Clinical trial NCT01358240: Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Pedis
Athlete's Foot
Keywords: Econazole Nitrate
Foam
Quinnova
Tinea Pedis
Lead sponsor: AmDerma
Sponsor class: INDUSTRY
Collaborators: name: AmDerma Pharmaceuticals, LLC
First posted: 2011-05-23
Enrollment: 336
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: Complete Cure
timeFrame: Day 43
Secondary outcomes:
measure: Effective Treatment
timeFrame: Day 43
measure: Mycological Cure
timeFrame: Day 43
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Sunil S. Dhawan, MD
state: California
city: Hockessin
country: United States
facility: Guy F. Webster, MD, PhD
state: Delaware
city: Boca Raton
country: United States
facility: Marta I. Rendon, MD
state: Florida
city: Jacksonville
country: United States
facility: Jonathan Kantor, MD
state: Florida
city: Fridley
country: United States
facility: Steven E. Kempers, MD
state: Minnesota
city: Omaha
country: United States
facility: Joel Schlessinger, MD
state: Nebraska
city: Portland
country: United States
facility: Phoebe Rich, MD
state: Oregon
city: Knoxville
country: United States
facility: Edward J. Primka III, MD
state: Tennessee
city: Austin
country: United States
facility: Michael T. Jarratt, MD
state: Texas
city: Dallas
country: United States
facility: William Abramovits, MD
state: Texas
city: Norfolk
country: United States
facility: David M. Pariser, MD, FAAD, FACP
state: Virginia
city: Madison
country: United States
facility: Harry H. Sharata, MD, PhD
state: Wisconsin
Study officials:
affiliation: Therapeutics, Inc.
name: Daniel Piacquadio, MD
role: STUDY_DIRECTOR
References: