Skin AgingSR3-MeNCT02902718
MĒ Device for At-Home Skin Rejuvenation
A study testing mē in people with Skin Aging and Skin Rejuvenation, run by Iluminage Ltd. at 1 site in Israel.
Trial summary
The purpose of this pilot study is to evaluate the feasibility of the Mē device for at home facial skin rejuvenation. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Skin Rejuvenation
- What is being tested?
- mē
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Feb 2017to Dec 2017
- 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 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female between the ages of 25 and 60.
- Willing to sign Informed consent form and photo release form.
- Having visible lines and wrinkles in the peri-orbital and peri-oral region of the face (Fitzpatrick elastosis degree 3-6).
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
- Agree to make no changes in their existing skincare regime, other than use of the study products, during the study period.
- If female, must be either post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence).
Who cannot join
- Subjects who currently use or have used in the prior 30 days any skin products that contain alpha hydroxy acids (AHA) e.g. glycolic, lactic, citric, or mandelic acid containing products or retinol/tretinoin containing products or exfoliating washes, masks or scrubs or other micro-dermabrasion skin care products on the treatment areas.
- Subjects who are unwilling to maintain their daily skin care regimen for the duration of the study.
- Subjects who have any skin pathology or condition that could interfere with the evaluation i.e. personal or family history of skin cancer, rosacea and/or requires the use of interfering topical or systemic therapies.
- Subjects with synthetic or metal implants or permanent cosmetic tattoos in the test areas.
- Subjects who have a history of abnormal scarring, e.g. keloids or have significant scarring in the areas to be treated.
- Subjects with bleeding disorders or taking anticoagulation medications, including heavy use of aspirin.
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- Subjects who have participated in any clinical investigation involving the face within the 30 days prior to the first planned treatment or subjects who plan to participate in concomitant facial studies during this trial.
- Subjects, who are pregnant, were pregnant or gave birth in the last 3 months, are currently breast feeding, or might become pregnant during the course of the study.
- Subjects who have a history of light triggered seizures.
- Subjects with prior use of neurotoxins e.g. Botox®, collagen, fat injections and/ or other methods of skin augmentation (enhancement with injected or implanted material) of the face or having had chemical peels within 6 months of initial laser application or planning to so during the course of the study.
- Subject's use of oral isotretinoin (Accutane®) within 12 months of initial device application or during the course of the study.
- Subjects having had facial skin treatments with any professional laser, light based, radiofrequency or other devices within the last year.
- Subjects ever having facial skin treatments with home use laser, light based or radiofrequency or other devices, i.e. PaloVia® or Tria®.
- Subjects with facial plastic surgery within the last 12 months of the initial laser application or planning to do so during the course of the study.
- Subjects who have had sun exposure or used a tanning bed 4 weeks prior to the start of the study.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Friedman Skin & Laser Center
Jerusalem, Israel
Noa Makhervax, +972-52-8874799, noa.clinict@gmail.com
David J Friedman, MD
About this study
Official title: Evaluation of the Safety and Efficacy of the Mē Device for At-Home Skin Rejuvenation Treatment - A Pilot Study
The purpose of this pilot study is to evaluate the feasibility of the Mē device for at home facial skin rejuvenation.
Read the detailed description
The mē home use device is an FDA approved device for hair removal on all skin types and body regions including the face. The device uses Elōs technology 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. Elōs technology has been used at the clinic for non-ablative skin rejuvenation. The levels of Elōs energy used with the professional devices at the clinic is much higher than the level of energy used by the mē device for home use. The current study was designed to evaluate the safety and efficacy of the mē device for home-use non-ablative skin rejuvenation. Healthy female volunteers, seeking facial skin rejuvenation treatment will be enrolled.
The study includes up to 7 visits at the clinic. The defined areas for treatment are one or more facial sub areas (e.g., forehead, peri-orbital, cheeks, peri oral). Subjects will be provided with the device and will be instructed as to the method of usage. The subjects will perform treatments at the clinic and at home according to the schedule detailed in the intervention section. Follow ups will take place at the 1 and 2 months visits. Optional additional follow up visits will take place 3 and 6 months after the initial treatment. Evaluations will include skin safety, tolerability of the procedure, improvement assessment by the study doctor and subject, satisfaction. Optionally, before/after pictures of follow-up visits vs baseline will be sent to blinded evaluators.
