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| Name | Class |
|---|---|
| AmDerma Pharmaceuticals, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Econazole Nitrate Foam 1% | Experimental | Study medication |
|
| Vehicle Foam | Placebo Comparator | Placebo medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Econazole Nitrate Foam 1% | Drug | Econazole Nitrate Foam 1% applied once a day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 43 |
| Mycological Cure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Piacquadio, MD | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Francisco Flores, MD | Miramar | Florida | 33027 | United States | ||
| Daniel M. Stewart, DO |
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| ID | Title | Description |
|---|---|---|
| FG000 | Econazole Nitrate Foam 1% | Study medication |
| FG001 | Vehicle Foam | Placebo medication |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Econazole Nitrate Foam 1% | Study medication |
| BG001 | Vehicle Foam | Placebo medication |
| 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 | 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. | 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 | Econazole Nitrate Foam 1% | Study medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral Pain | Gastrointestinal 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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| Vehicle Foam | Other | Vehicle foam applied once a day for 4 weeks |
|
Mycological Cure defined as negative KOH and negative culture at Day 43.
| Day 43 |
| Clinton Township |
| Michigan |
| 48038 |
| United States |
| Cyaandi Dove, DPM | Las Vegas | Nevada | 89119 | United States |
| Robert S. Haber, MD | South Euclid | Ohio | 44118 | United States |
| Cynthia Strout, MD | Mt. Pleasant | South Carolina | 29464 | United States |
| Michael H. Gold, MD | Nashville | Tennessee | 37215 | United States |
| Jeffrey Adelglass, MD | Plano | Texas | 75234 | United States |
| BG002 |
| 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 |
|
| 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. | MITT | Posted | Number | Participants | Day 43 |
|
|
|
| Secondary | Mycological Cure | Mycological Cure defined as negative KOH and negative culture at Day 43. | MITT | Posted | Number | Participants | Day 43 |
|
|
|
| 0 |
| 130 |
| 17 |
| 130 |
| EG001 | Vehicle Foam | Placebo medication | 1 | 134 | 16 | 134 |
| Application Site Dermatitis | General disorders |
|
| Cystitis | Infections and infestations |
|
| Helicobacter gastritis | Infections and infestations |
|
| Influenza | Infections and infestations |
|
| Nasopharyngitis | Infections and infestations |
|
| Sinusitis Bacterial | Infections and infestations |
|
| Upper Respiratory Tract Infection | Infections and infestations |
|
| Ligament Injury | Injury, poisoning and procedural complications |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Headache | Nervous system disorders |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Nasal Dryness | Respiratory, thoracic and mediastinal disorders |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
| Pulmonary Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders |
|
| Hypertension | Vascular 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 |