Topical treatment of acne vulgaris with a combination of erythromycin 2% plus bifonazole 1% once daily compared to erythromycin 2% alone twice daily:a randomized, double-blind, controlled, clinical study

BACKGROUND: The mainstay of mild to moderate acne treatment is topical anti biotics. A new combination of 2% erythromycin and 1% bifonazole was tested in a double-blind trial against erythromycin alone. METHODS:A total of 207 acne patients were recruited into the study and 157 (76%) completed the full trial protocol of 12 weeks of treatment. In all, 7 4 patients applied the combination solution (erythromycin + bifonazole) onc e a day and 83 patients applied erythromycin solution twice a day. Outcome parameters measured were lesion-count (open and closed comedones, papules a nd pustules) and acne grading using the Cook's acne scale, carried out at t he initial visit, and at the 4, 8 and 12-week follow-up visits. RESULTS: Both treatment groups improved significantly over baseline and sho wed continuous improvement throughout the trial, with the erythromycin + bi fonazole group showing better improvement than the erythromycin group. At t he end of 12 weeks, open comedones, closed comedones, papules and pustules were reduced by 57%, 61%, 73% and 83% respectively in the erythromycin + bi fonazole group, compared to 47%, 60%, 61% and 72% in the erythromycin group (P-values of 0.04, 0.007, 0.0017 and 0.056, respectively). Acne grading im proved by 44.8% in the erythromycin + bifonazole group compared to a 34.7% improvement in the erythromycin group (P-values of 0.047). Transient local adverse effects occurred in both groups leading to five patients dropping o ut, four of them from the combination group. CONCLUSION: Topical treatment of acne with a combination of erythromycin 2% and bifonazole 1% once daily is a safe and effective treatment that has a modest but significant advantage over treatment with erythromycin 2% alone twice daily.