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Ciclopirox gel in the treatment of patients with interdigital tinea pedis
Author(s) -
Aly Raza,
Fisher George,
Katz H. Irving,
Levine Norman,
Lookingbill Donald P.,
Lowe Nicholas,
Menter Alan,
Morman Manuel,
Pariser David M.,
Roth Harry L.,
Savin Ronald C.,
Shavin Joel S.,
Stewart Daniel,
Taylor J. Richard,
Tucker Stephen,
Wortzman Mitchell
Publication year - 2003
Publication title -
international journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.677
H-Index - 93
eISSN - 1365-4632
pISSN - 0011-9059
DOI - 10.1046/j.1365-4362.42.s1.6.x
Subject(s) - medicine , dermatology
Background Tinea pedis (athlete’s foot) is the most common fungal infection in the general population. Ciclopirox, a broad‐spectrum hydroxypyridone antifungal, has proven efficacy against the organisms commonly implicated in tinea pedis: Trichophyton rubrum , T. mentagrophytes and Epidermophyton floccosum . Objective Two multicenter, double‐blind, clinical studies compared the efficacy and safety of ciclopirox gel with that of its vehicle base in subjects with moderate interdigital tinea pedis with or without plantar involvement. Methods Three hundred and seventy‐four subjects were enrolled and randomized to one of two treatment groups: ciclopirox gel 0.77%, or ciclopirox gel vehicle, applied twice daily for 28 days, with a final visit up to day 50. The primary efficacy variable was Treatment Success defined as combined mycological cure and clinical improvement 75%. Secondary measures of effectiveness were Global Clinical Response, Sign and Symptom Severity Scores, Mycological Evaluation (KOH examination and final culture result), Mycological Cure (negative KOH and negative final culture results) and Treatment Cure (combined clinical and mycological cure). Results At endpoint (final post‐baseline visit), 60% of the ciclopirox subjects achieved treatment success compared to 6% of the vehicle subjects. At the same time point, 66% of ciclopirox subjects compared with 19% of vehicle subjects were either cleared or had excellent improvement. Pooled data showed that 85% of ciclopirox subjects were mycologically cured, compared to only 16% of vehicle subjects at day 43, 2 weeks post‐treatment. Conclusions Ciclopirox gel 0.77% applied twice daily for 4 weeks is an effective treatment of moderate interdigital tinea pedis due to T. rubrum , T. mentagrophytes and E. floccosum and is associated with a low incidence of minor adverse effects.