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Hair2Go Label Comprehension and Usability Study

NCT ID: NCT01578187

Last Updated: 2013-12-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Hair Removal

Keywords

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hair reduction hair removal hair clearance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Hair2Go device

Group Type EXPERIMENTAL

Hair2Go

Intervention Type DEVICE

Treatment with the device once under observation

Interventions

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Hair2Go

Treatment with the device once under observation

Intervention Type DEVICE

Other Intervention Names

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Mē my elōs

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Syneron Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Caswell, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Consumer Product Testing Company

Locations

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Consumer Product Testing Company

Fairfield, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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OHR6-LCU

Identifier Type: -

Identifier Source: org_study_id