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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 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.

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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.

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

FieldValue
Enrollment Target 207 participants
Start Date 2009-02
Est. Completion 2009-07
Phase Phase 4

Sponsor

LEO Pharma

65 total trials

What the Registry Record Tells You About NCT00855595

The ClinicalTrials.gov registry entry for NCT00855595 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 11 other Papulopustular Rosacea trials with a reported enrollment target (21% lower). The listed sponsor is LEO Pharma, which has 65 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.