A randomized double-blind parallel-group study compared the efficacy and tolerability of 0.05% and 0.1% isotretinoin cream with placebo cream base in 82 patients with mild to moderate facial acne vulgaris. The effects of treatment were assessed by acne grade and lesion count according to the method of Burke and Cunliffe. Significant reductions in acne grade after 4, 8 and 12 weeks were observed in both active treatment groups with the most pronounced improvement in whiteheads (P<0.01). The overall tolerability of the treatment was good to excellent in 79.2% of patients using 0.1% isotretinoin cream and in 73.1% using 0.05% cream.