Hair RemovalOHR6-LCUNCT01578187
Hair2Go Label Comprehension and Usability Study
A study testing Hair2Go in people with Hair Removal, run by Syneron Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Removal
- What is being tested?
- Hair2Go
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Consumer Product Testing Company
Fairfield, New Jersey, 07004
About this study
Official title: Evaluating Label Comprehension and Usability of the Hair2Go System
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.
Read the detailed description
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
- Hair Removal
- Being tested
- Hair2Go
- Keywords
- hair reduction, hair removal, hair clearance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair2GoDevice
Also called Mē my elōs
Treatment with the device once under observation
| Study group | Role | What they receive |
|---|---|---|
| Hair2Go device | Experimental | Not described Receives: Device: Hair2Go |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 1 hour
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.
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hair RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Caswell, Ph.D., Principal investigator, Consumer Product Testing Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578187
- Sponsor's protocol ID
- OHR6-LCU
- Acronym
- OHR6-LCU
- Status last verified
- Nov 2013
- First submitted
- 13 Apr 2012
- Last updated
- 25 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Label Comprehension and Usability of the Hair2Go System
- ClinicalTrials.gov ID
- NCT01578187
- Acronym / sponsor ID
- OHR6-LCU / OHR6-LCU
- Conditions
- Hair Removal
- Keywords
- hair reduction, hair removal, hair clearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Posted 11 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hair2Go device | Experimental | Device: Hair2Go |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hair2GoAlso: Mē my elōsTreatment with the device once under observation | Device | Hair2Go device |
Primary outcome
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: 1. Questions regarding safe use of the system. 2. 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: 1. Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence 2. Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Caswell, Ph.D. principal investigator
Consumer Product Testing Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hair2Go in people with Hair Removal, run by Syneron Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders) (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2013.