Microencapsulated benzoyl peroxide (E-BPO) 5% cream is superior to vehicle in reducing inflammatory lesions in patients with papulopustular rosacea, with E-BPO demonstrating favorable tolerability and safety, according to study results presented at the 2023 Annual Meeting of the American Academy of Dermatology (AAD), held from March 17 to 21, 2023, in New Orleans, Louisiana.
The novel E-BPO 5% cream, which is approved for use in adults for the treatment of inflammatory lesions associated with rosacea, “traps” BPO in silicone microcapsules, effectively extending the drug delivery time and minimizing the risk for irritation. According to the researchers, silica shells are responsible for controlling the rate of drug release onto the skin, allowing for the therapeutic effect of BPO while mitigating side effects associated with traditional formulations.
The new E-BPO 5% cream formulation is designed to be used alone as a topical treatment for rosacea as well as in combination with the prescription retinoid therapy tretinoin for the treatment of acne vulgaris.
A team of researchers evaluated the safety, tolerability, and efficacy of once-daily E-BPO 5% cream in 2 phase 3 studies of patients with papulopustular rosacea (n=733). In these 12-week studies, the researchers observed that E-BPO 5% cream featured a rapid onset of action, with more than 40% reduction of inflammatory lesions observed at week 2 in treated patients.
Additionally, a significantly greater proportion of patients who received the E-BPO 5% cream were rated clear/almost clear on Investigators Global Assessment compared with patients treated with vehicle (study 1: 43.5% vs 16.1%, respectively; study 2: 50.1% vs 25.9%; P <.001 for all). In studies 1 and 2, change in absolute lesion counts was -17.4 with the E-BPO cream vs -9.5 with vehicle and -20.3 with the E-BPO cream vs -13.3 with vehicle, respectively (P <.001 for all).
The mean cutaneous tolerability parameters of dryness, itching, scaling, and stinging/burning were consistently less than 1 on a scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe) and were not statistically significantly different between active treatment and vehicle. The reported treatment-emergent adverse events (AEs) associated E-BPO 5% cream were mild or moderate in intensity. The AEs associated with treatment that occurred in more than 1% of patients were edema, erythema, pain, and pruritus, all of which occurred at the application site.
Furthermore, in a long-term extension phase 3 clinical study of 547 patients, E-BPO 5% cream was well tolerated over a span of 54 weeks. Most patients (>95%) reported tolerability scores of “mild” or “none,” and there were no new safety signals associated with the E-BPO 5% cream.
Benzoyl peroxide “has a long history of use in dermatologic diseases but was historically limited by irritation,” the researchers said, concluding that the E-BPO 5% cream “improves clinical outcomes for patients with rosacea by effectively reducing inflammatory lesions with good tolerability and a favorable safety profile.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Baldwin H, Elewski B, Levy-Hacham O, et al. Evolution of benzoyl peroxide: microencapsulated 5% cream to improve tolerability in papulopustular rosacea. Presented at: American Academy of Dermatology (AAD) 2023 Annual Meeting; March 17-21, 2023. Poster 41694.