Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis
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ClinicalTrials.gov Identifier: NCT01353976 |
Recruitment Status :
Completed
First Posted : May 16, 2011
Results First Posted : January 9, 2013
Last Update Posted : January 9, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tinea Pedis Athlete's Foot | Drug: Econazole Nitrate Foam 1% Other: Vehicle Foam | Phase 3 |
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 |

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 |
- 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.
- 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.
- Mycological Cure [ Time Frame: Day 43 ]Mycological Cure defined as negative KOH and negative culture at Day 43.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353976
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 |
Study Director: | Daniel Piacquadio, MD | Therapeutics, Inc. |
Responsible Party: | AmDerma |
ClinicalTrials.gov Identifier: | NCT01353976 |
Other Study ID Numbers: |
079-2951-302 |
First Posted: | May 16, 2011 Key Record Dates |
Results First Posted: | January 9, 2013 |
Last Update Posted: | January 9, 2013 |
Last Verified: | December 2012 |
Econazole Nitrate Foam Quinnova Tinea Pedis |
Tinea Tinea Pedis Dermatomycoses Mycoses Bacterial Infections and Mycoses Infections Skin Diseases, Infectious Skin Diseases Foot Dermatoses Foot Diseases Pruritus Skin Manifestations |
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 |