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This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.
This Phase IIa pilot multiple-dose study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVXT Solution | Experimental | NVXT Solution once daily for 60 days |
|
| Vehicle of test product | Placebo Comparator | Vehicle of test product, once daily for 60 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVXT Solution | Drug | NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Negative Fungal Culture | To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taro Pharmaceuticals USA | Taro Pharmaceuticals USA Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | NVXT Solution | NVXT Solution once daily for 60 days NVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days. |
| FG001 | Vehicle of Test Product | Vehicle of test product, once daily for 60 days Vehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NVXT Solution | NVXT Solution once daily for 60 days NVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days. |
| BG001 | Vehicle of Test Product |
| 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 | Number of Participants With Negative Fungal Culture | To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days | Subjects with fungal culture collected at the study day 28 visit. The subjects may not complete all study visits. | Posted | Count of Participants | Participants | 28 days |
|
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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 | NVXT Solution | NVXT Solution once daily for 60 days NVXT Solution: NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical | Taro Pharmaceuticals U.S.A. Inc | +1 914-345-900 | Natalie.Yantovskiy@Taro.com |
| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| Vehicle of test product | Drug | Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days. |
|
|
Vehicle of test product, once daily for 60 days
Vehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 0 |
| 35 |
| 7 |
| 35 |
| EG001 | Vehicle of Test Product | Vehicle of test product, once daily for 60 days Vehicle of test product: Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days. | 0 | 12 | 3 | 12 |
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Common Cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pharangitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Muscle Spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Exacerbation of Tinea Pedis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |