Human Factors Testing for OTC Use of the Erchonia® LunulaLaser

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is an uncontrolled simulated-use human factors validation testing design 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. The study design is comprehensive in scope and conducted in a manner such that the results will be able to be generalized to the actual intended user and client population under intended conditions of actual use and be adequately sensitive to capture use errors arising from either the user interface design and/or the instructional and informative materials. Study data will be collected in a manner that will facilitate analysis of the root causes of use errors or problems during the testing.

Official Title
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Human Factors Validation Testing for Over-the-Counter Use of the Erchonia® LunulaLaser™ OTC

Conditions
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Onychomycosis

Intervention / Treatment
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* Device: LunulaLaser OTC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LunulaLaser OTC<br> | Device: LunulaLaser OTC<br>* The LunulaLaser™ OTC is a nonthermal and non-invasive procedure designed to restore the growth of clear, healthy nails in clients with onychomycosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human Factors | A subject user in this study will be considered as either a study 'pass' or a study 'fail,' defined as follows: Study Pass: A subject user who satisfactorily completes both the device setup and treatment procedure will be determined a Study Pass. Study Fail: A subject user who does not satisfactorily complete either one or both of device setup and/or treatment procedure will be determined a Study Fail. | Each study session was completed on a single day, for up to 120 minutes |