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

NCT ID: NCT01353976

Last Updated: 2013-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-08-31

Brief Summary

This is a study of the safety and efficacy of topical 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.

Conditions

Tinea Pedis; Athlete's Foot

Study Design

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

Study Groups

Econazole Nitrate Foam 1%

Study medication

Group Type: EXPERIMENTAL

Econazole Nitrate Foam 1%

Intervention Type: DRUG

Econazole Nitrate Foam 1% applied once a day for 4 weeks

Vehicle Foam

Placebo medication

Group Type: PLACEBO_COMPARATOR

Vehicle Foam

Intervention Type: OTHER

Vehicle foam applied once a day for 4 weeks

Interventions

Econazole Nitrate Foam 1%

Econazole Nitrate Foam 1% applied once a day for 4 weeks

Intervention Type: DRUG

Vehicle Foam

Vehicle foam applied once a day for 4 weeks

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AmDerma Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: collaborator

AmDerma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Piacquadio, MD

Role: STUDY_DIRECTOR

Therapeutics, Inc.

Locations

Francisco Flores, MD

Miramar, Florida, United States

Daniel M. Stewart, DO

Clinton Township, Michigan, United States

Cyaandi Dove, DPM

Las Vegas, Nevada, United States

Robert S. Haber, MD

South Euclid, Ohio, United States

Cynthia Strout, MD

Mt. Pleasant, South Carolina, United States

Michael H. Gold, MD

Nashville, Tennessee, United States

Jeffrey Adelglass, MD

Plano, Texas, United States

Countries

United States

Other Identifiers

079-2951-302

Identifier Type: -

Identifier Source: org_study_id