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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hair2Go device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hair2Go | Device | Treatment with the device once under observation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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%. | 1 hour |
| Percentage of Participants Performing Critical/Non-critical Errors | Study staff will record the number of errors according to the following:
| 1-2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Caswell, Ph.D. | Consumer Product Testing Company | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consumer Product Testing Company | Fairfield | New Jersey | 07004 | United States |
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The study was conducted at a single site specialized in consumer product testing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hair2Go Device | This group included subjects who participated in the label comprehension phase. From these subjects, 48 subjects self-included in the usability phase (no contraindications) and chose to use the device for 1 treatment. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Label Comprehension Phase |
| |||||||||||||
| Usability Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
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%. | Sample size was discussed with the FDA during a pre-IDE teleconference | Posted | Number | percentage of participants | 1 hour |
This was a single visit study
The label comprehension phase of the study did not involve a treatment with the device. Of the 63 participant of the label comprehension phase, 47 subjects who were not self-excluders continued to the usability phase that included a treatment. Therefore the number of "at risk" individuals is 47 and not the original 63.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hair2Go (Me) Device | The subjects who participated in the label comprehension phase; the majority of whom 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doran Rozen, Director of Clinical Affairs | Syneron Beauty | +972-54-7800260 | Doran.Rozen@syneron.com |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Label Comprehension Group | Subjects that participated in the label comprehension phase of the study |
|
|
| Primary | Percentage of Participants Performing Critical/Non-critical Errors | Study staff will record the number of errors according to the following:
| Subjects who were not self-excluders in the label comprehension phase and consented to continue to the usability phase (product use). | Posted | Number | percentage of participants with errors | 1-2 hours |
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| 0 |
| 47 |
| 0 |
| 47 |
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