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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Econazole Nitrate Cream 1% |
|
| 2 | Experimental | Econazole Nitrate Foam 1% |
|
| 3 | Placebo Comparator | Vehicle Foam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Econazole Nitrate Cream 1% | Drug | Topical cream, applied once daily for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 43 |
| 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. | 43 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 43 |
| Effective Treatment: Mocassin Disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stacy Smith, MD | San Diego | California | 92123 | United States | ||
| Daniel Stewart, DO |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reference Drug | Econazole Nitrate Cream 1% |
| FG001 | Test Drug | Econazole Nitrate Foam 1% |
| FG002 | Control | Vehicle Foam |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reference Drug | Econazole Nitrate Cream 1% |
| BG001 | Test Drug | Econazole Nitrate Foam 1% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | MITT | Posted | Number | Participants | Day 43 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reference Drug | Econazole Nitrate Cream 1% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Candis Edwards | AmDerma Pharmaceuticals | 631-974-7949 | cedwards@amderma.com |
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| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| Econazole Nitrate Foam 1% | Drug | Topical foam, applied once daily for 4 weeks. |
|
|
| Vehicle Foam | Drug | Topical foam, applied once daily for 4 weeks. |
|
|
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). |
| 43 |
| Mycological Cure: Interdigital Disease | Negative KOH and negative fungal culture at Day 43 | 43 |
| Mycological Cure: Mocassin Disease | Negative KOH and negative fungal culture at Day 43 | 43 |
| Clinton Township |
| Michigan |
| 48038 |
| United States |
| Steven Kempers, MD | Fridley | Minnesota | 55432 | United States |
| Michael Gold, MD | Nashville | Tennessee | 37215 | United States |
| Michael Jarratt, MD | Austin | Texas | 78759 | United States |
| Leonard Swinyer, MD | Salt Lake City | Utah | 84124 | United States |
| BG002 |
| Control |
Vehicle Foam |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | lbs |
|
|
|
| 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). | MITT | Posted | Number | Participants | 43 |
|
|
|
| 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. | MITT | Posted | Number | Participants | 43 Days |
|
|
|
| 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). | MITT | Posted | Number | Participants | 43 |
|
|
|
| Secondary | Mycological Cure: Interdigital Disease | Negative KOH and negative fungal culture at Day 43 | MITT | Posted | Number | Participants | 43 |
|
|
|
| Secondary | Mycological Cure: Mocassin Disease | Negative KOH and negative fungal culture at Day 43 | MITT | Posted | Number | Participants | 43 |
|
|
|
| 0 |
| 45 |
| 10 |
| 45 |
| EG001 | Test Drug | Econazole Nitrate Foam 1% | 0 | 43 | 10 | 43 |
| EG002 | Control | Vehicle Foam | 0 | 47 | 7 | 47 |
| Dyspepsia | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Tooth Abcess | Gastrointestinal disorders |
|
| Pain | General disorders |
|
| Swelling | General disorders |
|
| Hepatitis C | Hepatobiliary disorders |
|
| Jaundice | Hepatobiliary disorders |
|
| Seasonal Allergy | Immune system disorders |
|
| Sinusitis | Infections and infestations |
|
| Upper Respiratory Tract Infection | Infections and infestations |
|
| Viral Infection | Infections and infestations |
|
| Anthropod Sting | Injury, poisoning and procedural complications |
|
| Thermal Burn | Injury, poisoning and procedural complications |
|
| Blood Bilirubin Increased | Investigations |
|
| Blood Glucose Increased | Investigations |
|
| Blood Lactate Dehydrogenase Increased | Investigations |
|
| Glucose Urine Present | Investigations |
|
| Liver Function Test Abnormal | Investigations |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Paraesthesia | Nervous system disorders |
|
| Haematuria | Renal and urinary disorders |
|
| Nephrolithiasis | Renal and urinary disorders |
|
| Pyuria | Renal and urinary disorders |
|
| Renal Impairment | Renal and urinary disorders |
|
| Pain of Skin | Skin and subcutaneous tissue disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
| Skin Fissures | Skin and subcutaneous tissue disorders |
|
| Stasis Dermatitis | Skin and subcutaneous tissue disorders |
|
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| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |