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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Tinea Pedis; Athlete's Foot	Drug: Econazole Nitrate Foam 1%; Other: Vehicle Foam	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	264 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	May 2011
Actual Primary Completion Date :	April 2012
Actual Study Completion Date :	August 2012

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. Complete Cure [ Time Frame: Day 43 ]
   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.

Secondary Outcome Measures :

1. Effective Treatment [ Time Frame: Day 43 ]
   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.
2. Mycological Cure [ Time Frame: Day 43 ]
   Mycological Cure defined as negative KOH and negative culture at Day 43.

Eligibility Criteria

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Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

AmDerma

AmDerma Pharmaceuticals, LLC

Investigators

Study Director:	Daniel Piacquadio, MD	Therapeutics, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	AmDerma
ClinicalTrials.gov Identifier:	NCT01353976 History of Changes
Other Study ID Numbers:	079-2951-302
First Posted:	May 16, 2011
Results First Posted:	January 9, 2013
Last Update Posted:	January 9, 2013
Last Verified:	December 2012

Keywords provided by AmDerma:

Econazole Nitrate; Foam; Quinnova; Tinea Pedis

Additional relevant MeSH terms:

Tinea; Tinea Pedis; Dermatomycoses; Skin Diseases, Infectious; Infection; Mycoses; Skin Diseases; Foot Dermatoses; Foot Diseases; Pruritus; Skin Manifestations; Signs and Symptoms	Econazole; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs