CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 207 enrolled
Drug / intervention
Azelaic acid (Finacea, BAY39-6251) +2 moredrug
Likely dose
Doxycycline (Oracea) 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00855595
NCT00855595Phase 4Completed

An Exploratory, Multicenter, Investigator-blinded, Active-controlled Study to Investigate the Efficacy of Topical Azelaic Acid (AzA)15% Gel Twice Daily or Metronidazole Topical Gel 1% Once Daily, Plus Anti-inflammatory Dose Doxycycline (40mg) Once Daily in Subjects With Moderate Papulopustular Rosacea

LEO Pharma·interventional·Posted Mar 4, 2009·Updated Mar 31, 2020

In Brief

A Phase 4 clinical trial evaluating Azelaic acid (Finacea, BAY39-6251), Metronidazole (Metrogel), and 1 other intervention for Papulopustular Rosacea. Completed, enrolled 207 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 4, 2009
Enrollment StartFeb 1, 2009
Primary CompletionApr 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.3 years ago

Interventions

Azelaic acid (Finacea, BAY39-6251)drug

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

Metronidazole (Metrogel)drug

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

Doxycycline (Oracea)drug

Participants received systemic doxycycline 40 mg once daily for 12 week