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.
Sponsor:
Syneron Medical
Information provided by (Responsible Party):
Syneron Medical
