Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea

Phase 2 Completed 401 enrolled LEO Pharma Bayer · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2009-12
Primary completion: 2010-08
Completion: 2010-08

Outcome

Met primary endpoint

registry NUMBER Azelaic Acid Foam, 15% (BAY39-6251): 43.4 Percentage of participants NCT01025635 ↗

registry analysis (unspecified test); Azelaic Acid Foam, 15% (BAY39-6251) vs Vehicle Foam; p = 0.017; Cochran-Mantel-Haenszel NCT01025635 ↗

registry analysis (unspecified test); Azelaic Acid Foam, 15% (BAY39-6251) vs Vehicle Foam; p <0.001; ANCOVA NCT01025635 ↗

Publications

Background Draelos ZD, Elewski B, Staedtler G, Havlickova B. Azelaic acid foam 15% in the treatment of papulopustular rosacea: a randomized, double-blind, vehicle-controlled study. Cutis. 2013 Dec;92(6):306-17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azelaic acid	Small molecule	15 %	Topical