An open, randomized, prospective, comparative study of topical pimecrolimus 1% cream and topical ketoconazole 2% cream in the treatment of seborrheic dermatitis

Abstract

Background: Seborrheic dermatitis (SD) is a chronic inflammatory disorder that mainly affects the seborrheic region. While ketoconazole is often used, pimecrolimus has been used successfully in SD. Objective: To compare the efficacy and tolerability of pimecrolimus in comparison with ketoconazole in the treatment of SD. Methods: A total of 48 patients with SD were included in the study. Patients were randomized into two groups: 23 and 25 patients in the pimecrolimus and ketoconazole groups, respectively. Clinical measures were assessed by erythema, scaling and infiltration, which were evaluated using a four-point scale (0 to 3) at 2, 6, and 12 weeks. Results: Of these 48 patients, 38 completed the study (18 and 20 patients in the pimecrolimus and ketoconazole groups, respectively). The mean percentage decrease in clinical severity scores from baseline to the last follow-up period was 86.2% and 86.1% in the pimecrolimus and ketoconazole groups, respectively. Both pimecrolimus and ketoconazole were effective in SD. Differences between the two groups were not statistically significant. Side effects were observed more frequently with pimecrolimus than with ketoconazole and this difference was statistically significant. Conclusion: Our study showed that pimecrolimus had a comparable efficacy profile with that of ketoconazole, but side effects appeared more frequently in the pimecrolimus group than in the ketoconazole group.