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

NCT ID: NCT00768599

Last Updated: 2013-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-10-31

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.

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).

Conditions

Tinea Pedis; Athlete's Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Econazole Nitrate Cream 1%

Group Type: ACTIVE_COMPARATOR

Econazole Nitrate Cream 1%

Intervention Type: DRUG

Topical cream, applied once daily for 4 weeks.

2

Econazole Nitrate Foam 1%

Group Type: EXPERIMENTAL

Econazole Nitrate Foam 1%

Intervention Type: DRUG

Topical foam, applied once daily for 4 weeks.

3

Vehicle Foam

Group Type: PLACEBO_COMPARATOR

Vehicle Foam

Intervention Type: DRUG

Topical foam, applied once daily for 4 weeks.

Interventions

Econazole Nitrate Cream 1%

Topical cream, applied once daily for 4 weeks.

Intervention Type: DRUG

Econazole Nitrate Foam 1%

Topical foam, applied once daily for 4 weeks.

Intervention Type: DRUG

Vehicle Foam

Topical foam, applied once daily for 4 weeks.

Intervention Type: DRUG

Other Intervention Names

Econazole Nitrate Cream 1%, Fougera - Altana Inc.; Quinnova Econazole Nitrate Foam 1%; Quinnova Foam Vehicle

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AmDerma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stacy Smith, MD

San Diego, California, United States

Daniel Stewart, DO

Clinton Township, Michigan, United States

Steven Kempers, MD

Fridley, Minnesota, United States

Michael Gold, MD

Nashville, Tennessee, United States

Michael Jarratt, MD

Austin, Texas, United States

Leonard Swinyer, MD

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

D79-2902-07

Identifier Type: -

Identifier Source: org_study_id