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

April 10, 2017 updated by: Reckitt Benckiser Healthcare (UK) Limited

A Prospective, Open Label, Non-comparative Clinical Investigation to Evaluate 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A Funagl Nail Treatment
Marketed treatment of Fungal Nail Follow instructions on pack
Device: A Fungal Nail Treatment
treats the signs of mild fungal nail infections
Other Names:
  • Funagl Nail Treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage reduction of the surface area of infection over time from baseline to week 4 using image analysis
Time Frame: 4 weeks
4 weeks
The proportion of subjects whose fungal nail infection has resolved
Time Frame: 40 weeks
40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reckitt Benckiser Healthcare (UK) Limited

Collaborators

Intertek

Investigators

  • Principal Investigator: Rashid Haye, MBBS MD, Intertek CRS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2014

Primary Completion (Actual)

November 21, 2014

Study Completion (Actual)

November 21, 2014

Study Registration Dates

First Submitted

September 8, 2015

First Submitted That Met QC Criteria

September 8, 2015

First Posted (Estimate)

September 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPD810

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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