Hair2Go Label Comprehension and Usability Study (OHR6-LCU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Syneron Medical
ClinicalTrials.gov Identifier:
NCT01578187
First received: April 13, 2012
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Hair Removal
Device: Hair2Go

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluating Label Comprehension and Usability of the Hair2Go System

Further study details as provided by Syneron Medical:

Primary Outcome Measures:
  • 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:

    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%.


  • 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:

    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.


Enrollment: 63
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hair2Go device Device: Hair2Go
Treatment with the device once under observation
Other Name: Mē my elōs

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578187

Locations
United States, New Jersey
Consumer Product Testing Company
Fairfield, New Jersey, United States, 07004
Sponsors and Collaborators
Syneron Medical
Investigators
Principal Investigator: Michael Caswell, Ph.D. Consumer Product Testing Company
  More Information

No publications provided

Responsible Party: Syneron Medical
ClinicalTrials.gov Identifier: NCT01578187     History of Changes
Other Study ID Numbers: OHR6-LCU
Study First Received: April 13, 2012
Results First Received: April 4, 2013
Last Updated: November 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Syneron Medical:
hair reduction
hair removal
hair clearance

ClinicalTrials.gov processed this record on September 30, 2014