Light Therapy for Onychomycosis Study (NCT05139888) | Clinical Trial Compass
CompletedNot Applicable
Light Therapy for Onychomycosis Study
Canada126 participantsStarted 2020-02-19
Plain-language summary
This is a pilot prospective study designed to capture information about the safety and effectiveness of the ToeFX Therapy Light.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, with 20% to 50% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement, without lunular or proximal involvement.
* exhibit positive mycology results (i.e., KOH test and culture of a dermatophyte) from the target great toenail, confirming common dermatophytes such as T. rubrum.
* are willing to refrain from using polish or other medication on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator.
* are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails or systemic antifungals for the duration of the study.
* are willing to provide signed and dated written voluntary informed consent in English before any protocol-specific procedures are performed.
* are able to complete the study and comply with study instructions.
Exclusion Criteria:
* females who are pregnant, plan to become pregnant during the study, or are nursing a child.
* persons who are hypersensitive to topical creams, ointments, medications, or surfactants.
* persons who have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study.
* persons who have…
What they're measuring
1
An Increase in Healthy New Nail Growth Free of Fungal Infection ("Clear Nail") at 12 Months Post-treatment