Randomized, phase 2, dose-ranging study in the treatment of rosacea with encapsulated benzoyl peroxide gel.

OBJECTIVE

Compare the safety and efficacy of 1% and 5% silica encapsulated benzoyl peroxide (E-BPO) in patients with papulopustular rosacea.

DESIGN

Multi-centered randomized, double blind, vehicle controlled parallel group, 12 week treatment in 92 patients with papulopustular rosacea. Primary endpoints were dichotomized IGA with success defined as clear/near clear and reduction in inflammatory lesions.

PATIENTS: 92 patients: 74% graded as moderate IGA, 14% severe and 12% mild. The mean inflammatory lesion count was 24.

INTERVENTION: Once daily treatment for 12 weeks with vehicle, 1% or 5% E-BPO.

RESULTS

1% and 5% E-BPO were superior to vehicle in reducing papulopustular lesions P =0.01 and P =0.02. 5% E-BPO was superior to vehicle for IGA P =0.0013.