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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01358240
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : September 28, 2012
AmDerma Pharmaceuticals, LLC
Information provided by (Responsible Party):

Brief Summary:
This is a study of the safety and efficacy of 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. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 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 of Econazole Nitrate Foam 1% vs Foam Vehicle and an Evaluator-Blinded Comparison of Econazole Nitrate Foam 1% and Econazole Nitrate Cream 1% in Subjects With Interdigital Tinea Pedis
Study Start Date : June 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

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
Drug: Vehicle Foam
Vehicle Foam applied once a day for 4 week

Active Comparator: Econazole Nitrate Cream 1%
Econazole Nitrate Cream 1%
Drug: Econazole Nitrate Cream 1%
Econazole Nitrate Foam 1% applied once a day for 4 weeks

Sham Comparator: Placebo Cream
Placebo Cream
Other: Placebo Cream
Placebo cream applied once a day for 4 weeks

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 system at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only.

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, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only.

  2. Mycological Cure [ Time Frame: Day 43 ]
    Mycological Cure defined as negative KOH and negative culture at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 least 2 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 (Section 10.1) 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 (UPT) 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01358240

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United States, California
Sunil S. Dhawan, MD
Fremont, California, United States, 94538
United States, Delaware
Guy F. Webster, MD, PhD
Hockessin, Delaware, United States, 19707
United States, Florida
Marta I. Rendon, MD
Boca Raton, Florida, United States, 33486
Jonathan Kantor, MD
Jacksonville, Florida, United States, 32204
United States, Minnesota
Steven E. Kempers, MD
Fridley, Minnesota, United States, 55432
United States, Nebraska
Joel Schlessinger, MD
Omaha, Nebraska, United States, 68144
United States, Oregon
Phoebe Rich, MD
Portland, Oregon, United States, 97210
United States, Tennessee
Edward J. Primka III, MD
Knoxville, Tennessee, United States, 37917
United States, Texas
Michael T. Jarratt, MD
Austin, Texas, United States, 78759
William Abramovits, MD
Dallas, Texas, United States, 75230
United States, Virginia
David M. Pariser, MD, FAAD, FACP
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Harry H. Sharata, MD, PhD
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
AmDerma Pharmaceuticals, LLC
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Study Director: Daniel Piacquadio, MD Therapeutics, Inc.
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Responsible Party: AmDerma Identifier: NCT01358240    
Other Study ID Numbers: 079-2951-303
First Posted: May 23, 2011    Key Record Dates
Last Update Posted: September 28, 2012
Last Verified: September 2012
Keywords provided by AmDerma:
Econazole Nitrate
Tinea Pedis
Additional relevant MeSH terms:
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Tinea Pedis
Bacterial Infections and Mycoses
Skin Diseases, Infectious
Skin Diseases
Foot Dermatoses
Foot Diseases
Skin Manifestations
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