Human Factors Testing for OTC Use of the Erchonia® LunulaLaser

NCT05626270 | Completed Results FDA Device

• 1 other identifier: R-FFS-OTC
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

LunulaLaser OTC

OTHER

The user will be presented with the device in its intended packaging as if receiving it at their place of employment. No additional information, instruction or training will be provided by the Study Observer, or any other individual associated with the study. The user will be left to work out how to operate the Erchonia LunulaLaser™ OTC as independently and naturally as possible without interference or influence from the Study Observer. While the user will have received the instructional information in the packaging as in intended use, he or she will not be instructed to use any of the information. It will be up to the user as to if or how he or she chooses to use that information to set up operation of the device as would occur under actual conditions of intended use.

Device: LunulaLaser OTC

Interventions

LunulaLaser OTC DEVICE

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

LunulaLaser OTC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- None

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Erchonia Corporation

Melbourne, Florida, 32904, United States

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Travis Sammons
• Organization: Erchonia Corporation

tsammons@erchonia.com

864-531-0064

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: June 4, 2021
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: May 23, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)