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

• Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward) [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
  NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
  
  

• Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF) [ Time Frame: Week 2, 4, 6, 8 and 12 ] [ Designated as safety issue: No ]
  
• Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF) [ Time Frame: Baseline and Week 4, 6, 8 and 12 ] [ Designated as safety issue: No ]
  NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
  
  
• Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF) [ Time Frame: Baseline and Week 2, 4, 6, 8 and 12 ] [ Designated as safety issue: No ]
  NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
  
  
• 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) [ Time Frame: Baseline and Weeks 2, 4, 6, 8 and 12 ] [ Designated as safety issue: No ]
  
• Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF) [ Time Frame: Weeks 2, 4, 6, 8 and 12 ] [ Designated as safety issue: No ]
  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).
  
  
• Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF) [ Time Frame: Weeks 2, 4, 6, 8 and 12 ] [ Designated as safety issue: No ]
  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)
  
  
• Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2 [ Time Frame: At Week 2 ] [ Designated as safety issue: No ]
  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).
  
  
• Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4 [ Time Frame: At Week 4 ] [ Designated as safety issue: No ]
  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).
  
  
• Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6 [ Time Frame: At Week 6 ] [ Designated as safety issue: No ]
  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).
  
  
• Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8 [ Time Frame: At Week 8 ] [ Designated as safety issue: No ]
  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).
  
  
• Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12 [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
  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).
  
  
• Investigator Rating of Overall Improvement at End of Study (Week 12) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  
• Patient Rating of Overall Improvement at End of Study (Week 12) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  
• Patient Opinion of Cosmetic Acceptability at End of Study (Week 12) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  

• Patient Opinion of Local Tolerability [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  

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).