15%
Topical azelaic acid 15% foam twice daily for 12 weeks.
Vehicle foam
Topical vehicle foam twice daily for 12 weeks.
03
Who it enrols
Adults with papulopustular rosacea (10-50 papules/pustules) who have not recently used retinoids, antibiotics, or corticosteroids.
04
Endpoints
Primary
Nominal Change From Baseline in Inflammatory Lesion Count
Percentage of Participants With Investigator's Global Assessment Based Therapeutic Success
Grouped Change From Baseline in Erythema Intensity
Secondary
Mean of Inflammatory Lesion Count Per Participant
Percent Change From Baseline in Inflammatory Lesion Count
Percentage of Participants With Telangiectasia Intensity
Investigator's Rating of Overall Improvement
Patients' Rating of Overall Improvement
Patients' Opinion on Cosmetic Acceptability
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