Hair RemovalOHR-3NCT01348789
Safety for Frequent Use Conditions of Hair Removal Device
A study testing Hair2Go (Mē) in people with Hair Removal, run by Syneron Medical at 1 site in United States.
Trial summary
To measure the safety of hair removal device when used frequently. 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
- 37 participants
- Where
- 1 siteUnited 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.
- 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 treatments
Who cannot join
- 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.
- 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
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- 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.
- Subject had rotating type tweezer epilator treatment, or waxing within the last 3 months
- 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.
- Participation in a study of another device or drug within 1 month prior to enrollment or during this study.
- 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
1 site in 1 country.
United States1 site
Physician Laser and Dermatology Institute
Chicago, Illinois, 60611
About this study
Official title: Safety of Hair2Go Device in Frequent Use Conditions: A Prospective, Open Label Study With Before-After Design
To measure the safety of hair removal device when used frequently.
Read the detailed description
The primary endpoint of this study is to measure the safety of the Hair2Go device when used frequently. The secondary endpoints include the kinetics of the hair clearance up to 8 weeks after the last treatment, and gathering information about the pain associated with the procedure
- Conditions
- Hair Removal
- Being tested
- Hair2Go (Mē)
- Keywords
- Hair removal, Hair Clearance, Epilation
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 (Mē) three times every 2-4 days
| Study group | Role | What they receive |
|---|---|---|
| Hair2Go (Mē) | Experimental | Treatment 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.
Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events.
The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes:
- Presence of transient (disappearing < 24 hours) or prolonged erythema
- Presence of transient (disappearing < 24 hours) or prolonged edema
- Self-limited bleeding from mechanical shaving
- Blister formation
- Ulcer formation
- Pigment changes (hypo/hyper)
- Textural changes
- Scarring
- Infection
- Pruritis
- Post inflammation reactions
- Allergic reaction
The safety of the device will be confirmed if no device related serious adverse event will occur.
Measured: Up to 3 months
Secondary outcomes (2)
Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin.
Subject self-report of the tolerability of the procedure (no pain, mild pain, moderate pain) after each of the treatments (#1, #2, #3)separately for relatively light and dark skin photo-types (I-IV and V-VI respectively according to Fitzpatrick skin photo-type classification)
Measured: 0, 3, 7 days (after treatment #1, #2, and #3 respectively)
Hair Clearance
Hair Clearance = the percent of hair cleared from baseline to follow up
Measured: 8 weeks after last treatment
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
- 37 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348789
- Sponsor's protocol ID
- OHR-3
- Acronym
- OHR-3
- Status last verified
- Feb 2013
- First submitted
- 4 May 2011
- Last updated
- 18 Feb 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 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Hair2Go Device in Frequent Use Conditions: A Prospective, Open Label Study With Before-After Design
- ClinicalTrials.gov ID
- NCT01348789
- Acronym / sponsor ID
- OHR-3 / OHR-3
- Conditions
- Hair Removal
- Keywords
- Hair removal, Hair Clearance, Epilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 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 18 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To measure the safety of hair removal device when used frequently.
Detailed description
The primary endpoint of this study is to measure the safety of the Hair2Go device when used frequently. The secondary endpoints include the kinetics of the hair clearance up to 8 weeks after the last treatment, and gathering information about the pain associated with the procedure
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)Treatment 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 (5 listed)
- Healthy males and females, between 18 and 65 years of age.
- 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 treatments
Key exclusion criteria (23 listed)
- 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.
- Subject has disease related to photosensitivity, such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc
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 (Mē) three times every 2-4 days | Device | Hair2Go (Mē) |
Primary outcome
Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events.
Time frame: Up to 3 months
The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes: * Presence of transient (disappearing < 24 hours) or prolonged erythema * Presence of transient (disappearing < 24 hours) or prolonged edema * Self-limited bleeding from mechanical shaving * Blister formation * Ulcer formation * Pigment changes (hypo/hyper) * Textural changes * Scarring * Infection * Pruritis * Post inflammation reactions * Allergic reaction The safety of the device will be confirmed if no device related serious adverse event will occur.
2 secondary outcomes
Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin.
Time frame: 0, 3, 7 days (after treatment #1, #2, and #3 respectively)
Hair Clearance
Time frame: 8 weeks after last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 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
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 (Mē) 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 23 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 Feb 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 18 Feb 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?
Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events. (time frame: Up to 3 months). 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 Feb 2013.