Econazole nitrate foam 1% for the treatment of tinea pedis: results from two double-blind, vehicle-controlled, phase 3 clinical trials.

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.

• Authors: Boni E Elewski, Tracey C Vlahovic
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 13 Issue 7 Pg. 803-8 (Jul 2014) ISSN: 1545-9616 [Print] United States
• PMID: 25007362 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antifungal Agents
• Econazole

Topics

• Administration, Cutaneous
• Adult
• Antifungal Agents (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Econazole (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Male
• Middle Aged
• Tinea Pedis (drug therapy)
• Treatment Outcome