Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis (NCT06006455) | Clinical Trial Compass
TerminatedNot Applicable
Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis
Stopped: The study was terminated early by the sponsor for business reasons unrelated to safety. No data analysis was performed.
United Kingdom28 participantsStarted 2020-06-15
Plain-language summary
The purpose of this clinical study is to demonstrate the efficacy of the Erchonia LunulaLaserâ„¢, for the treatment of onychomycosis of the toenail.
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:
* 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
* 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 between 20%-50%
* 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
* Male or female
* 18 years of age or older
Exclusion Criteria:
* Lack of confirmation of the presence of fungal infection through a negative KOH stain finding and/or a negative fungal culture finding
* 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 etiology); specifically visual clinical presentations consistent with one or more of the following:
* Proximal…
What they're measuring
1
Percentage of Participants With Toenails Attaining Complete Cure