Hair2Go Label Comprehension and Usability Study (OHR6-LCU)
|ClinicalTrials.gov Identifier: NCT01578187|
Recruitment Status : Completed
First Posted : April 16, 2012
Results First Posted : October 11, 2013
Last Update Posted : December 25, 2013
|Condition or disease||Intervention/treatment|
|Hair Removal||Device: Hair2Go|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating Label Comprehension and Usability of the Hair2Go System|
|Study Start Date :||March 2012|
|Primary Completion Date :||April 2012|
|Study Completion Date :||June 2012|
|Experimental: Hair2Go device||
Treatment with the device once under observation
Other Name: Mē my elōs
- 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:
- 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%.
- 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:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578187
|United States, New Jersey|
|Consumer Product Testing Company|
|Fairfield, New Jersey, United States, 07004|
|Principal Investigator:||Michael Caswell, Ph.D.||Consumer Product Testing Company|