At a glance
ClinicalIndex Comparison RecordN/ACompleted· 15 enrolled
Drug / intervention
LunulaLaser OTCdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Human Factors Validation Testing for Over-the-Counter Use of the Erchonia® LunulaLaser™ OTC
In Brief
A clinical study evaluating LunulaLaser OTC for Onychomycosis. Completed, enrolled 15 participants across 1 site.
Detailed Summary
Human factors validation testing to assess the intended user's ability to correctly, safely, and effectively set-up, activate and operate the LunulaLaser™ OTC, to administer a treatment to a suitably qualified client, and to understand the information contained in the Erchonia LunulaLaser™ OTC Installation and Proper Use Reference Guide and box labeling.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOnychomycosis
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20222023202420252026
Enrollment StartJun 2021
First PostedNov 2022
Primary CompletionDec 2022
TodayJul 2026
First PostedNov 23, 2022
Enrollment StartJun 4, 2021
Primary CompletionDec 23, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.6 years ago
Interventions
LunulaLaser OTCdevice
The LunulaLaser™ OTC is a nonthermal and non-invasive procedure designed to restore the growth of clear, healthy nails in clients with onychomycosis.