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An Exploratory, Multicenter, Investigator-blinded, Active-controlled Study to Investigate the Efficacy of Topical Azelaic Acid (AzA)15% Gel Twice Daily or Metronidazole Topical Gel 1% Once Daily, Plus Anti-inflammatory Dose Doxycycline (40mg) Once Daily in Subjects With Moderate Papulopustular Rosacea
Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.
Details
| Lead sponsor | LEO Pharma |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 207 |
| Start date | 2009-02 |
| Completion | 2009-07 |
Conditions
- Papulopustular Rosacea
Interventions
- Azelaic acid (Finacea, BAY39-6251)
- Metronidazole (Metrogel)
- Doxycycline (Oracea)
Primary outcomes
- Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward) — Baseline and Week 2
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Countries
United States