Phase 4 N=207 Randomized Single-blind Treatment

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

Papulopustular Rosacea

Bottom Line

View on ClinicalTrials.gov: NCT00855595 ↗

Enrolled (actual)

207

Serious AEs

0.5%

Results posted

Aug 2012

Primary outcome: Primary: Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward) — -10.5; -9.4 Inflammatory lesions — p=0.0903

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Azelaic acid (Finacea, BAY39-6251) (Drug); Metronidazole (Metrogel) (Drug); Doxycycline (Oracea) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: LEO Pharma
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)	-10.5; -9.4	0.0903
SECONDARY Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)	10.1; 12.5; 7.4; 9.5; 5.9; 7.8	—
SECONDARY Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)	-13.2; -12.4; -14.8; -14.1; -15.5; -15.6	—
SECONDARY Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)	-50.7; -43.0; -64.9; -56.9; -72.4; -64.5	—
SECONDARY 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)	84.9; 77.2; 61.3; 47.5; 20.8; 17.8	—
SECONDARY Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)	13.2; 7.9; 32.1; 26.7; 45.3; 27.7	—
SECONDARY Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)	32.1; 27.7; 55.7; 44.6; 60.4; 53.5	—
SECONDARY Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2	0.9; 1.0; 12.3; 6.9; 18.9; 19.8	—
SECONDARY Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4	7.5; 6.9; 24.5; 19.8; 23.6; 17.8	—
SECONDARY Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6	18.9; 9.9; 26.4; 17.8; 15.1; 25.7	—
SECONDARY Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8	18.9; 13.9; 32.1; 25.7; 21.7; 19.8	—
SECONDARY Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12	30.2; 22.8; 32.1; 29.7; 16.0; 19.8	—
SECONDARY Investigator Rating of Overall Improvement at End of Study (Week 12)	46.6; 42.3; 35.9; 34.0; 12.6; 17.5	—
SECONDARY Patient Rating of Overall Improvement at End of Study (Week 12)	51.0; 49.0; 39.2; 33.3; 7.8; 15.6	—
SECONDARY Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)	52.0; 56.3; 34.3; 26.0; 4.9; 8.3	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT00855595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.