Human Factors Testing for OTC Use of the Erchonia® LunulaLaser

Onychomycosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05626270
• Other study ID #: R-FFS-OTC
• Status: Completed
• Phase: N/A
• Start date: June 4, 2021
• Est. completion date: December 23, 2022

Study information

• Verified date: February 2024
• Source: Erchonia Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Device:
• LunulaLaser OTC
The LunulaLaser™ OTC is a nonthermal and non-invasive procedure designed to restore the growth of clear, healthy nails in clients with onychomycosis.

Locations

Country	Name	City	State
United States	Erchonia Corporation	Melbourne	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Erchonia Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Human Factors	The outcome measure identifies the number of subject users that were defined as a study "pass".; A subject user is determined a study 'pass if the subject satisfactorily completes both the device setup and treatment procedure. If the subject user does not satisfactorily complete either one or both of device setup and/or treatment procedure the subject will be determined a study "fail".	Each study session was completed on a single day, for up to 120 minutes