Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Papulopustular Rosacea in Elderly Patients: Post-hoc Analysis of Results from Two Randomized, Phase III, Vehicle-controlled Trials.

Objective: We sought to compare the efficacy and safety of encapsulated benzoyl peroxide (E-BPO) cream, 5%, versus vehicle in subjects <65 years of age versus subjects ≥65 with moderate to severe papulopustular rosacea. Methods: This analysis used pooled results from two 12-week, randomized, vehicle-controlled Phase III trials (NCT03564119, NCT03448939) of E-BPO cream, 5%. These trials included 733 subjects randomized 2:1 to E-BPO or vehicle. The primary endpoints were success in the Investigator's Global Assessment (IGA) score and reduction in mean inflammatory lesion count at Week 12. Results: Our analysis shows that E-BPO cream, 5%, was significantly superior to vehicle in achieving IGA success and reducing inflammatory lesions in both age groups. IGA success was achieved in 48.3% of subjects who received E-BPO versus 25.4% for vehicle in the intent-to-treat population. The E-BPO and vehicle IGA success percentages for subjects <65 were 45.7% and 23.8%, respectively, and those for subjects ≥65 were 60.0% and 28.1%, respectively. The absolute reduction from baseline in inflammatory lesions was -19.3 for subjects who received E-BPO versus -11.4 for those who received vehicle. The E-BPO and vehicle absolute reduction values for subjects <65 were -19.6 and -11.2, respectively, and 17.5 and -10.4 for subjects ≥65. There were no significant differences in the frequencies of adverse events or cutaneous tolerability. Limitations: E-BPO was not compared to nonencapsulated BPO. Conclusion: This combined analysis of results from the two Phase III, randomized, double-blind controlled studies of E-BPO cream, 5%, showed it was efficacious, tolerable, and safe, regardless of age.