Premium
Efficacy and safety of a new single‐dose terbinafine 1% formulation in patients with tinea pedis (athlete's foot): a randomized, double‐blind, placebo‐controlled study
Author(s) -
Ortonne JP,
Korting HC,
ViguiéVallanet C,
Larnier C,
Savaluny E
Publication year - 2006
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/j.1468-3083.2006.01807.x
Subject(s) - medicine , terbinafine , placebo , dermatophyte , itching , randomization , dermatology , randomized controlled trial , clinical trial , surgery , adverse effect , itraconazole , antifungal , alternative medicine , pathology
Background Tinea pedis is a common dermatophyte infection with frequent recurrences. Terbinafine (presently used as a 1‐week topical treatment of tinea pedis) is now available in a novel topical solution (film‐forming solution – FFS), developed to allow single application. Objectives To demonstrate the efficacy and safety of terbinafine 1% FFS in a randomized, double‐blind, placebo‐controlled, phase III trial, and to determine relapse or re‐infection rate of tinea pedis at 12 weeks. Patients/methods Fifty‐four centres (27 in France; 27 in Germany) enrolled 273 evaluable patients (2 : 1 randomization). Patients applied terbinafine 1% FFS or placebo only once between, under and over the toes, soles and sides of both feet. Efficacy assessments included direct microscopy, mycological culture, and clinical signs and symptoms at baseline, and at weeks 1, 6 and 12 after the single drug application. Results Effective treatment (negative mycology plus absent/minimal symptoms) at week 6 in the terbinafine 1% FFS group was 63%; vehicle was 17% ( P 0.0001). Mycological cure was 72% in the terbinafine group and 21% in the placebo ( P 0.0001) at week 6. Clinical signs/symptoms decreased significantly in the active group compared to the placebo. The self‐assessment of itching and burning sensation by the patient showed a clear reduction in symptoms starting 15 min after treatment application (this could be attributed to the cooling effect of the FFS). Recurrence (positive culture at 3 months) occurred in 12.5% of the effectively treated patients at week 6 in the terbinafine group. FFS was well tolerated. Conclusion Terbinafine 1% FFS, single dose application is an effective, safe and convenient treatment for tinea pedis. The relapse/re‐infection rate 3 months after the end of single‐dose therapy is similar to that previously demonstrated in a study using terbinafine 1% cream for 7 days.