Randomized, Open-Labeled, Non-Inferiority Study between Ciclopiroxolamine 1% Cream and Ketoconazole 2% Foaming Gel in Mild to Moderate Facial Seborrheic Dermatitis

Abstract

Background: Topical ketoconazole (KC) is considered a standard treatment for seborrheic dermatitis. In a placebo-controlled, double-blind clinical study, we demonstrated that antifungal ciclopiroxolamine (CIC) 1% cream was effective in mild to moderate facial seborrheic dermatitis. Objectives: We report here the results of a randomized, open-labeled clinical study comparing CIC 1% cream and KC 2% foaming gel in patients with mild to moderate facial seborrheic dermatitis, using a non-inferiority trial design. Methods: Three hundred and three patients were enrolled, 154 patients in the CIC group and 149 patients in the KC group, and comprised the study population for intent-to-treat (ITT) analysis. The per protocol (PP) population comprised a total of 282 patients, 147 in the CIC group and 135 in the KC group. Patients were randomly allocated to apply either the CIC 1% cream twice a day for 28 days maximum (initial phase), followed by once a day for another 28 days (maintenance phase); or the KC 2% foaming gel twice a week at the initial phase, followed by once a week during the maintenance phase. Test lesions were defined as lesions localized to the nasolabial folds, alae nasi, and/or the eyebrows. The main efficacy parameter (endpoint) was the proportion of patients who presented a complete disappearance of both erythema and scaling on test lesions and pruritus on all lesions at the end of the initial phase (28 days or less). Results: At baseline, both treatment groups were comparable in terms of demographic data and lesional status. At the end of the initial phase, responders were found to be non-inferior with CIC treatment compared with KC treatment in both study populations (ITT population: 37% CIC responders and 34% KC responders; in the PP population: 39 and 36% responders, respectively). The 95% confidence interval limit for differences were –7.99–13.56 in the ITT population, and –8.06–14.5 in the PP population. At the end of the maintenance phase, treatment response to CIC was greater than to KC in both ITT and PP populations (57 and 44% in both populations, respectively, p = 0.03). Local tolerance as well as global acceptability was better with CIC than with KC (p = 0.001, intergroup analysis). Conclusion: CIC 1% administered as a cream demonstrated to be non-inferior to KC 2% foaming gel in mild to moderate facial seborrheic dermatitis.

Topical Retapamulin Ointment, 1%, versus Sodium Fusidate Ointment, 2%, for Impetigo: A Randomized, Observer-Blinded, Noninferiority Study

“…It was decided not to use a double-blind, double-dummy design, partly for reasons discussed by the authors of a similar trial [25]. Such a protocol would have been difficult to implement given the different appearances of the two ointments, thereby compromising the blinding of treatment.…”

Etiology and Management of Seborrheic Dermatitis

“…Ciclopirox shows a good efficacy/tolerance ratio in mild to moderate SD [61]. Ciclopirox inhibits prostaglandin and leukotriene synthesis [62].…”

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“…A randomized, open labeled clinical study was conducted by Chosidow et al [42] to compare ciclopirox olamine 1% cream and ketoconazole 2% foaming gel in patients with mild to moderate facial SD. The authors found that at the end of the maintenance phase, treatment response to ciclopirox olamine was greater than to ketoconazole in both intention-to-treat (ITT) and per protocol (PP) populations.42 However, while the group applying ciclopirox was using it twice daily, the group applying ketoconazole gel was using it only twice a week during the initial phase.…”