Randomized, placebo-controlled, double-blind study on clinical efficacy of ciclopiroxolamine 1% cream in facial seborrhoeic dermatitis

Abstract

Background Antifungal agents are beneficial in the treatment of seborrhoeic dermatitis. Objectives To perform a randomized, vehicle‐controlled, double‐blind clinical study with an antifungal ciclopiroxolamine (CIC) 1% cream in patients with mild‐to‐moderate seborrhoeic dermatitis of the face. Methods One hundred and twenty‐nine patients were enrolled, 57 patients in the CIC group and 72 patients in the vehicle group, and comprised the study population for efficacy (intent‐to‐treat analysis) and safety. Patients were randomly allocated to apply either the CIC cream or the vehicle on their facial lesions, twice daily for a maximum of 28 days (initial phase), followed by a once daily application of the test products for another 28 days (maintenance phase). Test lesions were defined as lesions localized in the nasolabial folds and/or the eyebrow. The main efficacy parameter (end‐point) was the proportion of patients who achieved complete disappearance of erythema and scaling (treatment responders) at the end of the initial phase (28 days or less) and of the maintenance phase (28 days). Results At baseline, both treatment groups were comparable in terms of demographic data and lesional status. At the end of the initial phase, responders to treatment were higher with CIC (25 patients, 44%) than with the vehicle (11 patients, 15%) (P < 0·001, Fisher exact test). At the end of the maintenance phase, responders in both groups were even higher, comprising 27 patients (63%, n = 43) in the CIC group and 15 patients (34%, n = 44) in the vehicle group (P < 0·007, intergroup analysis). The local tolerance was good in the two groups, except for a higher rate of lesional exacerbation in the vehicle group. No drug‐related systemic adverse event was observed during the study. Conclusions CIC administered in a cream demonstrated a good therapeutic value in mild‐to‐moderate seborrhoeic dermatitis of the face.