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Human Factors Testing for OTC Use of the Erchonia® LunulaLaser

Primary Purpose

Onychomycosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LunulaLaser OTC
Sponsored by
Erchonia Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Onychomycosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erchonia Corporation

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

LunulaLaser OTC

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2022
Last Updated
December 30, 2022
Sponsor
Erchonia Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05626270
Brief Title
Human Factors Testing for OTC Use of the Erchonia® LunulaLaser
Official Title
Human Factors Validation Testing for Over-the-Counter Use of the Erchonia® LunulaLaser™ OTC
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 4, 2021 (Actual)
Primary Completion Date
December 23, 2022 (Actual)
Study Completion Date
December 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erchonia Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LunulaLaser OTC
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
LunulaLaser OTC
Intervention Description
The LunulaLaser™ OTC is a nonthermal and non-invasive procedure designed to restore the growth of clear, healthy nails in clients with onychomycosis.
Primary Outcome Measure Information:
Title
Human Factors
Description
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.
Time Frame
Each study session was completed on a single day, for up to 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Erchonia Corporation
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32904
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Human Factors Testing for OTC Use of the Erchonia® LunulaLaser

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