CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 401 enrolled
Drug / intervention
Azelaic acid foam 15% +1 moredrug
Likely dose
Not stated in 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/NCT01025635
NCT01025635Phase 2Completed

Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Study to Investigate Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily in Subjects With Papulopustular Rosacea

LEO Pharma·interventional·Posted Dec 3, 2009·Updated Mar 31, 2020

In Brief

A Phase 2 clinical trial evaluating Azelaic acid foam 15% and Vehicle foam for Papulopustular Rosacea. Completed, enrolled 401 participants across 20 sites.

Detailed Summary

This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 3, 2009
Enrollment StartDec 1, 2009
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.6 years ago

Interventions

Azelaic acid foam 15%drug

Applied topically twice daily for 12 weeks

Vehicle foamdrug

Applied topically twice daily for 12 weeks