Clinical trial NCT00855595: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Papulopustular Rosacea
Keywords: Rosacea
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2009-03-04
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)
timeFrame: Baseline and Week 2
Secondary outcomes:
measure: Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
timeFrame: Week 2, 4, 6, 8 and 12
measure: Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)
timeFrame: Baseline and Week 4, 6, 8 and 12
measure: Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)
timeFrame: Baseline and Week 2, 4, 6, 8 and 12
measure: 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)
timeFrame: Baseline and Weeks 2, 4, 6, 8 and 12
measure: Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)
timeFrame: Weeks 2, 4, 6, 8 and 12
measure: Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)
timeFrame: Weeks 2, 4, 6, 8 and 12
measure: Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2
timeFrame: At Week 2
measure: Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4
timeFrame: At Week 4
measure: Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6
timeFrame: At Week 6
measure: Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8
timeFrame: At Week 8
measure: Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12
timeFrame: At Week 12
measure: Investigator Rating of Overall Improvement at End of Study (Week 12)
timeFrame: Week 12
measure: Patient Rating of Overall Improvement at End of Study (Week 12)
timeFrame: Week 12
measure: Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)
timeFrame: Week 12
Other outcomes:
measure: Patient Opinion of Local Tolerability
timeFrame: Week 12
Locations:
city: Birmingham
country: United States
state: Alabama
city: Denver
country: United States
state: Colorado
city: West Palm Beach
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
city: Warren
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Henderson
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Stony Brook
country: United States
state: New York
city: Mason
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Del Rosso JQ, Bruce S, Jarratt M, Menter A, Staedtler G. Efficacy of topical azelaic acid (AzA) gel 15% plus oral doxycycline 40 mg versus metronidazole gel 1% plus oral doxycycline 40 mg in mild-to-moderate papulopustular rosacea. J Drugs Dermatol. 2010 Jun;9(6):607-13.