Trial Outcomes & Findings for Hair2Go Label Comprehension and Usability Study (NCT NCT01578187)
NCT ID: NCT01578187
Last Updated: 2013-12-25
Results Overview
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%.
COMPLETED
NA
63 participants
1 hour
2013-12-25
Participant Flow
The study was conducted at a single site specialized in consumer product testing.
Participant milestones
| Measure |
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.
|
|---|---|
|
Label Comprehension Phase
STARTED
|
63
|
|
Label Comprehension Phase
COMPLETED
|
63
|
|
Label Comprehension Phase
NOT COMPLETED
|
0
|
|
Usability Phase
STARTED
|
48
|
|
Usability Phase
COMPLETED
|
47
|
|
Usability Phase
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Usability Phase
Withdrawal by Subject
|
1
|
Baseline Characteristics
Hair2Go Label Comprehension and Usability Study
Baseline characteristics by cohort
| Measure |
Hair2Go Device
n=63 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hourPopulation: Sample size was discussed with the FDA during a pre-IDE teleconference
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%.
Outcome measures
| Measure |
Label Comprehension Group
n=63 Participants
Subjects that participated in the label comprehension phase of the study
|
Usability - Non Critical Error
Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event.
|
|---|---|---|
|
Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders)
|
94 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 1-2 hoursPopulation: Subjects who were not self-excluders in the label comprehension phase and consented to continue to the usability phase (product use).
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.
Outcome measures
| Measure |
Label Comprehension Group
n=47 Participants
Subjects that participated in the label comprehension phase of the study
|
Usability - Non Critical Error
n=47 Participants
Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event.
|
|---|---|---|
|
Percentage of Participants Performing Critical/Non-critical Errors
|
0 percentage of participants with errors
|
2.1 percentage of participants with errors
|
Adverse Events
Hair2Go (Me) Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Doran Rozen, Director of Clinical Affairs
Syneron Beauty
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place