Bayer HealthCare has announced positive results from a Phase III trial that evaluated its 15% azelaic acid (AzA) foam formulation for the topical treatment of inflammatory papules and pustules of rosacea.
The randomized, double-blind, vehicle-controlled, multi-center study included more than 960 adult patients with rosacea, showing 12-50 inflammatory lesions at the time of inclusion in the study. The severity of the condition was based on Investigator Global Assessment (IGA) scale scoring as well as a count of the inflammatory lesions.
Patients were randomized in a 1:1 ratio to receive either AzA 15% foam or unmedicated vehicle foam twice daily for 12 weeks. Safety and tolerability were evaluated during the full 16-week study course, while the efficacy endpoints were assessed at the end of the 12-week treatment period.
Compared to vehicle, treatment with AzA 15% foam resulted in a higher clinician-assessed treatment success rate (32.0% vs. 23.5%, p=0.001) as well as statistically significant greater reduction in the mean nominal change of inflammatory lesions (-13.0 vs. -10.2, p<0.001).
The overall frequency of adverse events (AEs) was 31% in the AzA 15% foam group and 25% in the vehicle group. The vast majority of AEs in both groups were mild to moderate. In the AzA 15% foam group, no severe drug-related and no serious drug-related AEs were reported. Overall, less than 2% of subjects discontinued treatment due to an AE, the frequency being slightly lower in the AzA 15% foam group.