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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 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Azelaic acid (Finacea, BAY39-6251)
- DRUG Metronidazole (Metrogel)
- DRUG Doxycycline (Oracea)
Study Locations (17)
Texas
- — Austin
- — Dallas
- — Houston
- — San Antonio
Alabama
- — Birmingham
Colorado
- — Denver
Florida
- — West Palm Beach
Massachusetts
- — Boston
Michigan
- — Warren
Minnesota
- — Fridley
Nevada
- — Henderson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2009-02 |
| Est. Completion | 2009-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00855595
The ClinicalTrials.gov registry entry for NCT00855595 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LEO Pharma, which has 39 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Papulopustular Rosacea appearing as the primary indexed condition, and to 3 interventions — of which Azelaic acid (Finacea, BAY39-6251) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00855595 reports 17 study locations spanning 14 distinct geographic areas — top geographies include Texas, Alabama, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00855595 about?
NCT00855595 is a clinical study titled "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". 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 d...
What is the current status of trial NCT00855595?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 207 participants. The study started on 2009-02. Estimated completion is 2009-07.
What conditions does trial NCT00855595 study?
This clinical trial studies the following conditions: Papulopustular Rosacea. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00855595?
The interventions under investigation include: Azelaic acid (Finacea, BAY39-6251) (DRUG), Metronidazole (Metrogel) (DRUG), Doxycycline (Oracea) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00855595?
This trial is sponsored by LEO Pharma, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00855595 being conducted?
This trial has 17 study locations across Alabama, Colorado, Florida, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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