A Multicentre, Double-Blind, Parallel-Group Study to Evaluate 3% Erythromycin/5% Benzoyl Peroxide Dual-Pouch Pack for Acne Vulgaris

Objective The combination of erythromycin and benzoyl peroxide has proven to be a well-tolerated and effective topical treatment for acne vulgaris. A novel 3% erythromycin/5% benzoyl peroxide formulation provides a single unit-dose of erythromycin and benzoyl peroxide from a dual-pouch package and eliminates the need for pharmacist compounding and refrigeration. This study assessed the tolerability and efficacy of this formulation in patients with acne vulgaris. Design and patients Multicentre, randomised study in 223 patients with moderate to moderately severe acne who received 3% erythromycin/5% benzoyl peroxide via the dual-pouch package or matching vehicle control for 8 weeks. Results Active treatment was significantly more effective than vehicle control in reducing total number of acne lesions (31.9 and 23.1, respectively; p = 0.004) and the percentage reduction of inflammatory acne lesions (69.2 and 48.1%, respectively; p = 0.001) from baseline to week 8. Statistical significance for these parameters was observed within 2 weeks and continued to study endpoint. At week 8, treatment success was demonstrated in a significantly greater proportion of patients in the active treatment group (34.8%) compared with the vehicle control group (14.4%; p < 0.001). No treatment-related serious adverse events were reported. The most common adverse event was dry skin, which occurred in 12.5 and 5.4% of patients administered active treatment or vehicle, respectively. Conclusion This novel formulation was demonstrated to be well tolerated and effective in the treatment of acne vulgaris. The 3% erythromycin/5% benzoyl peroxide dual-pouch pack is an alternative to the currently marketed topical gel for patients with moderate to moderately severe acne vulgaris. This combination antimicrobial product provides an innovative unit-dose delivery system and offers the consumer more convenience by eliminating the need for pharmacist compounding and refrigeration.