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Hair2Go Label Comprehension and Usability Study (OHR6-LCU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01578187
First Posted: April 16, 2012
Last Update Posted: December 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Syneron Medical
April 13, 2012
April 16, 2012
April 4, 2013
October 11, 2013
December 25, 2013
March 2012
April 2012   (Final data collection date for primary outcome measure)
  • Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders) [ Time Frame: 1 hour ]

    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 ]

    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.
Not Provided
Complete list of historical versions of study NCT01578187 on ClinicalTrials.gov Archive Site
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Hair2Go Label Comprehension and Usability Study
Evaluating Label Comprehension and Usability of the Hair2Go System
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Hair Removal
Device: Hair2Go
Treatment with the device once under observation
Other Name: Mē my elōs
Experimental: Hair2Go device
Intervention: Device: Hair2Go
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
June 2012
April 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01578187
OHR6-LCU
Yes
Not Provided
Not Provided
Syneron Medical
Syneron Medical
Not Provided
Principal Investigator: Michael Caswell, Ph.D. Consumer Product Testing Company
Syneron Medical
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP