Hair2Go Label Comprehension and Usability Study

NCT01578187 | Completed Results DMC

• 1 other identifier: OHR6-LCU
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Hair Removal

Keywords

hair reduction; hair removal; hair clearance

Outcome Measures

Primary Outcomes (2)

• 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: 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%.

  1 hour

• Percentage of Participants Performing Critical/Non-critical Errors

  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.

  1-2 hours

Study Arms (1)

Hair2Go device

EXPERIMENTAL

Device: Hair2Go

Interventions

Hair2Go DEVICE

Treatment with the device once under observation

Also known as: Mē my elōs

Hair2Go device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, between 18 and 65 years of age.
• Able to read and understand the written consent form.
• Willing to sign informed consent.
• Able to read and speak English.
• Willing and able to participate in the study procedures.

You may not qualify if:

• 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.
• The participant is currently employed at a salon, day spa or beauty school/college as a stylist, barber, esthetician or beauty instructor.
• The respondent has ever been trained or employed as a healthcare professional.
• The participant normally wears corrective lenses, contacts or glasses to read and does not bring them with him/her to the study site.
• The participant has participated in any market research study, product label study or clinical trial in the past thirty (30) days.
• Non-English speakers.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (1)

Consumer Product Testing Company

Fairfield, New Jersey, 07004, United States

Location

Results Point of Contact

• Title: Doran Rozen, Director of Clinical Affairs
• Organization: Syneron Beauty

Doran.Rozen@syneron.com

+972-54-7800260

Study Officials

• Michael Caswell, Ph.D.

  Consumer Product Testing Company

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 16, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 25, 2013
• Results First Posted: October 11, 2013

Record last verified: 2013-11

Locations

US (1)