N/A
Completed N=15
Human Factors Testing for OTC Use of the Erchonia® LunulaLaser
Onychomycosis
Source: ClinicalTrials.gov NCT05626270 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Human Factors — 15 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Human Factors |
15 | — |
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. Informational only — not medical advice.