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A dose-finding study of azithromycin in the treatment of acne vulgaris.

This open, multicenter, comparative, randomized study included 120 subjects with papulopustular stage of acne vulgaris. Subjects were randomized to one of the three treatment groups (A, total dose 4.5 g of azithromycin in 7 weeks; B, total dose 6.0 g in 10 weeks; and C, total dose 7.5 g in 13 weeks). The aim was to identify the optimum azithromycin dose in the treatment of acne vulgaris through monitoring the efficacy and safety of three dosage regimens. Clinical efficacy was assessed upon completion of study therapy and six months of therapy initiation. Post-therapeutic efficacy assessment was available in 104 subjects. The difference between three treatment groups was most pronounced in the "cure" category (36.11% in group A, 58.82% in group B and 55.88% in group C) and "failure" category (8.33% in group A, and no failures in groups B and C). Follow up efficacy assessment was available in 87 subjects. The group percentage of "cure" was lower and group percentage of "treatment failure" higher in group A than in groups B and C. Azithromycin in a total dose of 6.0 g in 10 weeks seems to be a promising agent in the treatment of papulopustular acne vulgaris with few side effects and good patient compliance.