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 ha s been shown to be effective in treating various cutaneous fungal infection s. However, little information is available on the effect of ciclopirox ola mine on seborrheic dermatitis, a common skin disorder associated with incre ased 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 der matitis. METHODS: The study was designed as a prospective, double-blind, randomized, placebo-controlled clinical study and was performed in the dermatology ins titute of Clalit Health Services, southern district, Israel. Patients were randomly divided into a ciclopirox olamine shampoo treatment group and a pl acebo (vehicle) shampoo treatment group. The shampoo was applied twice a we ek, 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 seborr heic dermatitis symptoms and the overall assessment of response to treatmen t by both the physician and patient. RESULTS: Of the 102 patients enrolled in the study, 82 patients completed t he full trial protocol. A total of 93% of the patients in the ciclopirox ol amine group improved or cleared compared with 41% of the patients in the pl acebo 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 gro up and compared with baseline scores. CONCLUSION: We conclude that 1% ciclopirox olamine shampoo is an effective and safe treatment of scalp seborrheic dermatitis.