Trial Condition(s):
Papulopustular Rosacea
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
Bayer Identifier:
14366
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- 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 Criteria
- 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Kenneth R. Beer, MD, PA West Palm Beach, United States, 33401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Center for Skin Research Houston, United States, 77056 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations James Del Rosso, DO Henderson, United States, 89052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Univeristy of Alabama at Birmingham Birmingham, United States, 35233 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Grekin Skin Institute Warren, United States, 48088 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations DermResearch, Inc. Austin, United States, 78759 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Minnesota Clinical Study Center Fridley, United States, 55432 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations (CURTIS) Mass General Women’s Hospitals Harvard Medical School Boston , United States, 02114-2517 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Progressive Clinical Research San Antonio, United States, 78229 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cherry Creek Research, Inc. Denver, United States, 80209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oregon Medical Research Center, PC Portland, United States, 97223 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Baylor Research Institute Dallas, United States, 75246 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations David M. Pariser, MD Norfolk, United States, 23507 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations DermResearch Center of New York Stony Brook, United States, 11790 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dermatology Research Center, Inc Salt Lake City, United States, 84124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jan Fu, MD Mason, United States, 45040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Eduardo Tschen, MD Albuquerque, United States, 87106 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Nominal change from Baseline in inflammatory lesion (IL) count (sum of papules and pustules) at Week 2 (LOCF: last observation carried forward)Timeframe: Baseline and Week 2
Secondary Outcome
- Number of inflammatory lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)Timeframe: Week 2, 4, 6, 8 and 12
- Nominal change from Baseline in IL count at Weeks 4, 6, 8 and 12 (LOCF)Timeframe: Baseline and Week 4, 6, 8 and 12
- Percent change from Baseline in IL count at Weeks 2, 4, 6, 8 and 12 (LOCF)Timeframe: Baseline and Week 2, 4, 6, 8 and 12
- Percentage of participants with at least a 25%, 50%, or 75% improvement in facial IL counts from Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)Timeframe: Baseline and Weeks 2, 4, 6, 8 and 12
- Percentage of participants with Investigator’s Global Assessment (IGA) based therapeutic success at Weeks 2, 4, 6, 8 and 12 (LOCF)Timeframe: Weeks 2, 4, 6, 8 and 12
- Percentage of participants with IGA based patient response at Weeks 2, 4, 6, 8 and 12 (LOCF)Timeframe: Weeks 2, 4, 6, 8 and 12
- Percentage of participants with respective disease severity measured by IGA scores at Week 2Timeframe: At Week 2
- Percentage of participants with respective disease severity measured by IGA scores at Week 4Timeframe: At Week 4
- Percentage of participants with respective disease severity measured by IGA scores at Week 6Timeframe: At Week 6
- Percentage of participants with respective disease severity measured by IGA scores at Week 8Timeframe: At Week 8
- Percentage of participants with respective disease severity measured by IGA scores at Week 12Timeframe: At Week 12
- Investigator rating of overall improvement at end of study (Week 12)Timeframe: Week 12
- Patient rating of overall improvement at end of study (Week 12)Timeframe: Week 12
- Patient opinion of cosmetic acceptability at end of study (Week 12)Timeframe: Week 12
Additional Information
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