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

Condition(s) targeted: Tinea Pedis; Athlete's Foot

Intervention: Econazole Nitrate Foam 1% (Drug); Vehicle Foam (Drug); Econazole Nitrate Cream 1% (Drug); Placebo Cream (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Quinnova Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Daniel Piacquadio, MD, Study Director, Affiliation: Therapeutics, Inc.

Overall contact:
Daniel Piquadio, MD, Phone: 858-571-1800, Email: danp@therapeuticsinc.com

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Complete Cure

Secondary outcome:

Effective Treatment

Mycological Cure

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Daniel Piquadio, MD, Phone: 858-571-1800, Email: danp@therapeuticsinc.com

Sunil S. Dhawan, MD, Fremont, California 94538, United States; Recruiting

Guy F. Webster, MD, PhD, Hockessin, Delaware 19707, United States; Recruiting

Marta I. Rendon, MD, Boca Raton, Florida 33486, United States; Recruiting

Jonathan Kantor, MD, Jacksonville, Florida 32204, United States; Recruiting

Steven E. Kempers, MD, Fridley, Minnesota 55432, United States; Recruiting

Joel Schlessinger, MD, Omaha, Nebraska 68144, United States; Recruiting

Phoebe Rich, MD, Portland, Oregon 97210, United States; Recruiting

Edward J. Primka III, MD, Knoxville, Tennessee 37917, United States; Recruiting

Michael T. Jarratt, MD, Austin, Texas 78759, United States; Recruiting

William Abramovits, MD, Dallas, Texas 75230, United States; Recruiting

David M. Pariser, MD, FAAD, FACP, Norfolk, Virginia 23507, United States; Recruiting

Harry H. Sharata, MD, PhD, Madison, Wisconsin 53719, United States; Recruiting

Starting date: May 2011
Last updated: June 3, 2011