A Study of Econazole Foam 1% in Athlete's Foot
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ClinicalTrials.gov Identifier: NCT00768599 |
Recruitment Status :
Completed
First Posted : October 8, 2008
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 Cream 1% Drug: Econazole Nitrate Foam 1% Drug: Vehicle Foam | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 135 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center Randomized, Evaluator-Blinded, Vehicle Controlled, Parallel Group Comparison Study of the Safety and Efficacy of Econazole Nitrate Foam 1%, Econazole Nitrate 1% Cream, and Foam Vehicle in Subjects With Tinea Pedis |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Econazole Nitrate Cream 1%
|
Drug: Econazole Nitrate Cream 1%
Topical cream, applied once daily for 4 weeks.
Other Name: Econazole Nitrate Cream 1%, Fougera - Altana Inc. |
Experimental: 2
Econazole Nitrate Foam 1%
|
Drug: Econazole Nitrate Foam 1%
Topical foam, applied once daily for 4 weeks.
Other Name: Quinnova Econazole Nitrate Foam 1% |
Placebo Comparator: 3
Vehicle Foam
|
Drug: Vehicle Foam
Topical foam, applied once daily for 4 weeks.
Other Name: Quinnova Foam Vehicle |
- Complete Cure Rate: Interdigital Disease [ Time Frame: Day 43 ]A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
- Complete Cure Rate: Moccasin Disease [ Time Frame: 43 Days ]A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
- Effective Treatment: Interdigital Disease [ Time Frame: 43 ]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 (Week6).
- Effective Treatment: Mocassin Disease [ Time Frame: 43 ]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 (Week6).
- Mycological Cure: Interdigital Disease [ Time Frame: 43 ]Negative KOH and negative fungal culture at Day 43
- Mycological Cure: Mocassin Disease [ Time Frame: 43 ]Negative KOH and negative fungal culture at Day 43

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be at least 18 years or age and of either sex.
- Has a clinical diagnosis of tinea pedis with at least i) moderate scaling(interdigital and/or moccasin) and ii) mild erythema (interdigital only).
- Be willing to give informed consent.
- Be willing and able to give informed consent.
- Has microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte at Baseline. 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.
- Women of childbearing potential must have a negative urine pregnancy test and agree to use an effective, non-prohibited form of birth control for the duration of the study (abstinence, stabilized on oral contraceptives for at least two months, implant, injection, IUD, patch, NuvaRing, condom and spermicidal or diaphragm and spermicidal).
Exclusion Criteria:
- Is nursing or planning a pregnancy during the study.
- Has used topical antifungal or corticosteroid therapy or systemic antibacterial therapy 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 a history of diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
- Has concurrent tinea infection (in the opinion of the investigator). However, concurrent onychomycosis is allowed.
- 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): NCT00768599
United States, California | |
Stacy Smith, MD | |
San Diego, California, United States, 92123 | |
United States, Michigan | |
Daniel Stewart, DO | |
Clinton Township, Michigan, United States, 48038 | |
United States, Minnesota | |
Steven Kempers, MD | |
Fridley, Minnesota, United States, 55432 | |
United States, Tennessee | |
Michael Gold, MD | |
Nashville, Tennessee, United States, 37215 | |
United States, Texas | |
Michael Jarratt, MD | |
Austin, Texas, United States, 78759 | |
United States, Utah | |
Leonard Swinyer, MD | |
Salt Lake City, Utah, United States, 84124 |
Responsible Party: | AmDerma |
ClinicalTrials.gov Identifier: | NCT00768599 |
Other Study ID Numbers: |
D79-2902-07 |
First Posted: | October 8, 2008 Key Record Dates |
Results First Posted: | January 9, 2013 |
Last Update Posted: | January 9, 2013 |
Last Verified: | December 2012 |
Econazole Foam Quinnova |
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 |