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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 interaction. Investigator's Global Assessment (IGA) of papulopustular rosacea (static score): 0 - Clear (Virtually no rosacea ie, no papules and/or pustules; no or residual erythema; no or mild to moderate degree of telangiectasia may be present); 1 - Minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate degree of telangiectasia may be present); 2 - Mild (Few papules and/or pustules; mild erythema; mild to moderate degree of telangiectasia may be present); 3 - Mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate degree of telangiectasia may be present); 4 - Moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate degree of telangiectasia may be present); 5 - Moderate to severe (Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia may be present); 6 - Severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe degree of telangiectasia may be present).

Official Title
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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

Conditions
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Papulopustular Rosacea

Intervention / Treatment
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* Drug: Azelaic acid (Finacea, BAY39-6251)
* Drug: Metronidazole (Metrogel)
* Drug: Doxycycline (Oracea)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea)<br>Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks | Drug: Azelaic acid (Finacea, BAY39-6251)<br>* Participants received topical azelaic acid gel 15% twice daily for 12 weeks<br>Drug: Doxycycline (Oracea)<br>* Participants received systemic doxycycline 40 mg once daily for 12 week<br>|
| Active Comparator: Metronidazole (Metrogel) plus Doxycycline (Oracea)<br>Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks | Drug: Metronidazole (Metrogel)<br>* Participants received topical metronidazole 1% gel once daily for 12 weeks<br>Drug: Doxycycline (Oracea)<br>* Participants received systemic doxycycline 40 mg once daily for 12 week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward) | NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions) | Baseline and Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) |  | Week 2, 4, 6, 8 and 12 | 
| Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF) | NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions) | Baseline and Week 4, 6, 8 and 12 | 
| Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF) | NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions) | 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) |  | 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) | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1). | Weeks 2, 4, 6, 8 and 12 | 
| Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2) | Weeks 2, 4, 6, 8 and 12 | 
| Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information). | At Week 2 | 
| Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information). | At Week 4 | 
| Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information). | At Week 6 | 
| Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information). | At Week 8 | 
| Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information). | At Week 12 | 
| Investigator Rating of Overall Improvement at End of Study (Week 12) |  | Week 12 | 
| Patient Rating of Overall Improvement at End of Study (Week 12) |  | Week 12 | 
| Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) |  | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rosacea