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Econazole Nitrate Foam 1% for the Treatment of Tinea Pedis: Results From Two Double-Blind, Vehicle-Controlled, Phase 3 Clinical Trials

Econazole Nitrate Foam 1% for the Treatment of Tinea Pedis: Results From Two Double-Blind, Vehicle-Controlled, Phase 3 Clinical Trials

Boni E Elewski, Tracey C Vlahovic

J Drugs Dermatol. 2014 Jul;13(7):803-8.

PMID: 25007362

Abstract:

Background:
Econazole nitrate is a broad-spectrum topical antifungal with activity against a variety of dermatophytes and yeasts. A new topical dosage form, econazole nitrate topical foam 1%, utilizing patented Proderm Technology® has been developed for treatment of interdigital tinea pedis.
Objective:
To evaluate econazole nitrate foam 1% versus foam vehicle for treatment of interdigital tinea pedis.
Methods:
Two randomized, double-blind, parallel-group, vehicle-controlled, multicenter studies enrolled males and females ≥12 years old with a clinical diagnosis of interdigital tinea pedis and baseline fungal culture positive for a dermatophyte. Subjects applied econazole nitrate foam 1% (n=246) or foam vehicle (n=249) once daily for 4 weeks. The primary endpoint was proportion of subjects achieving a complete cure (negative KOH, negative fungal culture, complete resolution of all signs and symptoms) at 2 weeks post-treatment (Day 43). Secondary endpoints included mycologic cure (negative KOH and negative culture) and effective treatment (mycologic cure + no or mild erythema and/or scaling and all other signs and symptoms absent).
Results:
The complete cure rate at Day 43 was 24.3% for econazole nitrate foam 1% vs 3.6% for foam vehicle. In addition, higher rates of mycologic cure (67.6% vs 16.9%) and effective treatment (48.6% vs 10.8%) were observed with econazole nitrate foam 1% versus the foam vehicle. There were few adverse events and only nasopharyngitis and headache were experienced by >1% of subjects. No serious adverse events were reported for econazole nitrate foam 1%.
Conclusions:
Econazole nitrate foam 1% exhibited superiority over foam vehicle for the primary and secondary endpoints with a high mycologic cure rate for all pathogens evaluated. Econazole nitrate foam 1% was safe and well tolerated with a safety profile comparable with the foam vehicle. Econazole nitrate foam 1% presents a novel alternative for the management of tinea pedis.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP68797319	Econazole nitrate		68797-31-9	Price

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