Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis
Condition: Tinea Pedis; Athlete's Foot
MeSH terms: Tinea; Tinea Pedis
Intervention: Econazole Nitrate Foam 1%; Vehicle Foam
Intervention description: Econazole Nitrate Foam 1% applied once a day for 4 weeks; Vehicle foam applied once a day for 4 weeks
Intervention MeSH terms: Econazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 264.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Econazole Nitrate; Foam; Quinnova; Tinea Pedis

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.
    

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.