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

NCT02546258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-04-11

No results posted yet for this study

Summary

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.

Conditions

  • Onychomycosis of Toenails

Interventions

DEVICE

A Fungal Nail Treatment

treats the signs of mild fungal nail infections

Sponsors & Collaborators

  • Intertek

    collaborator INDUSTRY

  • Reckitt Benckiser Healthcare (UK) Limited

    lead INDUSTRY

Principal Investigators

  • Rashid Haye, MBBS MD · Intertek CRS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-25
Primary Completion
2014-11-21
Completion
2014-11-21

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02546258 on ClinicalTrials.gov