- Conditions
- Skin Aging, Skin Rejuvenation
- Being tested
- mē
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mēDevice
The mē device will be used for self administered facial treatments that will be repeated up to 3 times every session. The duration of a treatment session is 5-10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| mē device | Experimental | The subjects will perform treatments with the mē device at the clinic under the supervision of the study personnel at the baseline visit, 1 week and 2 week visits, and 1 month and 2 month visits. In addition the subject will be expected to perform treatments at home according to the following schedule: daily treatments at home for 5 days a week during the first month, followed by 2 treatments a week during the 2nd month, and optionally 1 time a week during the 3rd month. Receives: Device: mē |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in treated area appearance compared to baseline scored by the physician
Improvement will be scored by the physician using the Fitzpatrick classification of skin elastosis (FES) and the global esthetic improvement (GAI) scale in 6 categories including 1) fine lines/ wrinkles; 2) brightness; 3) tightness; 4) texture; 5) pigment; 6) overall improvement using a 5-point Likert scale where 0 represents no change and 4 represents significantly marked improvement
Measured: 1 month
Secondary outcomes (1)
Improvement in treated area appearance compared to baseline scored by the subject
Improvement will be scored by the subject using the global esthetic improvement (GAI) scale in 6 categories including
- fine lines/ wrinkles; 2) brightness; 3) tightness; 4) texture; 5) pigment; 6) overall improvement using a 5-point Likert scale where 0 represents no change and 4 represents significantly marked improvement
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start28 Feb 2017
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- 10 participants (estimated)
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
- NCT02902718
- Sponsor's protocol ID
- 300-16
- Acronym
- SR3-Me
- Status last verified
- Feb 2017
- First submitted
- 12 Sep 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of the Mē Device for At-Home Skin Rejuvenation Treatment - A Pilot Study
- ClinicalTrials.gov ID
- NCT02902718
- Acronym / sponsor ID
- SR3-Me / 300-16
- Conditions
- Skin Aging, Skin Rejuvenation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Iluminage Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 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 purpose of this pilot study is to evaluate the feasibility of the Mē device for at home facial skin rejuvenation.
Detailed description
The mē home use device is an FDA approved device for hair removal on all skin types and body regions including the face. The device uses Elōs technology 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. Elōs technology has been used at the clinic for non-ablative skin rejuvenation. The levels of Elōs energy used with the professional devices at the clinic is much higher than the level of energy used by the mē device for home use. The current study was designed to evaluate the safety and efficacy of the mē device for home-use non-ablative skin rejuvenation. Healthy female volunteers, seeking facial skin rejuvenation treatment will be enrolled.
The study includes up to 7 visits at the clinic. The defined areas for treatment are one or more facial sub areas (e.g., forehead, peri-orbital, cheeks, peri oral). Subjects will be provided with the device and will be instructed as to the method of usage. The subjects will perform treatments at the clinic and at home according to the schedule detailed in the intervention section. Follow ups will take place at the 1 and 2 months visits. Optional additional follow up visits will take place 3 and 6 months after the initial treatment. Evaluations will include skin safety, tolerability of the procedure, improvement assessment by the study doctor and subject, satisfaction. Optionally, before/after pictures of follow-up visits vs baseline will be sent to blinded evaluators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mē device | Experimental | Device: mēThe subjects will perform treatments with the mē device at the clinic under the supervision of the study personnel at the baseline visit, 1 week and 2 week visits, and 1 month and 2 month visits. In addition the subject will be expected to perform treatments at home according to the following schedule: daily treatments at home for 5 days a week during the first month, followed by 2 treatments a week during the 2nd month, and optionally 1 time a week during the 3rd month. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy female between the ages of 25 and 60.
- Willing to sign Informed consent form and photo release form.
- Having visible lines and wrinkles in the peri-orbital and peri-oral region of the face (Fitzpatrick elastosis degree 3-6).
- Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
- Agree to make no changes in their existing skincare regime, other than use of the study products, during the study period.
Key exclusion criteria (15 listed)
- Subjects who currently use or have used in the prior 30 days any skin products that contain alpha hydroxy acids (AHA) e.g. glycolic, lactic, citric, or mandelic acid containing products or retinol/tretinoin containing products or exfoliating washes, masks or scrubs or other micro-dermabrasion skin care products on the treatment areas.
- Subjects who are unwilling to maintain their daily skin care regimen for the duration of the study.
- Subjects who have any skin pathology or condition that could interfere with the evaluation i.e. personal or family history of skin cancer, rosacea and/or requires the use of interfering topical or systemic therapies.
- Subjects with synthetic or metal implants or permanent cosmetic tattoos in the test areas.
- Subjects who have a history of abnormal scarring, e.g. keloids or have significant scarring in the areas to be treated.
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 |
|---|---|---|
| mēThe mē device will be used for self administered facial treatments that will be repeated up to 3 times every session. The duration of a treatment session is 5-10 minutes. | Device | mē device |
Primary outcome
Improvement in treated area appearance compared to baseline scored by the physician
Time frame: 1 month
Improvement will be scored by the physician using the Fitzpatrick classification of skin elastosis (FES) and the global esthetic improvement (GAI) scale in 6 categories including 1) fine lines/ wrinkles; 2) brightness; 3) tightness; 4) texture; 5) pigment; 6) overall improvement using a 5-point Likert scale where 0 represents no change and 4 represents significantly marked improvement
1 secondary outcome
Improvement in treated area appearance compared to baseline scored by the subject
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- 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 mē in people with Skin Aging and Skin Rejuvenation, 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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 3 Mar 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noa Makhervax (+972-52-8874799, noa.clinict@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in treated area appearance compared to baseline scored by the physician (time frame: 1 month). 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 3 Mar 2017.