Skip to main content
OpenTrials
Completed

NCT Number: NCT02546258

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Onychomycosis of Toenails

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intertek CRS

Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A Fungal Nail Treatment

Device

treats the signs of mild fungal nail infections

Other names: Funagl Nail Treatment

Primary outcomes

  1. Percentage reduction of the surface area of infection over time using image analysis

    Time frame: 40 weeks

Secondary outcomes

  1. Percentage reduction of the surface area of infection over time from baseline to week 4 using image analysis

    Time frame: 4 weeks

  2. The proportion of subjects whose fungal nail infection has resolved

    Time frame: 40 weeks

Sponsors and collaborators

Lead sponsor

Reckitt Benckiser Healthcare (UK) Limited

Industry

Collaborators

  • Intertek

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2015
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.