Clinical trial NCT01578187: Hair2Go Label Comprehension and Usability Study
Official title: Evaluating Label Comprehension and Usability of the Hair2Go System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Removal
Keywords: hair reduction
hair removal
hair clearance
Lead sponsor: Syneron Medical
Sponsor class: INDUSTRY
First posted: 2012-04-16
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders)
timeFrame: 1 hour
measure: Percentage of Participants Performing Critical/Non-critical Errors
timeFrame: 1-2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Consumer Product Testing Company
state: New Jersey
Study officials:
affiliation: Consumer Product Testing Company
name: Michael Caswell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: