Onychomycosis
Conditions
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.
Interventions
DEVICELunulaLaser OTC
The LunulaLaser™ OTC is a nonthermal and non-invasive procedure designed to restore the growth of clear, healthy nails in clients with onychomycosis.
Sponsors
Erchonia Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Factors | Each study session was completed on a single day, for up to 120 minutes | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LunulaLaser OTC 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | LunulaLaser OTC |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 40.13 years STANDARD_DEVIATION 10.56 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: Each study session was completed on a single day, for up to 120 minutes
Population: Number of subject users that were defined as a study pass.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LunulaLaser OTC | Human Factors | 15 participants |