Patients experienced a progressive improvement in rosacea after treatment with a benzoyl peroxide formulation, according to results from an extension of two phase 3 trials presented at Maui Derm for Dermatologists.
“In a new microencapsulated formulation (E-BPO cream 5%), the drug is entrapped in silica microcapsules,” Neal Bhatia, MD, FAAD, and colleagues wrote in the poster. “This extends drug delivery time to improve efficacy and potently reduces the potential for skin irritation.”
Five hundred thirty-five patients (median age, 53 years; women, 71.4%) were included in the extension study; 172 patients previously received the vehicle in phase 3 trials, while 363 previously received treatment with the cream. Patients had moderate to severe rosacea and baseline Investigator’s Global Assessment score of 3 or 4, 15 to 70 inflammatory lesions, and two or fewer nodules. Outcome measures included IGA status of “clear or almost clear” at week 40, time to re-treatment, number of re-treatments and tolerability.
After 40 weeks of treatment, 67.2% of all patients (66.5% previously in vehicle group; 67.6% previously in benzoyl peroxide group) met the IGA efficacy outcome.
The median time to re-treatment was 58 days (95% CI, 57.0-64.0), with a mean number of 1.4 re-treatments.
The percentage of patients with no or mild erythema increased from 10.1% at baseline to 76.2% at 40 weeks, while the proportion of patients with no or mild telangiectasia increased from 58.2% to 80.1%.
Ninety-six patients reported a mild treatment-related adverse event, 81 reported a moderate event, and eight reported a serious event. Most were not thought to be related to the study treatment.
“The results from this long-term extension of two-phase 3 randomized controlled trials demonstrated progressive clinical improvement as reflected by the percentage of patients achieving IGA success and reduction in erythema as well as good cutaneous safety and tolerability with E-BPO cream 5% applied for up to 52 weeks in patients with rosacea,” the researchers wrote.
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