Hair RemovalNCT01348776
The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design
A study testing Hair2Go (Mē) in people with Hair Removal, run by Syneron Medical at 4 sites in United States.
Trial summary
The purpose of this study is to determine efficiency of Hair2Go device for short-term and long-term removal of unwanted hair adjunctive to shaving using a before-after study design. 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 (Mē)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2011to 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
- Healthy males and females, between 18 and 65 years of age.
- Subject has Black or dark brown terminal hairs in the areas to be treated.
- Terminal hair density requirement of greater than 15 hairs within the hair count site (3x3 cm area) as determined by manual hair count performed by the study investigator.
- Willing to sign informed consent.
- Willing to follow the treatment schedule and post treatment follow-up.
- Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications
- Willingness to avoid excessive sun exposure two weeks prior to treatments
Who cannot join
- Skin and Hair
- Subjects with white, red, light brown and/ or blonde hairs in the areas to be treated.
- A history of keloidal scarring (hypertrophic scars or keloids).
- Active dermatologic lesion or infection in the treatment site.
- Subject has permanent tattoos or makeup in the treatment area.
- Recently tanned in the area to be treated and/or unable or unlikely to refrain from tanning during the study.
Show all 26Show fewer
- Subject has disease related to photosensitivity, such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc
- Subject has a history of herpes outbreak in the area of treatment, unless receiving preventative treatment from physician
- Other Medical Conditions
- Pregnant, planning to become pregnant, hormone fluctuations and/or breast feeding during the experiment.
- Subjects with Diabetes (Type I or II) or other systemic or metabolic condition
- Subject has an active electrical implant anywhere in the body, such as a pacemaker, an internal defibrillator, insulin pump, incontinence device, etc.
- Subject suffers from epilepsy.
- Subject has active cancer, or has a history of skin cancer or any other cancer in the area to be treated, including presence of malignant or pre-malignant pigmented lesions.
- Subject received radiation therapy or chemotherapy treatments with the past 3 months.
- Subject has known anticoagulative or thromboembolic condition or is on any form of anticoagulation treatment.
- Subject has a history of immunosuppressant/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- Subject has any other condition which in the physician's opinion would make it unsafe for the subject to be treated.
- Medication/treatments
- Subject had rotating type tweezer epilator treatment, or waxing within the last 3 weeks
- 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 within the last 6 months.
- Subject is taking medication known to induce photosensitivity, including non-steroidal anti-inflammatory agents, tetracyclines, phenothiazines, thiazide diuretics, sulfonylureas, sulfonamides, Dacarbazine(DTIC), fluorouracil, vinblastine, and griseofulvin within 4 weeks of therapy.
- Subject has been taking Accutane® within 6 months of therapy.
- Subject has been on steroid regimen during the last three months.
- Subject is on Gold therapy (for arthritis treatment).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dr Jerome Garden
Chicago, Illinois, 60611
Zel Skin and Laser Specialist
Edina, Minnesota, 55435
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
South Coast Dermatology
Tustin, California, 92780
About this study
The purpose of this study is to determine efficiency of Hair2Go device for short-term and long-term removal of unwanted hair adjunctive to shaving using a before-after study design.
Read the detailed description
This study is a multicenter study, designed to determine the efficacy of the Hair2Go hair removal device and to compare the extent of hair removal with and without maintenance treatments. Preferably, two anatomical regions to be treated will be selected including the axilla and either the legs (calves) or forearms. The size of the area treated will be approximately 5x5 cm2. Additional areas including the face can be treated according to the subject's request with the PI's discretion but are not mandatory. Subjects will be provided with the device and will be instructed as to the method of usage. The subjects will be expected to self-administer the treatment at the clinic in a "simulated home environment". The duration of the treatment session is approximately 30-60 minutes. Each of the selected anatomical regions (both left and right sides) will be treated with either low, medium, or high Elōs energy level according to the PI's discretion. However all anatomical regions except for the axilla will be treated with either low or medium elōs energy levels only. Only the axilla will be treated up to an energy of 4J//cm2 A defined area of 5x5 cm2cm2 in the leg will not be treated and will serve as a reference for the temporal changes in hair growth that might be subject to factors, including fluctuations in hormone levels. Both sides (left and right) of the same anatomical region will receive the basic treatments. One side will receive 3 additional maintenance treatments in 4 week intervals ("Maintenance" vs "No maintenance" side) until the end of the experiment. More specifically, the study includes up to 11 visits at the clinic: initial consultation, 7 basic treatments in 1 week intervals followed in one side by 3 maintenance treatments, each 4 weeks apart. Follow ups will be conducted at 4 and 12 weeks after the last basic treatment.
- Conditions
- Hair Removal
- Being tested
- Hair2Go (Mē)
- 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.
Hair2Go (Mē)Device
Also called Mē my elōs
Treatment with Hair2Go Device 7 times every week with maintenance treatments once a month for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Hair2Go (Mē) | Experimental | Subjects treated with Hair2Go (Mē) Device Receives: Device: Hair2Go (Mē) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Clearance 1 Month After Last Treatment
Hair clearance = the percent of hair cleared from baseline to endpoint.
