Hair Removal Clinical Trial
— OHR6-LCUOfficial title:
Evaluating Label Comprehension and Usability of the Hair2Go System
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 |
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.
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. |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Consumer Product Testing Company | Fairfield | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Syneron Medical |
United States,
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 |
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