N/A
N=15
Human Factors Testing for OTC Use of the Erchonia® LunulaLaser
Onychomycosis
Bottom Line
View on ClinicalTrials.gov: NCT05626270 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Human Factors — 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LunulaLaser OTC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Erchonia Corporation
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Human Factors |
15 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18 years or older.
- Male or female.
- Currently employed at a nail salon, beauty salon and/or spa, fitness and wellness spa, or the like.
- In possession of qualification(s), current licensure(s), certification(s), and/or accreditation(s), as applicable, to perform their designated tasks at their place of employment, e.g., cosmetology degree, nail technician, esthetician, massage therapist etc.
- Voluntarily signed consent form.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT05626270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.