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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- LEO Pharma
- Enrollment
- 207
- Primary Endpoint
- Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea)
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
Intervention: Azelaic acid (Finacea, BAY39-6251) (Drug)
Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea)
Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
Intervention: Doxycycline (Oracea) (Drug)
Metronidazole (Metrogel) plus Doxycycline (Oracea)
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
Intervention: Metronidazole (Metrogel) (Drug)
Metronidazole (Metrogel) plus Doxycycline (Oracea)
Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
Intervention: Doxycycline (Oracea) (Drug)
Outcomes
Primary Outcomes
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
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
Secondary Outcomes
- 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)(Baseline and Week 4, 6, 8 and 12)
- Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)(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)(Weeks 2, 4, 6, 8 and 12)
- Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)(Weeks 2, 4, 6, 8 and 12)
- Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2(At Week 2)
- Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4(At Week 4)
- Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6(At Week 6)
- Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8(At Week 8)
- Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12(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)