Real-World Efficacy of Azelaic Acid 15% Gel for the Reduction of Inflammatory Lesions of Rosacea

Paul J. Wirth, MD; Meagan-Helen Henderson Berg; Neil Sadick, MD, FAAD, FAACS, FACP, FACPh


Skin Therapy Letter. 2017;22(6):5-7. 

In This Article


Data regarding the effectiveness of therapeutics is typically derived from rigorously administered, randomized, controlled phase 3 trials for FDA approval. While these studies are essential to document the efficacy of topical drugs, it is not always possible to predict the therapeutic benefits of a topical treatment used in the real-world setting.

Azelaic acid 15% gel resulted in a significant reduction in inflammatory lesion counts after 4 weeks of treatment in this study, and IGA scores showed clear improvement in the majority of patients. The effectiveness of azelaic acid 15% gel increases as treatment duration increases. Most patients reported that they had experienced improvement, with none reporting worsening of their condition since the start of the study.

The main limitations of this study were the small sample size, the short study duration, and a single center trial. Further investigations will be needed to observe the long-term efficacy and safety of azelaic acid 15% gel. Additional work is needed to determine patient preference and changes in quality of life associated with use of azelaic acid 15% gel. Future directions may also include real-world effectiveness of azelaic acid 15% gel applied once daily and when used in combination with other agents such as metronidazole.