Double‐blind Comparison of Miconazole/Corticosteroid Combination Versus Miconazole in Inflammatory Dermatomycoses

Abstract

Two hundred and fourteen outpatients men and women, aged between 12 and 95 years (mean age: 41 years) and attending dermatology clinics and dermatologists for treatment of inflammatory mycosis and/or dermatitis of various origins, with additional superinfection, were recruited. Informed written consent was obtained from all patients before the study in accordance with the Declaration of Helsinki. The subjects were informed that they may withdraw from the study at any time at their own discretion. Women were excluded if they were pregnant or not using adequate contraception. Further exclusion criteria were: dermatitis of viral or specific origin, systemic treatment with corticosteroids or simultaneous treatment with other topical agents, sensitivity to any component of the test drugs, severe liver disease, or systemic diseases with abnormal skin reactions. Study Medication:Patients were assigned to receive either a cream, containing 0.1 % fluprednidene acetate and 2% miconazoie, or a cream, containing 2 % miconazole. The medication was supplied in identical application tubes and the subjects were instructed to apply the substances twice daily. The oil-in-water cream base was identical in both treatment groups. Study Design:The trial was designed as a prospective, randomized, double-blind parallel-group comparison of two treatments and was performed in Germany in 7 centers. At the start of the treatment, baseline case histories and demographic data were recorded. At baseline, within the first week (after 2-4 days), after 1 and 2 weeks, and at the end of treatment, the following efflorescences and symptoms creating a severity index were assessed: rubor, maceration, vesicles, papules, pustules, desquamation, pruritus, and exudation. A four-stage scale, ranging from "not present (0)" to "severe (3)," was used. As a main target criterion, the subjective onset of efficacy was to be recorded.Pathogen detection was carried out at baseline, after 2-4 days, and at the end of treatment to document the relevant fungi and/or bacteria, either in the native or cultured state. The inclusion criterion defined was that at least one posi-

The association topical antifungals/topical corticosteroids in superficial mycoses of the skin: A critical review of the literature and personal experience

“…These results were substantially confirmed in other studies 2–4 . Miconazole was also associated with 0.1% fluprednidene 5 . Another fixed combination (1% isoconazole/0.1% diflucortolone) was studied in patients with inflammatory superficial mycoses 6–9 .…”

“…[2][3][4] Miconazole was also associated with 0.1% fluprednidene. 5 Another fixed combination (1% isoconazole/0.1% diflucortolone) was studied in patients with inflammatory superficial mycoses. [6][7][8][9] The results of these studies may be summarized as follows: (a) in 284 patients, isoconazole/diflucortolone was superior to isoconazole; tolerability was very good 6 ; (b) in 30 patients, this combination induced a reduction of erythema, scaling and itching 7 ; (c) in a randomized, double-blind trial on 100 patients, this combination was successfully used as initial treatment for 2 weeks.…”

Ausgeprägtes dyshidrosiformes Mykid als Komplikation einer Tinea pedis

“…Durch die Kombination des Antimykotikums mit dem Glukokortikoid kann neben den Entzündungssymptomen wie Rötung und Nässen insbesondere der quälende Juckreiz schnell gelindert werden. In einer randomisierten Doppelblindstudie an 214 Patienten mit entzündlichen Mykosen und superinfizierten Ekzemen ließ sich nachweisen, dass die Anwendung der Kombination Miconazol plus Flupredniden-21-acetat zu einem signifikant schnelleren subjektiven Wirkungseintritt führte als die Verwendung des Miconazol-Monopräparats [15]. Miconazol ist ein Breitspektrum-Antimykotikum mit Wirksamkeit gegen Hefen, Dermatophyten und Schimmelpilze.…”

“…Miconazol ist ein Breitspektrum-Antimykotikum mit Wirksamkeit gegen Hefen, Dermatophyten und Schimmelpilze. Darüber hinaus wirkt es auch gegen einige grampositive Bakterien, die bei Hauterkrankungen eine Rolle spielen, wie zum Beispiel Staphylokokken und Streptokokken [15]. Flupredniden-21-acetat ist ein mittelstark wirksames Kortikoid der Klasse II.…”