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NCT00855595 · ClinicalTrials.gov registry record · Phase 4
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
A Phase 4 study of Papulopustular Rosacea, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 4
- Development phase
- 207
- Enrollment target
- 17
- Study locations
NCT00855595: Completed Phase 4 study of Papulopustular Rosacea, sponsored by LEO Pharma.
NCT00855595 is a Phase 4 study of Papulopustular Rosacea that has completed, run by LEO Pharma. The registered enrollment target is 207 participants, below the 261-participant average among 11 other Papulopustular Rosacea trials with a reported enrollment target (21% lower). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00855595, a Phase 4 study of Papulopustular Rosacea, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 207 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)
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 |
What the finished NCT00855595 record still lists
NCT00855595 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 261-participant average among 11 other Papulopustular Rosacea trials with a reported enrollment target (21% lower).
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.
NCT00855595 lists 17 locations in 14 states (Texas, Alabama, Colorado).
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.
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).
Who is sponsoring clinical trial NCT00855595?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT00855595's enrollment target sits among peer trials
207 7th of 11 higher than 5 of 11 other Papulopustular Rosacea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Papulopustular Rosacea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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