Hair RemovalOHR-8-FU-1YNCT01529931
Long Term Efficiency of the Hair2Go Device
A study testing Hair2Go in people with Hair Removal, run by Syneron Medical at 3 sites in United States.
Trial summary
The current study is a follow up study designed to gather information about the effect of the number of Hair2Go maintenance treatments on hair clearance 1 year after the last basic Hair2Go treatment. This study includes taking photos and documenting endpoints but does not include treatments. 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
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Completed the basic treatments of OHR-2, OHR-3, or OHR-5-Face studies.
- Healthy males and females, between 18 and 65 years of age.
- Willing to sign informed consent.
- Willing to follow the protocol schedule.
- Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications
- Willingness to avoid shaving 1 week prior to the visits.
Who cannot join
- Subject is taking medication that may have effect on hair growth (i.e. hormones, minoxidil)
- Subject had electrolysis treatment within the last 6 months over the treatment area.
- Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment site (with the exception of treatments within the OHR-2, OHR-2P, OHR2-1Y, OHR-3, or OHR-5-Face protocol).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dr Jerome Garden
Chicago, Illinois, 60611
Zel Skin & Laser Specialists
Edina, Minnesota, 55424
South Dermatology Institute
Tustin, California, 92780
About this study
Official title: Follow Up Study: The Effect Of Hair2Go Maintenance Treatments on Long Term Hair Removal
The current study is a follow up study designed to gather information about the effect of the number of Hair2Go maintenance treatments on hair clearance 1 year after the last basic Hair2Go treatment. This study includes taking photos and documenting endpoints but does not include treatments.
Read the detailed description
The Hair2Go device is intended for short-term and long-term removal of unwanted hair adjunctive to shaving. The device uses a technology called Elōs, which is a combination of electrical field at radio frequencies (RF) and intense optical energy, that are simultaneously applied to the tissue and were found to have synergistic effects. Thus, lower levels of both energies are used to facilitate the treatment for individuals of all skin types and hair colors.
This study is a multicenter study. Subjects that completed the basic treatments of previous Hair2Go studies (OHR-2, OHR-3, or OHR-5-Face) will be offered the option to enroll in this study that will not include treatments. The individual data collected in the OHR-2 (and its extensions, i.e. OHR2-P and OHR2-1Y), OHR-3, and OHR-5-Face studies will be used for the analysis together with data gathered in this study. Photographs of the previously treated areas will be taken 3, 6, 9, and 12 months after the last basic treatment if they were not already taken as part of the OHR-2, one of its extensions (i.e. OHR2-P and OHR2-1Y), or OHR-5-Face.
- Conditions
- Hair Removal
- Being tested
- Hair2Go
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
Hair2Go treatment once a month for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Maintenance | Experimental | This arm receives Hair2Go treatments once a month for 6 months Receives: Device: Hair2Go |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair clearance at final follow up
Hair clearance will be calculated at the final follow-up treatment from the hair counts conducted by independent blinded reviewer(s) based on photographs of treatment sites.
Measured: 1 year after last basic treatment (termination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerome M Garden, MD, Principal investigator, Northwestern Memorial HospitalVince Afsahi, MD, Principal investigator, South Coast Dermatology InstituteBrian D Zelickson, MD, Principal investigator, Abbot Northwestern Hospital Center for Cosmetic CareLilach Gavish, PhD, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529931
- Sponsor's protocol ID
- OHR-8-FU-1Y
- Other IDs
- DC83411
- Acronym
- OHR-8-FU-1Y
- Status last verified
- Jan 2019
- First submitted
- 6 Feb 2012
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: Only 5 subjects enrolled into this protocol. Data was combined with OHR2-1Y protocol and reported under that study.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow Up Study: The Effect Of Hair2Go Maintenance Treatments on Long Term Hair Removal
- ClinicalTrials.gov ID
- NCT01529931
- Acronym / sponsor ID
- OHR-8-FU-1Y / OHR-8-FU-1Y
- Conditions
- Hair Removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study is a follow up study designed to gather information about the effect of the number of Hair2Go maintenance treatments on hair clearance 1 year after the last basic Hair2Go treatment. This study includes taking photos and documenting endpoints but does not include treatments.
Detailed description
The Hair2Go device is intended for short-term and long-term removal of unwanted hair adjunctive to shaving. The device uses a technology called Elōs, which is a combination of electrical field at radio frequencies (RF) and intense optical energy, that are simultaneously applied to the tissue and were found to have synergistic effects. Thus, lower levels of both energies are used to facilitate the treatment for individuals of all skin types and hair colors.
This study is a multicenter study. Subjects that completed the basic treatments of previous Hair2Go studies (OHR-2, OHR-3, or OHR-5-Face) will be offered the option to enroll in this study that will not include treatments. The individual data collected in the OHR-2 (and its extensions, i.e. OHR2-P and OHR2-1Y), OHR-3, and OHR-5-Face studies will be used for the analysis together with data gathered in this study. Photographs of the previously treated areas will be taken 3, 6, 9, and 12 months after the last basic treatment if they were not already taken as part of the OHR-2, one of its extensions (i.e. OHR2-P and OHR2-1Y), or OHR-5-Face.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance | Experimental | Device: Hair2GoThis arm receives Hair2Go treatments once a month for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Completed the basic treatments of OHR-2, OHR-3, or OHR-5-Face studies.
- Healthy males and females, between 18 and 65 years of age.
- Willing to sign informed consent.
- Willing to follow the protocol schedule.
- Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications
Key exclusion criteria (3 listed)
- Subject is taking medication that may have effect on hair growth (i.e. hormones, minoxidil)
- Subject had electrolysis treatment within the last 6 months over the treatment area.
- Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment site (with the exception of treatments within the OHR-2, OHR-2P, OHR2-1Y, OHR-3, or OHR-5-Face protocol).
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 elōsHair2Go treatment once a month for 6 months | Device | Maintenance |
Primary outcome
Hair clearance at final follow up
Time frame: 1 year after last basic treatment (termination)
Hair clearance will be calculated at the final follow-up treatment from the hair counts conducted by independent blinded reviewer(s) based on photographs of treatment sites.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Individual participant dataSharing planned: No. Only 5 subjects enrolled into this protocol. Data was combined with OHR2-1Y protocol and reported under that study.
Related trials for Hair Removal
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Recruiting
Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color
Pilonidal Disease
Not yet recruiting
Vacuum-Assisted Clipper in Preoperative Hair Removal: Effects on Contamination and Skin Integrity
Microbial Contamination, Environmental Contamination
Not yet recruiting
Evidence-Based Integrated Protocol to Maximize Hair Follicle Survival in Follicular Unit Extraction (FUE)
Androgenetic Alopecia, Cicatricial Alopecia
Not yet recruiting
Hair Regrowth Following Partial Thickness Removal of SSCIS
Squamous Cell Carcinoma (Skin), Squamous Cell Carcinoma in Situ
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.
Jerome M Garden, MD principal investigator
Northwestern Memorial Hospital
Vince Afsahi, MD principal investigator
South Coast Dermatology Institute
Brian D Zelickson, MD principal investigator
Abbot Northwestern Hospital Center for Cosmetic Care
3 sites 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 3 sites 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 6 inclusion and 3 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 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hair clearance at final follow up (time frame: 1 year after last basic treatment (termination)). 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 18 Jan 2019.