Measured: 3 months (1 month after 7 weekly treatments)
Secondary outcomes (4)
Hair Clearance at 3-month (Final) Follow up
Hair clearance = %hair cleared from baseline to endpoint after 7 weekly treatments with or without additional 2 monthly maintenance treatments.
Measured: 5 months (3 months after 7 weekly treatments)
Occurrence of Anticipated Effects on Skin
As with other IPL devices, subjects were informed that they should expect some sense of warmth, tingling, or itching, when the device was applied. This was anticipated to be mild to moderate. Subjects could also expect transient erythema and edema at the treatment site that usually disappears within 24 hours.
Measured: Up to 19 weeks
Tolerability Level of the Procedure Following Treatments
Gathering information about the tolerability of the procedure following weekly treatments 1, 3, 7 and maintenance treatment 3 by asking subjects to rate the tolerability of the procedure based on 5 point pain scale (no pain, mild pain, moderate pain, severe pain, Intolerable [had to stop treatment]) .
The distribution of the tolerability level is based on the analysis of the areas treated and not on the number of participants since each participant was treated on more than one area. Therefore the number of treated areas exceeds the number of participants and the unit of measurement is % treated areas that were rated.
Measured: 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)
Subject Satisfaction
Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.
Measured: 5 months (final follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMar 2011
- Primary completionJun 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 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 CareMichael Gold, MD, Principal investigator, Tennessee Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348776
- Sponsor's protocol ID
- OHR-2
- Status last verified
- Apr 2013
- First submitted
- 2 May 2011
- Last updated
- 4 Apr 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 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of the Hair2Go Device: A Prospective, Open, Label Study With Before-After Design
- ClinicalTrials.gov ID
- NCT01348776
- Acronym / sponsor ID
- OHR-2
- Conditions
- Hair Removal
- Keywords
- hair reduction, hair removal, hair clearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Posted 4 Apr 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 determine efficiency of Hair2Go device for short-term and long-term removal of unwanted hair adjunctive to shaving using a before-after study design.
Detailed description
This study is a multicenter study, designed to determine the efficacy of the Hair2Go hair removal device and to compare the extent of hair removal with and without maintenance treatments. Preferably, two anatomical regions to be treated will be selected including the axilla and either the legs (calves) or forearms. The size of the area treated will be approximately 5x5 cm2. Additional areas including the face can be treated according to the subject's request with the PI's discretion but are not mandatory. Subjects will be provided with the device and will be instructed as to the method of usage. The subjects will be expected to self-administer the treatment at the clinic in a "simulated home environment". The duration of the treatment session is approximately 30-60 minutes. Each of the selected anatomical regions (both left and right sides) will be treated with either low, medium, or high Elōs energy level according to the PI's discretion. However all anatomical regions except for the axilla will be treated with either low or medium elōs energy levels only. Only the axilla will be treated up to an energy of 4J//cm2 A defined area of 5x5 cm2cm2 in the leg will not be treated and will serve as a reference for the temporal changes in hair growth that might be subject to factors, including fluctuations in hormone levels. Both sides (left and right) of the same anatomical region will receive the basic treatments. One side will receive 3 additional maintenance treatments in 4 week intervals ("Maintenance" vs "No maintenance" side) until the end of the experiment. More specifically, the study includes up to 11 visits at the clinic: initial consultation, 7 basic treatments in 1 week intervals followed in one side by 3 maintenance treatments, each 4 weeks apart. Follow ups will be conducted at 4 and 12 weeks after the last basic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hair2Go (Mē) | Experimental | Device: Hair2Go (Mē)Subjects treated with Hair2Go (Mē) Device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy males and females, between 18 and 65 years of age.
- Subject has Black or dark brown terminal hairs in the areas to be treated.
- Terminal hair density requirement of greater than 15 hairs within the hair count site (3x3 cm area) as determined by manual hair count performed by the study investigator.
- Willing to sign informed consent.
- Willing to follow the treatment schedule and post treatment follow-up.
Key exclusion criteria (26 listed)
- Skin and Hair
- Subjects with white, red, light brown and/ or blonde hairs in the areas to be treated.
- A history of keloidal scarring (hypertrophic scars or keloids).
- Active dermatologic lesion or infection in the treatment site.
- Subject has permanent tattoos or makeup in the treatment area.
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 |
|---|---|---|
| Hair2Go (Mē)Also: Mē my elōsTreatment with Hair2Go Device 7 times every week with maintenance treatments once a month for 3 months | Device | Hair2Go (Mē) |
Primary outcome
Hair Clearance 1 Month After Last Treatment
Time frame: 3 months (1 month after 7 weekly treatments)
Hair clearance = the percent of hair cleared from baseline to endpoint.
4 secondary outcomes
Hair Clearance at 3-month (Final) Follow up
Time frame: 5 months (3 months after 7 weekly treatments)
Occurrence of Anticipated Effects on Skin
Time frame: Up to 19 weeks
Tolerability Level of the Procedure Following Treatments
Time frame: 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)
Subject Satisfaction
Time frame: 5 months (final follow up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 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.
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hair2Go (Mē) in people with Hair Removal, run by Syneron Medical at 4 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 7 inclusion and 26 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 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 4 Apr 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?
Hair Clearance 1 Month After Last Treatment (time frame: 3 months (1 month after 7 weekly treatments)). 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 4 Apr 2013.