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

LEO Pharma

Status and phase: Completed; Phase 4

Conditions: Papulopustular Rosacea

Treatments: Drug: Metronidazole (Metrogel); Drug: Azelaic acid (Finacea, BAY39-6251); Drug: Doxycycline (Oracea)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00855595

1402604 (Other Identifier)

256-0024 (Other Identifier)

14366

Details and patient eligibility

About

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.

Full 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).

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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207 participants in 2 patient groups

Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea)

Experimental group

Description:

Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks

Treatment:

Drug: Azelaic acid (Finacea, BAY39-6251)

Drug: Doxycycline (Oracea)

Metronidazole (Metrogel) plus Doxycycline (Oracea)

Active Comparator group

Description:

Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks

Treatment:

Drug: Metronidazole (Metrogel)

Drug: Doxycycline (Oracea)