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

AmDerma

Status and phase: Completed; Phase 3

Conditions: Athlete's Foot; Tinea Pedis

Treatments: Drug: Econazole Nitrate Cream 1%; Drug: Vehicle Foam; Other: Placebo Cream; Drug: Econazole Nitrate Foam 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358240

079-2951-303

Details and patient eligibility

About

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.

Enrollment: 336 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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336 participants in 4 patient groups, including a placebo group

Econazole Nitrate Foam 1%

Experimental group

Description:

Study medication

Treatment:

Drug: Econazole Nitrate Foam 1%

Vehicle Foam

Placebo Comparator group

Description:

Placebo medication

Treatment:

Drug: Vehicle Foam

Econazole Nitrate Cream 1%

Active Comparator group

Description:

Econazole Nitrate Cream 1%

Treatment:

Drug: Econazole Nitrate Cream 1%

Placebo Cream

Sham Comparator group

Description:

Placebo Cream

Treatment:

Other: Placebo Cream