A double-blind, placebo-controlled trial of a ciclopirox olamine 1% shampoo for the treatment of scalp seborrheic dermatitis

BACKGROUND: Ciclopirox olamine is a broad spectrum antifungal agent that has been shown to be effective in treating various cutaneous fungal infections. However, little information is available on the effect of ciclopirox olamine on seborrheic dermatitis, a common skin disorder associated with increased cutaneous fungal density. AIM: The purpose of the study was to determine the effectiveness and safety of 1% ciclopirox olamine shampoo for the treatment of scalp seborrheic dermatitis. METHODS: The study was designed as a prospective, double-blind, randomized, placebo-controlled clinical study and was performed in the dermatology institute of Clalit Health Services, southern district, Israel. Patients were randomly divided into a ciclopirox olamine shampoo treatment group and a placebo (vehicle) shampoo treatment group. The shampoo was applied twice a week, 5 min for each application (after first shampooing and rinsing the hair). Patients were treated for a period of 4 weeks and examined on enrollment, after 2 weeks, after 4 weeks tend of treatment) and at the end of 6 weeks (follow-up examination). The main outcome measures were severity of seborrheic dermatitis symptoms and the overall assessment of response to treatment by both the physician and patient. RESULTS: Of the 102 patients enrolled in the study, 82 patients completed the full trial protocol. A total of 93% of the patients in the ciclopirox olamine group improved or cleared compared with 41% of the patients in the placebo group at the end of 4 weeks of treatment (P < 0.00001). There were no significant side-effects during treatment and no recurrence was observed 2 weeks after cessation of treatment. Comparison of severity scores showed a significant reduction (at a significantly higher rate) in scalp seborrheic dermatitis symptoms in the ciclopirox group com pared with the placebo group and compared with baseline scores. CONCLUSION: We conclude that 1% ciclopirox olamine shampoo is an effective and safe treatment of scalp seborrheic dermatitis.