Titre du document / Document title

Efficacy and tolerability of terbinafine 1% topical solution used for 1 week compared with 4 weeks clotrimazole 1% topical solution in the treatment of interdigital tinea pedis : A randomized, double-blind, multi-centre, 8-week clinical trial

Auteur(s) / Author(s)

SCHOPF R. ⁽¹⁾ ; HETTLER O. ⁽²⁾ ; BRÄUTIGAM M. ⁽³⁾ ; WEIDINGER G. ⁽³⁾ ; KABEN U. ⁽⁴⁾ ; MAYSER P. ⁽⁵⁾ ; RESL V. ⁽⁶⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Department of Dermatology, University of Mainz, ALLEMAGNE
⁽²⁾ Novartis Pharma AG, Basel, SUISSE
⁽³⁾ Novartis Pharma GmbH, Clinical Research Department, Nuremberg, ALLEMAGNE
⁽⁴⁾ Institute of Medical Microbiology and Hygiene, University of Rostock, ALLEMAGNE
⁽⁵⁾ Department of Dermatology, University of Giessen, ALLEMAGNE
⁽⁶⁾ Department of Dermatovenerology, Charles University, Plzen, TCHEQUE, REPUBLIQUE

Résumé / Abstract

In this double-blind clinical trial 429 patients (217 terbinafine and 212 clotrimazole) were randomized to receive twice daily terbinafine 1% topical solution for 1 weck followed by a vehicle application for 3 weeks, or 1% clotrimazole solution for 4 weeks. Patients were evaluated clinically and mycologically at baseline and then at weeks one, two, four (end of treatment), and eight (end of follow-up). To be evaluable the patient needed to have a positive culture for a dermatophyte and positive KOH microscopy and a clinical diagnosis of tinea pedis (interdigital type) at baseline. Effective treatment of tinea pedis was recorded in 181 of 217 (83%) of patients treated for 1 week with terbinafine 1% solution and 174 of 212 (82%) of patients treated for 4 weeks with clotrimazole 1% solution. Mycological cure and disappearance of signs and symptoms were similar at each assessment visit in the two groups. In the subgroup ofpatients without any protocol violation the mycological cure rate was 95% (164 of 173) with terbinafine solution and 91% (159 of 174) with clotrimazole solution (P=0.05). Adverse events believed to be drug-related occurred in 13 patients in the terbinafine group and 11 in the clotrimazole group (4 to 5% in each group). The events were primarily local skin reactions of mild to moderate intensity. It can be concluded that terbinafine 1% solution used for 1 week to treat tinea pedis is well tolerated and at least as effective as clotrimazole 1% solution used for 4 weeks.

Revue / Journal Title

Mycoses   ISSN 0933-7407 

Source / Source

1999, vol. 42, n^o5-6, pp. 415-420 (17 ref.)

Langue / Language

Anglais

Editeur / Publisher

Blackwell, Berlin, ALLEMAGNE  (1988) (Revue)

Mots-clés anglais / English Keywords

Mycosis ; Skin ; Toe ; Chemotherapy ; Treatment ; Antifungal agent ; Terbinafine ; Comparative study ; Clotrimazole ; Local administration ; Percutaneous route ; Human ; Double blind study ; Allylic compound ; Amine ; Imidazole derivatives ; Infection ; Skin disease ;

Mots-clés français / French Keywords

Mycose ; Peau ; Orteil ; Chimiothérapie ; Traitement ; Antifongique ; Terbinafine ; Etude comparative ; Clotrimazole ; Voie locale ; Voie percutanée ; Homme ; Etude double insu ; Composé allylique ; Amine ; Imidazole dérivé ; Infection ; Peau pathologie ;

Mots-clés espagnols / Spanish Keywords

Micosis ; Piel ; Ortejo ; Quimioterapia ; Tratamiento ; Antifúngico ; Terbinafina ; Estudio comparativo ; Clotrimazol ; Vía local ; Vía percutánea ; Hombre ; Estudio doble ciego ; Compuesto alílico ; Amina ; Imidazol derivado ; Infección ; Piel patología ;

Localisation / Location

INIST-CNRS, Cote INIST : 4156 B, 35400008969066.0070