Pharmacology and Treatment

Randomized, Open-Labeled, Non-Inferiority Study between Ciclopiroxolamine 1% Cream and Ketoconazole 2% Foaming Gel in Mild to Moderate Facial Seborrheic Dermatitis
O. Chosidow^a, C. Maurette^b, P. Dupuy^b, for the Study Investigator Group

^aDepartment of Internal Medicine, Hôpital Pitié-Salpétrière, Paris, and
^bPierre-Fabre Research Institute, Vigoulet, France

Address of Corresponding Author

Dermatology 2003;206:233-240 (DOI: 10.1159/000068904)

  Key Words

• Seborrheic dermatitis
• Antifungals
• Ciclopiroxolamine
• Ketoconazole

  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.

Copyright © 2003 S. Karger AG, Basel

  Author Contacts

O. Chosidow, MD, PhD
Department of Internal Medicine
47-83 boulevard de l'Hôpital
F-75013 Paris (France)
Tel. +33 1 4216 1061, Fax +33 1 4216 1058, E-Mail olivier.chosidow@psl.ap-hop-paris.fr

  Article Information

The Study Investigator Group comprised N. Auffret, Paris; D. Penso, B. Berretti, Levallois Perret; C. Aquilina, X. Bouissou, A. Briant, A. Cabarrot, A. Christol, S. Dahan, P. Denis, C. Deriols, V. Gassia, J. Lassere, B. Launais, S. Reberga, Toulouse; J. Chamberlin, A. Hervé-Tranthi, Fontenay aux Roses; P. Alzieu, H. Dutartre, M. Fleischmann, JJ. Renaut, M. Sourisse, Nantes; I. de Capèle, M.T. Dubouix, C. Richard, Muret; M. Payeur, P. van Butsel, Caen; D. Strassman, P. Valensi, Deauville; G. Abirached, C. Pauphilet, Nantèrre; C. Martinage, L. Witt, Porter-sur-Garonne; L. LaVillonière, Le Raincy; Y. Le Corre, Argenteuil; P. Assouly, Malakoff; N. Margeot, Clamart; J.C. Ortoli, Bonneuil-sur-Marne; E. Bourrat, Evry; A. Ostojic, Villeneuve-le-Roy; V. Chazerain, Courbevoie; Y. Drouault, Boulogne Billancourt; P.P. Laget, Bernay; A.M. Heudes, Montreuil; G. Samalens, Coulommiers; A.M. Galissier, Ramonville; France. Presented in part at the Journées Dermatologiques de Paris, 5-8 December 2001, and the 20th World Congress of Dermatology, Paris, 1-5 July 2002.

Received: June 21, 2002
Accepted: September 10, 2002
Number of Print Pages : 8
Number of Figures : 4, Number of Tables : 2, Number of References : 27