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

Onychomycosis of Toenails Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546258
• Other study ID #: NPD810
• Status: Completed
• Phase: N/A
• First received: September 8, 2015
• Last updated: April 10, 2017
• Start date: August 25, 2014
• Est. completion date: November 21, 2014

Study information

• Verified date: November 2015
• Source: Reckitt Benckiser Healthcare (UK) Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 21, 2014
• Est. primary completion date: November 21, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Onychomycosis
• Onychomycosis of Toenails

Intervention

Device:
• A Fungal Nail Treatment
treats the signs of mild fungal nail infections

Locations

Country	Name	City	State
United Kingdom	Intertek CRS	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Reckitt Benckiser Healthcare (UK) Limited	Intertek

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage reduction of the surface area of infection over time using image analysis		40 weeks
Secondary	Percentage reduction of the surface area of infection over time from baseline to week 4 using image analysis		4 weeks
Secondary	The proportion of subjects whose fungal nail infection has resolved		40 weeks