Athlete's Foot, Tinea Pedis
Conditions
Keywords
Econazole, Foam, Quinnova
Brief summary
This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's foot. This study will help to understand if the foam works the same as the cream to treat athlete's foot.
Detailed description
Treating athlete's foot with a cream can leave a greasy, wet feeling on the foot that is uncomfortable to the user and messy on clothing and foot wear. A foam formulation that spreads easily and rubs-in easily that is as effective as the (reference) cream formulation in treating athlete's foot would be a benefit to the user. This study is designed to substantiate a clinical bridge between econazole nitrate foam 1% and econazole nitrate cream 1% based on clinical outcome, safety, and pharmacokinetic data. The study is (foam) vehicle-controlled and is randomized 1 to 1 to 1 (foam:cream:vehicle).
Interventions
Topical cream, applied once daily for 4 weeks.
Topical foam, applied once daily for 4 weeks.
DRUGVehicle Foam
Topical foam, applied once daily for 4 weeks.
Sponsors
AmDerma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years or age and of either sex. * Has a clinical diagnosis of tinea pedis with at least i) moderate scaling(interdigital and/or moccasin) and ii) mild erythema (interdigital only). * Be willing to give informed consent. * Be willing and able to give informed consent. * Has microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte at Baseline. 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. * Women of childbearing potential must have a negative urine pregnancy test and agree to use an effective, non-prohibited form of birth control for the duration of the study (abstinence, stabilized on oral contraceptives for at least two months, implant, injection, IUD, patch, NuvaRing, condom and spermicidal or diaphragm and spermicidal).
Exclusion criteria
* Is nursing or planning a pregnancy during the study. * Has used topical antifungal or corticosteroid therapy or systemic antibacterial therapy 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 a history of diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications). * Has concurrent tinea infection (in the opinion of the investigator). However, concurrent onychomycosis is allowed. * 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 Rate: Interdigital Disease | Day 43 | A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43. |
| Complete Cure Rate: Moccasin Disease | 43 Days | A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effective Treatment: Interdigital Disease | 43 | 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 (Week6). |
| Effective Treatment: Mocassin Disease | 43 | 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 (Week6). |
| Mycological Cure: Interdigital Disease | 43 | Negative KOH and negative fungal culture at Day 43 |
| Mycological Cure: Mocassin Disease | 43 | Negative KOH and negative fungal culture at Day 43 |
Countries
United States
Participant flow
Recruitment details
One-hundred and ninety-eight (198) subjects were screened and 135 were enrolled/randomized in the study. Subjects with negative KOH evaluations in both regions (all scrapings negative) were considered Screen Failures and were not enrolled into the study. Subject enrollment and completion dates are March 27, 2008 - September 25, 2008.
Pre-assignment details
Subjects who met the inclusion/exclusion criteria were randomized to receive Econazole Nitrate Foam 1%, Econazole Nitrate Cream 1%, or Foam vehicle in a 1:1:1 ratio.
Participants by arm
| Arm | Count |
|---|---|
| Reference Drug Econazole Nitrate Cream 1% | 45 |
| Test Drug Econazole Nitrate Foam 1% | 43 |
| Control Vehicle Foam | 47 |
| Total | 135 |
Baseline characteristics
| Characteristic | Reference Drug | Total | Control | Test Drug |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 9 Participants | 0 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 126 Participants | 47 Participants | 39 Participants |
| Age Continuous | 45.4 years STANDARD_DEVIATION 15.9 | 44.2 years STANDARD_DEVIATION 13.8 | 43.1 years STANDARD_DEVIATION 10.8 | 44.2 years STANDARD_DEVIATION 14.5 |
| Region of Enrollment United States | 45 participants | 135 participants | 47 participants | 43 participants |
| Sex: Female, Male Female | 10 Participants | 31 Participants | 12 Participants | 9 Participants |
| Sex: Female, Male Male | 35 Participants | 104 Participants | 35 Participants | 34 Participants |
| Weight | 194.4 lbs STANDARD_DEVIATION 45.49 | 200.4 lbs STANDARD_DEVIATION 50.42 | 207.0 lbs STANDARD_DEVIATION 49.75 | 199.5 lbs STANDARD_DEVIATION 56.06 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 45 | 10 / 43 | 7 / 47 |
| serious Total, serious adverse events | 0 / 45 | 0 / 43 | 0 / 47 |
Outcome results
Primary
Complete Cure Rate: Interdigital Disease
A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
Time frame: Day 43
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reference Drug | Complete Cure Rate: Interdigital Disease | 9 Participants |
| Test Drug | Complete Cure Rate: Interdigital Disease | 9 Participants |
| Control | Complete Cure Rate: Interdigital Disease | 1 Participants |
Primary
Complete Cure Rate: Moccasin Disease
A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
Time frame: 43 Days
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reference Drug | Complete Cure Rate: Moccasin Disease | 2 Participants |
| Test Drug | Complete Cure Rate: Moccasin Disease | 0 Participants |
| Control | Complete Cure Rate: Moccasin Disease | 0 Participants |
Secondary
Effective Treatment: Interdigital Disease
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 (Week6).
Time frame: 43
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reference Drug | Effective Treatment: Interdigital Disease | 21 Participants |
| Test Drug | Effective Treatment: Interdigital Disease | 16 Participants |
| Control | Effective Treatment: Interdigital Disease | 1 Participants |
Secondary
Effective Treatment: Mocassin Disease
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 (Week6).
Time frame: 43
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reference Drug | Effective Treatment: Mocassin Disease | 3 Participants |
| Test Drug | Effective Treatment: Mocassin Disease | 4 Participants |
| Control | Effective Treatment: Mocassin Disease | 0 Participants |
Secondary
Mycological Cure: Interdigital Disease
Negative KOH and negative fungal culture at Day 43
Time frame: 43
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reference Drug | Mycological Cure: Interdigital Disease | 27 Participants |
| Test Drug | Mycological Cure: Interdigital Disease | 20 Participants |
| Control | Mycological Cure: Interdigital Disease | 4 Participants |
Secondary
Mycological Cure: Mocassin Disease
Negative KOH and negative fungal culture at Day 43
Time frame: 43
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reference Drug | Mycological Cure: Mocassin Disease | 5 Participants |
| Test Drug | Mycological Cure: Mocassin Disease | 5 Participants |
| Control | Mycological Cure: Mocassin Disease | 1 Participants |