Treatment of Signs and Symptoms (Pruritus) of Interdigital Tinea Pedis With Econazole Nitrate Foam, 1%

February 2018 | Volume 17 | Issue 2 | Original Article | 229 | Copyright © 2018

Lauren K. Hoffman BS,a Isabelle Raymond PhD,b and Leon Kircik MDa,c

aAlbert Einstein College of Medicine, Bronx, NY bExeltis USA, Florham Park, NJ cIcahn School of Medicine at Mount Sinai Medical Center, New York, NY; Indiana Medical Center, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; DermResearch, PLLC, Louisville, KY

Abstract

BACKGROUND: Tinea pedis is the most common dermatophyte infection. Treatment is critical to alleviate pruritic symptoms, to reduce the risk for secondary bacterial infection, and to limit the spread of infection to other body sites or other individuals. The objective of this study was to compare the abilities of econazole nitrate topical foam, 1% and ketoconazole cream (2%) to reduce pruritus, thus improving quality of life, and to determine patient preference for the foam product versus the cream product in patients with interdigital tinea pedis. STUDY DESIGN: A single-center, investigator-blinded, observational pilot study was conducted to compare econazole nitrate topical foam (1%) to ketoconazole cream (2%). In this split-body study, 20 subjects received both econazole nitrate topical foam and ketoconazole cream and applied the medications daily to either the right or left foot for 14 days. Improvements in patient quality of life (pruritus) and patient preference were measured using the pruritus visual analog scale (VAS), Skindex-16, and patient preference questionnaires. RESULTS: Nineteen subjects completed the study and one subject was lost to follow-up. Reductions in VAS scores of econazole nitrate topical foam were significantly greater than those of ketoconazole cream, indicating the superiority of the econazole nitrate foam in reducing pruritus. Skindex-16 data showed significant reductions in total scores and individual domains, including patient symptom, emotional, and functional domains, by the final visit. Since each subject received both medications the questionnaire was not medication-specific. Responses to patient preference questionnaires showed that econazole nitrate topical foam,1% was rated as “good” or “excellent” in all measures assessed. One adverse event was noted. CONCLUSION: In patients with interdigital tinea pedis, application of econazole nitrate topical foam 1% twice daily for two weeks was clinically effective and significantly superior to ketoconazole cream 2% in reducing pruritus. J Drugs Dermatol. 2018;17(2):229-232.

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INTRODUCTION

Interdigital tinea pedis is the most common fungal infection of the feet. Patients with interdigital tinea pedis present with pruritus, burning, and malodor accompanied by scaling, fissuring, and maceration of the interdigital or subdigital areas, most often the 4th-5th toe web.1-2 Diagnosis is confirmed by microscopic examination of skin scrapings with potassium hydroxide (KOH) to identify fungal hyphae and spores.2 Fungal culture is not necessary because knowledge of the fungal species will not alter treatment decisions.3Management of tinea infection consists of topical antifungals with oral therapy reserved for more extensive disease or when topical therapy has failed.4 Oral drugs, however, are associated with gastrointestinal effects, lack of updated national or international guidelines for treatment, the risk of hepatotoxicity, and possible drug-drug interactions with other systemic treatments.4,5Treatment of interdigital tinea pedis is critical to alleviate pruritic symptoms, reduce the risk for secondary bacterial infection, and limit the spread of infection to other body sites or other individuals.4,6 Topical econazole nitrate 1% foam was shown to be effective against interdigital tinea pedis after 4 weeks of treatment and more recently showed early improvement in quality of life (pruritus) associated with this condition.7,8 The formulation received approval by the US Food and Drug Administration (FDA) in October 2013 for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. The objective of this study was to compare the efficacy and patient preference for econazole nitrate topical foam, 1% versus ketoconazole cream 2% in alleviating pruritus associated with interdigital tinea pedis.

METHODS

A single-center, investigator-blinded, observational, split-body, pilot study was conducted to compare the efficacy and patient preference of econazole nitrate topical foam, 1% (Ecoza™ Foam, Exeltis USA Dermatology, LLC, Florham Park, NJ) versus

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