Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis

A Multi-Center, Randomized, Double-Blind, Vehicle Controlled, Parallel Group Comparison Study of the Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Interdigital Tinea Pedis

This is a study of the safety and efficacy of topical Econazole Nitrate Foam 1% and the foam vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation.

Study Overview

• Status: Completed
• Conditions: Tinea Pedis; Athlete's Foot
• Intervention / Treatment: Drug: Econazole Nitrate Foam 1%; Other: Vehicle Foam

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miramar, Florida, United States, 33027
      • Francisco Flores, MD
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Daniel M. Stewart, DO
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Cyaandi Dove, DPM
  • Ohio
    • South Euclid, Ohio, United States, 44118
      • Robert S. Haber, MD
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
      • Cynthia Strout, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Michael H. Gold, MD
  • Texas
    • Plano, Texas, United States, 75234
      • Jeffrey Adelglass, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be at least 12 years of age and of either sex.
• Have a clinical diagnosis of interdigital tinea pedis involving at least2 web spaces in total which extends no more than approximately 1 inch proximal to the web spaces or metatarsophalangeal joints with at least i) moderate scaling and ii) mild erythema defined as a Grade 2 and Grade 1, respectively on the Grading of Signs and Symptoms at baseline.
• Be willing and able to give informed consent/assent or have their parent/guardian do so, if applicable.
• Be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study.
• Have microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte in the skin scrapings taken at the Baseline Visit. Subjects with a positive KOH may be entered into the study pending the results of the fungal culture.
• Be in good health and free of any disease or physical condition which might, in the Investigator's opinion, expose the subject to an unacceptable risk by study participation.
• Females must be non-pregnant (confirmed by a negative urine pregnancy test at baseline), non-lactating and not intending to become pregnant during the course of the study.

Exclusion Criteria:

• Is pregnant, nursing or planning a pregnancy during the study.
• Has used topical antifungals or topical corticosteroids on the feet within 30 days prior to the start of the study.
• Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
• Has used systemic antibacterials or systemic corticosteroids within 30 days prior to the start of the study. Systemic corticosteroids do not include intranasal, inhaled, and ophthalmic corticosteroids used for the management of allergies, pulmonary disorders or other conditions.
• Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
• Has concurrent tinea infection e.g. tinea versicolor, tinea cruris, moccasin-type tinea pedis, etc. (in the opinion of the Investigator).
• Onychomycosis, involving ≥ 20% of the area of either great toenail or involvement of more than five toenails in total.
• Has any other skin disease which might interfere with the evaluation of tinea pedis.
• Is currently enrolled in an investigational drug or device study.
• Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study.
• Is unreliable, including subjects with a history of drug or alcohol abuse.
• Has known hypersensitivity to any of the components of the study medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Econazole Nitrate Foam 1%; Study medication	Drug: Econazole Nitrate Foam 1%; Econazole Nitrate Foam 1% applied once a day for 4 weeks
Placebo Comparator: Vehicle Foam; Placebo medication	Other: Vehicle Foam; Vehicle foam applied once a day for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Cure	Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and symptom at Day 43.	Day 43

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective Treatment	Effective Treatment defined as negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43.	Day 43
Mycological Cure	Mycological Cure defined as negative KOH and negative culture at Day 43.	Day 43

Collaborators and Investigators

• Sponsor: AmDerma
• Collaborators: AmDerma Pharmaceuticals, LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: May 12, 2011
• First Submitted That Met QC Criteria: May 12, 2011
• First Posted (Estimate): May 16, 2011

Study Record Updates

• Last Update Posted (Estimate): January 9, 2013
• Last Update Submitted That Met QC Criteria: December 5, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Tinea Pedis; Foam; Quinnova; Econazole Nitrate
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Econazole
• Other Study ID Numbers: 079-2951-302