Athlete's Foot, Tinea Pedis
Conditions
Keywords
Econazole Nitrate, Foam, Quinnova, Tinea Pedis
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.
Interventions
Econazole Nitrate Foam 1% applied once a day for 4 weeks
OTHERVehicle Foam
Vehicle foam applied once a day for 4 weeks
Sponsors
AmDerma Pharmaceuticals, LLC
AmDerma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Cure | Day 43 | Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and symptom at Day 43. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effective Treatment | Day 43 | Effective Treatment defined as negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43. |
| Mycological Cure | Day 43 | Mycological Cure defined as negative KOH and negative culture at Day 43. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Econazole Nitrate Foam 1% Study medication | 130 |
| Vehicle Foam Placebo medication | 134 |
| Total | 264 |
Baseline characteristics
| Characteristic | Econazole Nitrate Foam 1% | Vehicle Foam | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 121 Participants | 125 Participants | 246 Participants |
| Age Continuous | 41.7 years STANDARD_DEVIATION 12.48 | 42.5 years STANDARD_DEVIATION 12.85 | 42.1 years STANDARD_DEVIATION 12.65 |
| Region of Enrollment Dominican Republic | 39 participants | 42 participants | 81 participants |
| Region of Enrollment United States | 91 participants | 92 participants | 183 participants |
| Sex: Female, Male Female | 45 Participants | 56 Participants | 101 Participants |
| Sex: Female, Male Male | 85 Participants | 78 Participants | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 130 | 16 / 134 |
| serious Total, serious adverse events | 0 / 130 | 1 / 134 |
Outcome results
Primary
Complete Cure
Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and symptom at Day 43.
Time frame: Day 43
Population: MITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Econazole Nitrate Foam 1% | Complete Cure | No | 63 Participants |
| Econazole Nitrate Foam 1% | Complete Cure | Yes | 19 Participants |
| Vehicle Foam | Complete Cure | Yes | 2 Participants |
| Vehicle Foam | Complete Cure | No | 81 Participants |
Secondary
Effective Treatment
Effective Treatment defined as negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43.
Time frame: Day 43
Population: MITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Econazole Nitrate Foam 1% | Effective Treatment | No | 42 Participants |
| Econazole Nitrate Foam 1% | Effective Treatment | Yes | 40 Participants |
| Vehicle Foam | Effective Treatment | No | 74 Participants |
| Vehicle Foam | Effective Treatment | Yes | 9 Participants |
Secondary
Mycological Cure
Mycological Cure defined as negative KOH and negative culture at Day 43.
Time frame: Day 43
Population: MITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Econazole Nitrate Foam 1% | Mycological Cure | No | 26 Participants |
| Econazole Nitrate Foam 1% | Mycological Cure | Yes | 56 Participants |
| Vehicle Foam | Mycological Cure | No | 70 Participants |
| Vehicle Foam | Mycological Cure | Yes | 13 Participants |