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BACKGROUND: The mainstay of mild to moderate acne treatment is topical antibiotics. 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, 74 patients applied the combination solution (erythromycin + bifonazole) once a day and 83 patients applied erythromycin solution twice a day. Outcome parameters measured were lesion-count (open and closed comedones, papules and pustules) and acne grading using the Cook's acne scale, carried out at the initial visit, and at the 4, 8 and 12-week follow-up visits. RESULTS: Both treatment groups improved significantly over baseline and showed continuous improvement throughout the trial, with the erythromycin + bifonazole group showing better improvement than the erythromycin group. At the end of 12 weeks, open comedones, closed comedones, papules and pustules were reduced by 57%, 61%, 73% and 83% respectively in the erythromycin + bifonazole 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 improved 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 out, 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. (J Dermatol Treat (2000) 11: 247-251). [ABSTRACT FROM AUTHOR]