NCT02546258

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	A Fungal Nail Treatment	treats the signs of mild fungal nail infections

Timeline

• Start date: 2014-08-25
• Primary completion: 2014-11-21
• Completion: 2014-11-21
• First posted: 2015-09-10
• Last updated: 2017-04-11

Locations

1 site across 1 country: United Kingdom