Investigator-Reported Efficacy of Azelaic Acid Foam 15% in Patients With Papulopustular Rosacea: Secondary Efficacy Outcomes From a Randomized, Controlled, Double-blind, Phase 3 Trial
Papulopustular rosacea (PPR) is characterized by centrofacial papules and pustules commonly associated with erythema. To compare investigator-reported efficacy outcomes for azelaic acid (AzA) foam 15% versus vehicle foam in PPR, a randomized, vehicle-controlled, double-blind phase 3 clinical trial was conducted at 48 US sites. Participants received AzA foam or vehicle foam for 12 weeks. Secondary efficacy outcomes included change in inflammatory lesion count (ILC), therapeutic response rate according to investigator global assessment (IGA), and change in erythema rating. This study was comprised of 961 participants with PPR. The results support the therapeutic superiority of AzA foam over vehicle foam.
Practice Points
- Papulopustular rosacea (PPR) is a common chronic inflammatory dermatosis.
- A novel hydrophilic foam formulation of azelaic acid (AzA) was approved for the treatment of PPR.
- In addition to effectively treating papules and pustules, AzA foam also may reduce rosacea-associated erythema.
- The unique AzA foam vehicle may improve epidermal barrier integrity and function, thereby offering patients a distinct topical approach to rosacea management.
Conclusion
Azelaic acid foam 15% combines a well-established treatment of PPR with new vehicle technology to deliver effective therapy across multiple disease dimensions. In addition, the vehicle foam appears to demonstrate inherent therapeutic properties independent of AzA. The availability of this novel, efficacious, and well-tolerated option for PPR has the potential to improve patient care, reduce disease burden, and minimize unnecessary costs through increased tolerability and compliance.21
Acknowledgment
Editorial support through inVentiv Medical Communications (New York, New York) was provided by Bayer Pharmaceuticals.
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