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.

1.
Johnson M-LT, Roberts J: Prevalence of dermatological diseases among persons 1–74 years of age. http://www.cdc.gov/nchs/data/nhanes/nhanesi/4151.pdf.
2.
McGrath J, Murphy GM: The control of seborrheic dermatitis and dandruff by antipityrosporal drugs. Drugs 1991;41:178–184.
3.
Green CA, Farr PM, Shuster S: Treatment of seborrheic dermatitis with ketoconazole. II. Response of seborrheic dermatitis of the face, scalp and trunk to topical ketoconazole. Br J Dermatol 1987;116:217–221.
4.
Corte M, Jung K, Linker U, Martini H, Sapp-Boncelet I, Schulz H: Topical application of a 0.1% ciclopiroxolamine solution for the treatment of pityriasis versicolor. Mycoses 1989;32:200–203.
5.
Hanel H, Smith-Kurtz E, Pastowsky S: Treatment of seborrheic eczema using an antimycotic with antiphlogistic properties. Mycoses 1991;34(suppl 1):91–93.
6.
Rosen T, Schell BJ, Orengo I: Anti-inflammatory activity of antifungal preparations. Int J Dermatol 1997;36:788–792.
7.
Dupuy P, Maurette C, Chosidow O: Randomized placebo-controlled, double-blind study on clinical efficacy of ciclopiroxolamine 1% cream in facial seborrheic dermatitis. Br J Dermatol 2001;144:1033–1037.
8.
Ortonne JP, Lacour JP, Vitetta A, Fichoux Y: Comparative study of ketoconazole 2% foaming gel and betamethasone dipropionate 0.05% lotion in the treatment of seborrheic dermatitis in adults. Dermatology 1992;184:275–280.
9.
Peter RU, Richarz-Barthauer U: Successful treatment and prophylaxis of scalp seborrhoeic dermatitis and dandruff with 2% ketoconazole shampoo: Results of a multicentre, double-blind, placebo-controlled trial. Br J Dermatol 1995;132:441–445.
10.
Johnson BA, Nunley JR: Treatment of seborrheic dermatitis. Am Fam Physician 2000;61:2703–2710, 2713–2714.
11.
Jones B, Jarvis P, Lewis JA, Ebbutt AF: Trials to assess equivalence: The importance of vigorous methods. BMJ 1996;313:36–39.
12.
Maietta G, Rongioletti F, Rebora A: Seborrheic dermatitis and daylight. Acta Derm Venereol 1991;71:538–539.
13.
Anonymous: Points to consider on switching between superiority and non-inferiority. Br J Clin Pharmacol 2001;52:223–228.
14.
Schmid MH, Korting HC: Coaltar, pine tar and sulfonated shale oil preparations: Comparative activity, efficacy and safety. Dermatology 1996;193:1–5.
15.
Shemer A, Nathansohn N, Kaplan B, Weiss G, Newman N, Trau H: Treatment of scalp seborrheic dermatitis and psoriasis with an ointment of 40% urea and 1% bifonazole. Int J Dermatol 2000;39:532–534.
16.
Shiri J, Amichai B: Treatment of seborrheic dermatitis of the scalp and dandruff with a shampoo containing 1% bifonazole (Agispor shampoo). J Dermatol Treat 1998;9:95–96.
17.
Skinner RB Jr, Noah PW, Taylor RM, Zanolli MD, West S, Guin JD, Rosenberg EW: Double-blind treatment of seborrheic dermatitis with 2% ketoconazole cream. J Am Acad Dermatol 1985;12:852–856.
18.
Stratigos JD, Antoniou C, Katsambas A, Böhler K, Fritsch P, Schmölz A, Michaelidis D, De Beule K: Ketoconazole 2% cream versus hydrocortisone 1% cream in the treatment of seborrheic dermatitis. J Am Acad Dermatol 1988;19:850–853.
19.
Katsambas A, Antoniou C, Frangouli E, Avgerinou G, Michailidis D, Stratigos J: A double-blind trial of treatment of seborrhoeic dermatitis with 2% ketoconazole cream compared with 1% hydrocortisone cream. Br J Dermatol 1989;121:353–357.
20.
Pari T, Pulimood S, Jacob M, George S, Jeyaseelan L, Thomas K: Randomised double-blind controlled trial of 2% ketoconazole cream versus 0.05% clobetasol 17-butyrate cream in seborrhoeic dermatitis. J Eur Acad Dermatol Venereol 1998;10:89–90.
21.
Korting HC, Grundmann-Kollmann M: The hydroxypyridones: A class of antimycotics of its own. Mycoses 1997;40:243–247.
22.
Vardy DA, Zvulunov A, Tchetov T, Biton A, Rosenman D: A double-blind, placebo-controlled trial of a ciclopiroxolamine 1% shampoo for the treatment of scalp seborrheic dermatitis. J Dermatol Treat 2000;11:73–77.
23.
Schulz H: Ciclopiroxolamin Creme, die therapeutische Alternative beim seborrhoischen Ekzem. Hautnah Dermatol 1988;2:1–5.
24.
Parsad D, Pandhi R, Negi K, Kumar B: Topical metronidazole in seborrheic dermatitis – A double-blind study. Dermatology 2001;202:35–37.
25.
Scaparro E, Quadri G, Virno G, Orifici C, Milanis M: Evaluation of the efficacy and tolerability of oral terbinafine (Daskil®) in patients with seborrhoeic dermatitis. A multicentre, randomized, investigator-blinded, placebo-controlled trial. Br J Dermatol 2001;144:854–857.
26.
Dréno B, Chosidow O, Revuz J, Moyse D, Tachon G et le groupe des dermatologues investigateurs: Gluconate de lithium dans le traitement de la dermatite séborrhéique: Essai randomisé versus gel de kétoconazole. Ann Dermatol Venereol 2001;128:3S47–S48.
27.
Weinstein G, White G: An approach to the treatment of moderate to severe psoriasis with rotational therapy. J Am Acad Dermatol 1993;28:454–459.
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