Conditions: Papulopustular Rosacea
Keywords: Rosacea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 207
Healthy volunteers: no

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 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:
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).

Arms:
arm 1: Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks arm 2: Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks

Interventions: intervention 1: Azelaic acid (Finacea, BAY39-6251) intervention 2: Metronidazole (Metrogel) intervention 3: Doxycycline (Oracea)
Intervention descriptions: intervention 1: Participants received topical azelaic acid gel 15% twice daily for 12 weeks intervention 2: Participants received topical metronidazole 1% gel once daily for 12 weeks intervention 3: Participants received systemic doxycycline 40 mg once daily for 12 week

Protocol document: