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| Name | Class |
|---|---|
| Intertek | INDUSTRY |
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This is a prospective, open label, non-comparative clinical investigation to evaluate the performance of a Fungal Nail Treatment on the visual signs of onychomycosis.
The Fungal Nail Treatment is a CE Marked Class I Medical Device and is commercially available as an over-the-counter product.
The ability of the Fungal Nail Treatment to treat the visual signs of mild fungal toenail infections will be determined by a reduction in the surface area of the infection over time. This will be assessed through visual quantification of the infected area from baseline, as measured by image analysis, throughout the treatment period, where subjects will follow instructions for use on the product pack and self-treat for the duration of the investigation or until their condition has resolved. Both subject and podiatrist will assess the improvement of signs and symptoms of the target nail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Funagl Nail Treatment | Other | Marketed treatment of Fungal Nail Follow instructions on pack |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A Fungal Nail Treatment | Device | treats the signs of mild fungal nail infections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage reduction of the surface area of infection over time using image analysis | 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage reduction of the surface area of infection over time from baseline to week 4 using image analysis | 4 weeks | |
| The proportion of subjects whose fungal nail infection has resolved | 40 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rashid Haye, MBBS MD | Intertek CRS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intertek CRS | Manchester | United Kingdom |
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