18 and older, any sex, with Onychomycosis of Toenail. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Toenails Attaining Complete CurePrimary· 12 months
Complete Cure criteria is defined as a subject/toenail satisfying both the 'Clinical Cure' and the 'Mycological Cure' criteria in order to be considered a study responder, defined as follows:
(i) Clinical Cure: Measurement of clear nail increase as the following:
* at least 12 mm increase in clear nail of the great toenail, with evidence of distal growth of the affected area, 12 months after the first treatment; or
* complete clearance 12 months after the first treatment if less than 12 mm distal nail was involved prior to treatment.
The response should be progressive in at least 2 sequenti
Group
Value
95% CI
Erchonia LunulaLaser
6
Mycologic CureSecondary· 14 months
Mycological cure is defined as negative culture for dermatophytes using the BioMed InTray™ DM Culture
Group
Value
95% CI
Erchonia LunulaLaser
14
Sponsor's own description
The purpose of this clinical study is to demonstrate the efficacy of the Erchonia LunulaLaser™, for the treatment of onychomycosis of the toenail.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Erchonia Corporation
Last refreshed: 1 August 2025
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