A Study to See if Low Level Laser Light Can Help to Treat Toenail Fungus (NCT03066336) | Clinical Trial Compass
WithdrawnNot Applicable
A Study to See if Low Level Laser Light Can Help to Treat Toenail Fungus
Stopped: Difficulty recruiting subjects
United States0Started 2017-04-10
Plain-language summary
The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia LunulaLaser device is effective in clearing toenails with onychomycosis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Visual clinical presentation of onychomycosis in the target great toenail is distal subungual onychomycosis (DSO), visualized as a nail with normal surface texture and thickness but variable "bays" of white nail that extend from the distal nail tip proximally into the area of the nail bed
* Clinical involvement of onychomycosis in the target toenail is up to 60%
* Confirmation of the presence of fungal infection through a positive KOH stain finding and a positive fungal culture finding
* Identification through fungal culture of the growth of Trichophyton rubrum (T. rubrum) or other common dermatophyte or C. albicans or mixed dermatophyte/Candida infection. In the event of the KOH stain and the fungal culture provide conflicting results, i.e., one is positive and the other negative, resolution may be obtained by a second negative fungal culture finding from a nail clipping from the same nail
* Subject is willing and able to refrain from employing other (non-study) treatments (traditional or alternative) for his or her toenail onychomycosis throughout study participation.
* Subject is willing and able to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers throughout study participation
Exclusion Criteria:
* Visual clinical presentations of onychomycosis in the target great toenail that are inconsistent with the clinical presentation of distal subungual onychomycosis (DSO), in whole or in part (i.e. indicative of mixed etiol…
What they're measuring
1
Percent (%) of toenails attaining mycologic cure at study endpoint