Light Therapy for Onychomycosis Study

Status Active, not recruiting

Clinical Trial Summary

This is a pilot prospective study designed to capture information about the safety and effectiveness of the ToeFX Therapy Light.

Clinical Trial Description

According to a report published by the NCBI on January 14, 2015, some 3 to 12% of the population is affected by toenfail fungus, with older populations more likely to be affected. Indeed, fungal infection of nails (onychomycosis) is among the most prevalent infectious diseases in humans. According to a communication released by the Ontario College of Physicians and Surgeons in September 2019, the cure rate for topical treatments is only 6-23% after 1 year. Even after 1 year of treatment, topical treatments have limited efficacy. Moreover, onychomycosis is cosmetically distressing. This study will be an open-label, prospective pilot study. The subjects will be 100 patients who suffer from distal subungual onychomycosis. The purpose of the study is to establish the efficacy of the ToeFX Therapy Light, which has shown compelling results in in vitro and ex vivo (cadaver) studies but has not been tested in patients. Specifically, the investigators wish to: 1. Determine the safety and efficacy of this therapy in the treatment of distal subungual onychomycosis of the toenail. 2. Determine the number of treatments required to clear the nail and to cure the fungus. 3. Finalize the treatment protocol, device design and user interface. 4. Test re-infection or recurrence of fungus post-treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05139888
Study type	Interventional
Source	ToeFX Inc.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	February 19, 2020
Completion date	December 19, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03110029` - Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish	Phase 4
Active, not recruiting	`NCT05110638` - Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual Onychomycosis	Phase 1
Completed	`NCT05260450` - Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser	N/A
Completed	`NCT03382717` - Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis	N/A
Not yet recruiting	`NCT06417983` - Topical Application of Essential Oils to Treat Onchomycosis
Withdrawn	`NCT03094468` - Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis	Phase 3
Recruiting	`NCT05674747` - Pilot Study of Swift Microwave Device for Onychomycosis	Phase 1/Phase 2
Recruiting	`NCT06006455` - Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis	N/A
Not yet recruiting	`NCT03098342` - Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment	N/A
Completed	`NCT03216200` - Early Feasibility Study to Evaluate the Efficacy of the RenewalNail™ Plasma Treatment System in Patients With Onychomycosis (Fungal Nail)	N/A
Recruiting	`NCT04042857` - Safety and Efficacy of Next Science Gel on Toenail Fungus	N/A
Active, not recruiting	`NCT05135910` - To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis	Phase 2
Completed	`NCT04961684` - Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis	N/A
Completed	`NCT03141840` - Clinical Trial of Topical ABL01 Treatment of Onychomycosis	N/A
Recruiting	`NCT04084782` - An Internet Mediated Research Study to Assess the Quality of Life of Consumers With Self-reported Fungal Nail Infection (Onychomycosis) During Treatment With Scholl Fungal Nail.
Withdrawn	`NCT03066336` - A Study to See if Low Level Laser Light Can Help to Treat Toenail Fungus	N/A