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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
207
Participants received topical azelaic acid gel 15% twice daily for 12 weeks
Participants received topical metronidazole 1% gel once daily for 12 weeks
Participants received systemic doxycycline 40 mg once daily for 12 week
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
West Palm Beach, Florida, United States
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)
Time frame: Baseline and Week 2
Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: Weeks 2, 4, 6, 8 and 12
Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)
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Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Warren, Michigan, United States
Unnamed facility
Fridley, Minnesota, United States
Unnamed facility
Henderson, Nevada, United States
Unnamed facility
Albuquerque, New Mexico, United States
Unnamed facility
Stony Brook, New York, United States
Unnamed facility
Mason, Ohio, United States
...and 7 more locations
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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: At Week 12
Investigator Rating of Overall Improvement at End of Study (Week 12)
Time frame: Week 12
Patient Rating of Overall Improvement at End of Study (Week 12)
Time frame: Week 12
Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)
Time frame: Week 12