Hair2Go Label Comprehension and Usability Study (OHR6-LCU)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Evaluating Label Comprehension and Usability of the Hair2Go System|
- Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders) [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
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:
- Questions regarding safe use of the system.
- 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 [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]
Study staff will record the number of errors according to the following:
- Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence
- Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event.
|Study Start Date:||March 2012|
|Study Completion Date:||June 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
|Experimental: Hair2Go device||
Treatment with the device once under observation
Other Name: Mē my elōs
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578187
|United States, New Jersey|
|Consumer Product Testing Company|
|Fairfield, New Jersey, United States, 07004|
|Principal Investigator:||Michael Caswell, Ph.D.||Consumer Product Testing Company|