Evaluation of the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis
NCT ID: NCT02546258
Last Updated: 2017-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2014-08-25
2014-11-21
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A Funagl Nail Treatment
Marketed treatment of Fungal Nail Follow instructions on pack
A Fungal Nail Treatment
treats the signs of mild fungal nail infections
Interventions
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A Fungal Nail Treatment
treats the signs of mild fungal nail infections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Intertek
INDUSTRY
Reckitt Benckiser Healthcare (UK) Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Rashid Haye, MBBS MD
Role: PRINCIPAL_INVESTIGATOR
Intertek CRS
Locations
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Intertek CRS
Manchester, , United Kingdom
Countries
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Other Identifiers
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NPD810
Identifier Type: -
Identifier Source: org_study_id
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