Status:
COMPLETED
Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea
Lead Sponsor:
LEO Pharma
Collaborating Sponsors:
Bayer
Conditions:
Papulopustular Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 topicall...
Detailed Description
The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center i...
Eligibility Criteria
Inclusion
- \- Moderate papulopustular rosacea (IGA\>4) with a minimum of 10 and no more than 50 inflammatory lesions and persistent erythema with or without telangiectasia
Exclusion
- Sensitivity to any of the treatments used
- Co-existing conditions that would unfavorably influence the course of the disease
- Pregnant or lactating women
- Severe rosacea
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00855595
Start Date
February 1 2009
End Date
July 1 2009
Last Update
March 31 2020
Active Locations (17)
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1
Birmingham, Alabama, United States, 35233
2
Denver, Colorado, United States, 80209
3
West Palm Beach, Florida, United States, 33401
4
Boston, Massachusetts, United States, 02114-2517