Hair RemovalOHR2-MeMiniNCT02912013
The Efficacy of the Me Mini Device for Hair Removal
A study testing Me Mini in people with Hair Removal, run by Iluminage Ltd. at 1 site in Israel.
Trial summary
The Mē Mini is a compact version of the Mē device that was cleared by the FDA for removal of unwanted hair and for permanent hair reduction for all skin colors (Fitzpatrick skin photo-types I-VI) based on a series of multi-site clinical studies. 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?
- Me Mini
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2017to 1 Mar 2018
- 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
- 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 and willing to sign the photo-release form.
- 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.
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- 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 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.
- 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).
- Subjects who have participated in any clinical study within the 30 days prior to the first planned treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of the Me Mini Device for Hair Removal: A Prospective, Open Label Study With Before-After Design
The Mē Mini is a compact version of the Mē device that was cleared by the FDA for removal of unwanted hair and for permanent hair reduction for all skin colors (Fitzpatrick skin photo-types I-VI) based on a series of multi-site clinical studies.
The purpose of this post-marketing study is to support the claims for removal of unwanted hair and for permanent hair reduction in the compact version of the device.
Read the detailed description
The purpose of this post-marketing study is to determine the efficacy of the mē mini hair removal device and to compare the extent of hair removal with and without maintenance treatments.
Healthy females, with dark hair in the treatment areas that desire to remove their hair will be enrolled. 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". Subjects will receive 7 "basic treatments" in weekly intervals and 3 additional maintenance treatments on 1 side in 1 month intervals ("Maintenance" vs "No maintenance" side). In the second phase of the study subjects that consented to and completed the first phase will be offered the option to continue with 9 additional maintenance treatments in 1 month intervals.
Follow ups will be conducted at 1, 3, 6, 9, and 12 months after the last basic treatment.
Evaluations will include hair clearance, skin safety, tolerability of the procedure, and subject, satisfaction.
- Conditions
- Hair Removal
- Being tested
- Me Mini
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Me MiniDevice
Home use hair removal device
| Study group | Role | What they receive |
|---|---|---|
| Me mini | Experimental | Subjects treated with Me mini device Receives: Device: Me Mini |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Clearance at 1 Month Follow up
Hair clearance = the percent of hair cleared from baseline to endpoint.
Measured: 3 months after beginning of the study (1 month after completion of 7 weekly treatments that last 2 months)
Secondary outcomes (4)
Hair Clearance at 3-month (Final) Follow up
Hair clearance = the percent of hair cleared from baseline to endpoint.
Measured: 5 months after beginning of the study (3 months after completion of 7 weekly treatments that last 2 months)
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: 1 year and 2 months (throughout the study)
Tolerability Level of the Procedure Following Treatments
Tolerability was rated by the subjects using a 5 point pain scale (no pain, mild pain, moderate pain, severe pain, Intolerable [had to stop treatment]).
Measured: 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5, 8, 11, 14 months (maintenance monthly treatment#3, 6, 9, 12)
Subject Satisfaction
Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.
Measured: 5, 8, 11, and 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start1 Feb 2017
- Primary completion3 Nov 2017
- Study completion1 Mar 2018
Why it stopped: Recruitment rate was not sufficient
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iluminage Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David J Friedman, MD, Principal investigator, Friedman Laser & Skin CenterLilach Gavish, PhD, Study director, HUJI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912013
- Sponsor's protocol ID
- 303-17
- Acronym
- OHR2-MeMini
- Status last verified
- Mar 2018
- First submitted
- 17 Sep 2016
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Me Mini Device for Hair Removal: A Prospective, Open Label Study With Before-After Design
- ClinicalTrials.gov ID
- NCT02912013
- Acronym / sponsor ID
- OHR2-MeMini / 303-17
- Conditions
- Hair Removal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment rate was not sufficient
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Iluminage Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 23 Sep 2016 (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 Mē Mini is a compact version of the Mē device that was cleared by the FDA for removal of unwanted hair and for permanent hair reduction for all skin colors (Fitzpatrick skin photo-types I-VI) based on a series of multi-site clinical studies.
The purpose of this post-marketing study is to support the claims for removal of unwanted hair and for permanent hair reduction in the compact version of the device.
Detailed description
The purpose of this post-marketing study is to determine the efficacy of the mē mini hair removal device and to compare the extent of hair removal with and without maintenance treatments.
Healthy females, with dark hair in the treatment areas that desire to remove their hair will be enrolled. 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". Subjects will receive 7 "basic treatments" in weekly intervals and 3 additional maintenance treatments on 1 side in 1 month intervals ("Maintenance" vs "No maintenance" side). In the second phase of the study subjects that consented to and completed the first phase will be offered the option to continue with 9 additional maintenance treatments in 1 month intervals.
Follow ups will be conducted at 1, 3, 6, 9, and 12 months after the last basic treatment.
Evaluations will include hair clearance, skin safety, tolerability of the procedure, and subject, satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Me mini | Experimental | Device: Me MiniSubjects treated with Me mini 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 |
|---|---|---|
| Me MiniHome use hair removal device | Device | Me mini |
Primary outcome
Hair Clearance at 1 Month Follow up
Time frame: 3 months after beginning of the study (1 month after completion of 7 weekly treatments that last 2 months)
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 after beginning of the study (3 months after completion of 7 weekly treatments that last 2 months)
Occurrence of Anticipated Effects on Skin
Time frame: 1 year and 2 months (throughout the study)
Tolerability Level of the Procedure Following Treatments
Time frame: 1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5, 8, 11, 14 months (maintenance monthly treatment#3, 6, 9, 12)
Subject Satisfaction
Time frame: 5, 8, 11, and 14 months
Results and safety
The study was stopped early (reason given: Recruitment rate was not sufficient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Individual participant dataSharing planned: No
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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.
David J Friedman, MD principal investigator
Friedman Laser & Skin Center
Lilach Gavish, PhD study director
HUJI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Me Mini in people with Hair Removal, run by Iluminage Ltd. at 1 site in Israel.
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: stopped early, as of the sponsor's last update on 9 Mar 2018. 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 Israel. 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 was stopped early (reason given: Recruitment rate was not sufficient). Results are not available in the source record.
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 1 Month Follow up (time frame: 3 months after beginning of the study (1 month after completion of 7 weekly treatments that last 2 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 9 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.