Evaluation of the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Open Label, Non-comparative Clinical Investigation to Evaluate the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis

Conditions
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Onychomycosis of Toenails

Intervention / Treatment
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* Device: A Fungal Nail Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent has been obtained. Age between 18 years to 65 years inclusive. Gender: male and female subjects. Subjects with visual signs of MILD fungal nail infection present on at least one big toenail or with fungal nail infection on one other toenail on the same foot, in addition to the target big toenail (condition of other foot not relevant) as per podiatrist visual assessment. Subjects with no more than 50% surface area of the target big toenail visually affected, from the leading distal edge, as assessed by the podiatrist. Exclusion Criteria: Subjects with moderate to severe fungal toenail infection, on either big toenail, as determined by podiatrist assessment. Subjects with fungal nail infection on more than two toenails on their target foot. Subjects reporting presence of visual symptoms of fungal toenail infection for more than five years.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A Funagl Nail Treatment<br>Marketed treatment of Fungal Nail Follow instructions on pack | Device: A Fungal Nail Treatment<br>* treats the signs of mild fungal nail infections<br>* Other names: Funagl Nail Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction of the surface area of infection over time using image analysis |  | 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fungal Nail