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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

NCT00855595 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2020-03-31

Study results available
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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.

Conditions

  • Papulopustular Rosacea

Interventions

DRUG

Azelaic acid (Finacea, BAY39-6251)

Participants received topical azelaic acid gel 15% twice daily for 12 weeks

DRUG

Metronidazole (Metrogel)

Participants received topical metronidazole 1% gel once daily for 12 weeks

DRUG

Doxycycline (Oracea)

Participants received systemic doxycycline 40 mg once daily for 12 week

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-04-30
Completion
2009-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00855595 on ClinicalTrials.gov