Hair2Go Label Comprehension and Usability Study

Hair Removal Clinical Trial

— OHR6-LCU  

Official title:

Evaluating Label Comprehension and Usability of the Hair2Go System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578187
• Other study ID #: OHR6-LCU
• Status: Completed
• Phase: N/A
• First received: April 13, 2012
• Last updated: November 27, 2013
• Start date: March 2012
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: Syneron Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hair Removal

Intervention

Device:
• Hair2Go
Treatment with the device once under observation

Locations

Country	Name	City	State
United States	Consumer Product Testing Company	Fairfield	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Syneron Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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: 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%.	1 hour	No
Primary	Percentage of Participants Performing Critical/Non-critical Errors	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.	1-2 hours	No