Two posters were presented at the Fall Clinical meeting describing the clinical trails of encapsulated benzoyl peroxide (E-BPO) for the treatment of rosacea. E-BPO is an innovative formulation of BPO that utilizes Sol-Gel microencapsulation technology to enclose BPO in silica microcapsules, resulting in BPO that is gradually released from the microcapsules onto the skin. As seen in the two 12-week, Phase 3 studies, E-BPO is an efficacious and well-tolerated treatment for rosacea. Because rosacea is a chronic disease, the safety and tolerability of E-BPO was further evaluated for up to a 40 week extension for a maximum of 52 weeks in an open-label extension study, and E-BPO showed a favorable tolerability and safety profile.

CRITICAL EVALUATION OF BENZOYL PEROXIDE IN ROSACEA: OLD CHALLENGES AND NEW CLINICAL OPPORTUNITIES WITH ENCAPSULATED BENZOYL PEROXIDE

The efficacy, safety, and tolerability of encapsulated benzoyl peroxide (E-BPO), a topical indicated for the treatment of rosacea, was evaluated in 2 randomized, placebo-controlled, double-blind, parallel, 12-week, Phase 3 clinical trials. A total of 733 adults with moderate to severe rosacea were enrolled in the trial and randomized 2:1 to E-BPO cream, 5%, or vehicle. The primary endpoints were the percentage of subjects who achieved investigator global assessment (IGA) success (defined as achieving an IGA rating of “clear” or “almost clear”) at week 12 and the absolute change in inflammatory lesion count from baseline to week 12. For both primary endpoints, E-BPO was significantly superior to vehicle. After 12 weeks in Study 1, the percentage of subjects who achieved an IGA score of clear or almost clear was 43.5% for E-BPO cream, 5%, and 16.1% for vehicle. In Study 2, the respective values were 50.1% and 25.9%. The change in lesion count from baseline to week 12 was –17.4 for E-BPO cream, 5%, versus –9.5 for vehicle in Study 1, and –20.3 and –13.3 (all P<.001) for Study 2. There were no serious adverse events (AEs) associated with E-BPO cream, 5%, with 1.8% of subjects in the E-BPO cream, 5%, group and 0.4% of subjects in the vehicle group discontinuing due to AEs. Local tolerability was also assessed, and the mean tolerability stayed below a score of 1 (on a 0–3 scale) for both E-BPO cream, 5%, and vehicle. Results from the 2 Phase 3 trials indicated that a 12-week regimen of once-daily E-BPO cream, 5%, was efficacious, safe, and well tolerated in subjects with rosacea.¹

ENCAPSULATED BENZOYL PEROXIDE (E-BPO): A NOVEL FORMULATION OF BPO FOR LONG-TERM MANAGEMENT OF ROSACEA

To assess the long-term safety of E-BPO cream, 5%, all subjects from the 2 Phase 3 trials were given the opportunity to continue in the open-label extension study for up to an additional 40 weeks, for a total of up to 52 weeks of daily treatment with E-BPO cream, 5%. For subjects with an IGA score of “mild” to “severe,” E-BPO cream, 5%, was applied daily and was stopped when subjects achieved “clear” or “almost clear.” The cutaneous safety and local tolerability assessment demonstrated that E-BPO cream, 5%, when used for up to 52 weeks, was generally safe and well tolerated. Four subjects (0.7%) discontinued the study due to AEs. Of the 185 treatment-emergent AEs reported, 17 (3.2%) were deemed related to study drug by the investigator. For subjects enrolled in the extension, the mean number of retreatments was 1.4, which was defined as the number of times a subject’s IGA score went from an IGA score of “clear” or “almost clear” to “mild,” “moderate,” or “severe” and E-BPO cream, 5%, was dispensed for daily application.²

References: 

1. Del Rosso JQ, Bhatia ND, Baldwin H, Stein Gold L, Desai SR, Brantman S. Critical evaluation of benzoyl peroxide in rosacea: Old challenges and new clinical opportunities with encapsulated benzoyl peroxide. Poster presented at: Fall Clinical; October 20-23, 2022; Las Vegas, NV.

2. Bhatia ND, Lain E, Baldwin H, Brantman S, Del Rosso JQ, Sivamani RK. Encapsulated benzoyl peroxide (E-BPO): A novel formulation of BPO for long-term management of rosacea. Poster presented at: Fall Clinical; October 20-23, 2022; Las Vegas, NV.

Microencapsulation technology is licensed from Sol-Gel Technologies.