Hair2Go Label Comprehension and Usability Study (OHR6-LCU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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||Phase|
|Hair Removal||Device: Hair2Go||Not Applicable|
|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|
|Actual Primary Completion Date :||April 2012|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|