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To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Butenafine cream 1% (Taro) | Experimental | Butenafine cream manufactured by Taro applied for 7 days |
|
| Lotrimin Ultra (butenafine) 1% | Active Comparator | Lotrimin Ultra (butenafine) applied for 7 days |
|
| Vehicle | Placebo Comparator | Butenafine vehicle applied for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butenafine cream 1% manufactured by Taro | Drug | Treatment applied to affected area twice daily for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Cure - Superiority Analysis | Therapeutic Cure requires both Clinical Cure and Mycological Cure. Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient was considered a Clinical Cure. Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative. | 42 days |
| Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra | Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure). | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Cure | Subject with clinical and mycological cure at day 7 | 7 days |
| Mycologic Cure | Negative KOH and fungal culture at day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Burbank | California | United States | |||
| Investigator Site |
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Patients 12 years of age and older, who presented with interdigital tinea pedis, with a positive potassium hydroxide test (KOH) and met the inclusion/exclusion criteria were enrolled in the trial. Subsequently samples were sent for culture to confirm that either T. rubrum, T. mentagrophytes, or E. floccosum were the causative organism.
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| ID | Title | Description |
|---|---|---|
| FG000 | Butenafine Cream 1% (Taro) | Butenafine cream manufactured by Taro applied for 7 days |
| FG001 | Lotrimin Ultra (Butenafine) 1% | Lotrimin Ultra (butenafine) applied for 7 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Lotrimin Ultra (butenafine) 1% | Drug | Treatment applied to affected area twice daily for 7 days |
|
| Butenafine Vehicle manufactured by Taro | Drug | Treatment applied to affected area twice daily for 7 days |
|
| 42 days |
| Clinical Cure | The following 8 signs and symptoms are rated at each visit: Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning Each symptom is evaluated using the following scale: 0 = None- Complete absence of any sign or symptom
Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2. | 42 days |
| Safety and Adverse Event Profile | 42 days |
| San Diego |
| California |
| United States |
| Investigator Site | Miami | Florida | United States |
| Investigator Site | Martinez | Georgia | United States |
| Investigator Site | Stockbridge | Georgia | United States |
| Investigator Site | Clinton Township | Michigan | United States |
| Investigator Site | Hickory | North Carolina | United States |
| Investigator Site | Raleigh | North Carolina | United States |
| Investigator Site | Salisbury | North Carolina | United States |
| Investigator Site | Sylvania | Ohio | United States |
| Investigator Site | Simpsonville | South Carolina | United States |
| Investigator Site | Bristol | Tennessee | United States |
| Investigator Site | Nashville | Tennessee | United States |
| Investigator Site | College Station | Texas | United States |
| Investigator Site | Houston | Texas | United States |
| Investigator Site | San Antonio | Texas | United States |
| Investigator Site | Belize City | Belize |
| FG002 | Vehicle | Butenafine vehicle applied for 7 days |
| Positive Fungal Culture |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Butenafine Cream 1% (Taro) | Butenafine cream manufactured by Taro applied for 7 days |
| BG001 | Lotrimin Ultra (Butenafine) 1% | Lotrimin Ultra (butenafine) applied for 7 days |
| BG002 | Vehicle | Butenafine vehicle applied for 7 days |
| BG003 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Therapeutic Cure - Superiority Analysis | Therapeutic Cure requires both Clinical Cure and Mycological Cure. Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient was considered a Clinical Cure. Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative. | Patients with negative cultures at baseline are excluded. Efficacy ITT analysis includes all patients with positive baseline cultures, who received at least one dose of medication, had a follow-up visit and had data for the day 42 visit. | Posted | Number | Participants | 42 days |
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| Secondary | Therapeutic Cure | Subject with clinical and mycological cure at day 7 | ITT Population | Posted | Number | Participants | 7 days |
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| Secondary | Mycologic Cure | Negative KOH and fungal culture at day 42 | ITT population | Posted | Number | Participants | 42 days |
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| Secondary | Clinical Cure | The following 8 signs and symptoms are rated at each visit: Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning Each symptom is evaluated using the following scale: 0 = None- Complete absence of any sign or symptom
Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2. | ITT population | Posted | Number | Participants | 42 days |
|
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| Secondary | Safety and Adverse Event Profile | Not Posted | 42 days | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra | Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure). | Patients with negative cultures excluded. Use per protocol population | Posted | Number | Participants | 42 days |
|
|
Adverse event data was collected over the 42 day duration of the study.
The Safety Population includes all 548 patients who received at least a single dose of medication.
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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 | Butenafine Cream 1% (Taro) | Butenafine cream manufactured by Taro applied for 7 days | 2 | 14 | ||||
| EG001 | Lotrimin Ultra (Butenafine) 1% | Lotrimin Ultra (butenafine) applied for 7 days | 0 | 21 | ||||
| EG002 | Vehicle | Butenafine vehicle applied for 7 days | 1 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Taro Pharmaceuticals | (914) 345-9001 | 6427 | medical.affairs@taro.com |
| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| 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 |
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| ID | Term |
|---|---|
| C067594 | butenafine |
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| Between 18 and 65 years |
|
| >=65 years |
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| Male |
|
| Belize |
|
| <0.0001 |
| 95 |
| No |
| Superiority or Other |
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| Participants |
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