Hair Removal
Conditions
Keywords
hair reduction, hair removal, hair clearance
Brief summary
The purpose of this study is to test label comprehension and usability of the hair removal device in 60 male and female participants. The study population will represent the US demographic distribution of skin types and will include varying levels of literacy.
Detailed description
This will be a single-visit study consisting of two phases: Phase I - assessing label comprehension and Phase II - usability. For Phase I, subjects will be asked to review the outer packaging of the mē device. Each subject will be taken through an interview which will evaluate messages on the external product labeling regarding product use and self-selection criteria. Subjects, who are not self-excluders and/or contraindicated for use of the device will continue with Phase II of the study. This usability phase will consist of watching the instructional DVD, reading the User Guide and then performing a skin sensitivity test. Subjects will be expected to self-administer the hair removal treatment in a simulated home-use environment under observation of the study personnel. The users will have a telephone in the room and may call a phone number and request assistance while performing the treatment, simulating the toll-free hotline that will be available to consumers in commercial use.
Interventions
DEVICEHair2Go
Treatment with the device once under observation
Sponsors
Syneron Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females, between 18 and 65 years of age. 2. Able to read and understand the written consent form. 3. Willing to sign informed consent. 4. Able to read and speak English. 5. Willing and able to participate in the study procedures.
Exclusion criteria
1. The participant or anyone in their household is currently employed by a marketing research department or company, an advertising agency or public relations firm, a pharmaceutical company, a healthcare device manufacturer, a cosmetic or personal care company. 2. The participant is currently employed at a salon, day spa or beauty school/college as a stylist, barber, esthetician or beauty instructor. 3. The respondent has ever been trained or employed as a healthcare professional. 4. The participant normally wears corrective lenses, contacts or glasses to read and does not bring them with him/her to the study site. 5. The participant has participated in any market research study, product label study or clinical trial in the past thirty (30) days. 6. Non-English speakers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders) | 1 hour | Label comprehension will be based on responses to a questionnaire. Questions will be based on a tiered system by level of importance in responding correctly according to the following: 1. Questions regarding safe use of the system. 2. Questions regarding correct use of the system(not related to safety). In order to demonstrate how well the label instruction, as a whole, was understood by all subjects, the proportion of subjects who correctly understood the label as a whole was calculated by classifying each subject as either a responder or non-responder based on the following criteria regarding all questions: A subject was considered a responder if he/she correctly answered 11/12 questions related to safety AND 5/6 low category questions not related to safety. The study was considered a success if the response rate (i.e., the proportion of subjects correctly understanding the label based on the responder criteria) was at least 90%. |
| Percentage of Participants Performing Critical/Non-critical Errors | 1-2 hours | Study staff will record the number of errors according to the following: 1. Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence 2. Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at a single site specialized in consumer product testing.
Participants by arm
| Arm | Count |
|---|---|
| Hair2Go Device The subjects who participated in the label comprehension phase, of them most participated in the usability phase. The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM)test. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Usability Phase | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Hair2Go Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants |
| Age, Continuous | 42 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 63 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
Percentage of Participants Performing Critical/Non-critical Errors
Study staff will record the number of errors according to the following: 1. Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence 2. Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event.
Time frame: 1-2 hours
Population: Subjects who were not self-excluders in the label comprehension phase and consented to continue to the usability phase (product use).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Label Comprehension Group | Percentage of Participants Performing Critical/Non-critical Errors | 0 percentage of participants with errors |
| Usability - Non Critical Error | Percentage of Participants Performing Critical/Non-critical Errors | 2.1 percentage of participants with errors |
Primary
Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders)
Label comprehension will be based on responses to a questionnaire. Questions will be based on a tiered system by level of importance in responding correctly according to the following: 1. Questions regarding safe use of the system. 2. Questions regarding correct use of the system(not related to safety). In order to demonstrate how well the label instruction, as a whole, was understood by all subjects, the proportion of subjects who correctly understood the label as a whole was calculated by classifying each subject as either a responder or non-responder based on the following criteria regarding all questions: A subject was considered a responder if he/she correctly answered 11/12 questions related to safety AND 5/6 low category questions not related to safety. The study was considered a success if the response rate (i.e., the proportion of subjects correctly understanding the label based on the responder criteria) was at least 90%.
Time frame: 1 hour
Population: Sample size was discussed with the FDA during a pre-IDE teleconference
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Label Comprehension Group | Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders) | 94 percentage of participants |