N/A
N=63
Hair2Go Label Comprehension and Usability Study
Hair Removal
Bottom Line
View on ClinicalTrials.gov: NCT01578187 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders) — 94 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hair2Go (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Syneron Medical
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders) |
94 | — |
| PRIMARY Percentage of Participants Performing Critical/Non-critical Errors |
0; 2.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01578187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.