Back to resultsEvaluation of the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis
Primary Purpose
Onychomycosis of Toenails
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
A Fungal Nail Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis of Toenails focused on measuring Fungal Nail
Eligibility Criteria
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.
Sites / Locations
- Intertek CRS
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A Funagl Nail Treatment
Arm Description
Marketed treatment of Fungal Nail Follow instructions on pack
Outcomes
Primary Outcome Measures
Percentage reduction of the surface area of infection over time using image analysis
Secondary Outcome Measures
Percentage reduction of the surface area of infection over time from baseline to week 4 using image analysis
The proportion of subjects whose fungal nail infection has resolved
Full Information
NCT ID
NCT02546258
First Posted
September 8, 2015
Last Updated
April 10, 2017
Sponsor
Reckitt Benckiser Healthcare (UK) Limited
Collaborators
Intertek
1. Study Identification
Unique Protocol Identification Number
NCT02546258
Brief Title
Evaluation of the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis
Official Title
A Prospective, Open Label, Non-comparative Clinical Investigation to Evaluate the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 25, 2014 (Actual)
Primary Completion Date
November 21, 2014 (Actual)
Study Completion Date
November 21, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reckitt Benckiser Healthcare (UK) Limited
Collaborators
Intertek
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis of Toenails
Keywords
Fungal Nail
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A Funagl Nail Treatment
Arm Type
Other
Arm Description
Marketed treatment of Fungal Nail Follow instructions on pack
Intervention Type
Device
Intervention Name(s)
A Fungal Nail Treatment
Other Intervention Name(s)
Funagl Nail Treatment
Intervention Description
treats the signs of mild fungal nail infections
Primary Outcome Measure Information:
Title
Percentage reduction of the surface area of infection over time using image analysis
Time Frame
40 weeks
Secondary Outcome Measure Information:
Title
Percentage reduction of the surface area of infection over time from baseline to week 4 using image analysis
Time Frame
4 weeks
Title
The proportion of subjects whose fungal nail infection has resolved
Time Frame
40 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rashid Haye, MBBS MD
Organizational Affiliation
Intertek CRS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intertek CRS
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Performance of a Fungal Nail Treatment on the Visual Signs of Onychomycosis
We'll reach out to this number within 24 hrs