A randomised pilot clinical investigation of a novel plasma device (PF4) with concurrent controls in toenail onychomycosis

Solent NHS Trust (UK)0 sites80 target enrollmentFebruary 8, 2017

Overview

No summary available.

Registry

who.int

Start Date

February 8, 2017

End Date

December 31, 2018

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Solent NHS Trust (UK)

•1\. Participants who can provide informed consent
•2\. Male or female participants
•3\. Aged 18\-80
•4\. Mycologically confirmed distal subungual onychomycosis in both hallux toenails with 25 – 75% involvement of the nail area

•1\. Participants \< 18 years old
•2\. Participants \> 80 years old
•3\. Participants currently being treated for onychomycosis or who have been treated within the past four months using topical drug therapies
•4\. Participants who have taken oral antifungal agents or had laser treatments in the last 12 months
•5\. Participants who have been involved in other drug or medical device clinical trials in the past 3 months which may affect the safety or efficacy of this study
•6\. Participants with ulcerations around the toe nails
•7\. Participants with total dystrophic onychomycosis involving the lunula/nail matrix
•8\. Participants with peripheral vascular disease, immune\-suppression, loss of sensation in either foot, or with any other medical state which warrants definitive antifungal therapy
•9\. Participants with \<25% or \>75% onychomycosis involvement of the nail area
•10\. No use of nail varnish on the toe nails for at least four weeks before the first treatment and for at least four months after the last treatment