A Study of Econazole Foam 1% in Athlete's Foot

• ClinicalTrials.gov Identifier: NCT00768599
• Recruitment Status: Completed
• First Posted: October 8, 2008
• Results First Posted: January 9, 2013
• Last Update Posted: January 9, 2013
• Sponsor: AmDerma
• Information provided by (Responsible Party): AmDerma

Study Description

Brief Summary:

This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's foot. This study will help to understand if the foam works the same as the cream to treat athlete's foot.

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

Detailed Description:

Treating athlete's foot with a cream can leave a greasy, wet feeling on the foot that is uncomfortable to the user and messy on clothing and foot wear. A foam formulation that spreads easily and rubs-in easily that is as effective as the (reference) cream formulation in treating athlete's foot would be a benefit to the user. This study is designed to substantiate a clinical bridge between econazole nitrate foam 1% and econazole nitrate cream 1% based on clinical outcome, safety, and pharmacokinetic data. The study is (foam) vehicle-controlled and is randomized 1 to 1 to 1 (foam:cream:vehicle).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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).
2. 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).
3. Mycological Cure: Interdigital Disease [ Time Frame: 43 ]
   Negative KOH and negative fungal culture at Day 43
4. Mycological Cure: Mocassin Disease [ Time Frame: 43 ]
   Negative KOH and negative fungal culture at Day 43

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

AmDerma

More Information

• Responsible Party: AmDerma
• ClinicalTrials.gov Identifier: NCT00768599
• Other Study ID Numbers: D79-2902-07
• First Posted: October 8, 2008
• Results First Posted: January 9, 2013
• Last Update Posted: January 9, 2013
• Last Verified: December 2012

Keywords provided by AmDerma:

Econazole; Foam; Quinnova

Additional relevant MeSH terms:

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