MĒ Device for At-Home Skin Rejuvenation

Skin Aging Clinical Trial

— SR3-Me  

Official title:

Evaluation of the Safety and Efficacy of the Mē Device for At-Home Skin Rejuvenation Treatment - A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02902718
• Other study ID #: 300-16
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2016
• Last updated: February 28, 2017
• Start date: February 28, 2017
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: Iluminage Ltd.
• Contact: Noa Makhervax
• Phone: +972-52-8874799
• Email: noa.clinict[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to evaluate the feasibility of the Mē device for at home facial skin rejuvenation.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Healthy female between the ages of 25 and 60.

2. Willing to sign Informed consent form and photo release form.

3. Having visible lines and wrinkles in the peri-orbital and peri-oral region of the face (Fitzpatrick elastosis degree 3-6).

4. Able and willing to comply with all visit, treatment and evaluation schedules and requirements.

5. Agree to make no changes in their existing skincare regime, other than use of the study products, during the study period.

6. 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).

Exclusion Criteria:

1. 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.

2. Subjects who are unwilling to maintain their daily skin care regimen for the duration of the study.

3. 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.

4. Subjects with synthetic or metal implants or permanent cosmetic tattoos in the test areas.

5. Subjects who have a history of abnormal scarring, e.g. keloids or have significant scarring in the areas to be treated.

6. Subjects with bleeding disorders or taking anticoagulation medications, including heavy use of aspirin.

7. 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.

8. 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.

9. Subjects who have a history of light triggered seizures.

10. 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.

11. Subject's use of oral isotretinoin (Accutane®) within 12 months of initial device application or during the course of the study.

12. Subjects having had facial skin treatments with any professional laser, light based, radiofrequency or other devices within the last year.

13. Subjects ever having facial skin treatments with home use laser, light based or radiofrequency or other devices, i.e. PaloVia® or Tria®.

14. 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.

15. Subjects who have had sun exposure or used a tanning bed 4 weeks prior to the start of the study.

Related Conditions & MeSH terms

• Skin Aging
• Skin Rejuvenation

Intervention

Device:
• me
The me 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.

Locations

Country	Name	City	State
Israel	Friedman Skin & Laser Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Iluminage Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 will be evaluated on site by a dermatologist. This will include the following clinical outcomes: Presence of prolonged erythema; Presence of prolonged edema; Blister formation; Ulcer formation; Pigment changes (hypo/hyper); Textural changes; Scarring; Infection; Pruritis; Allergic reaction	up to 6 months
Other	Tolerability level of the procedure	Subject self report of the tolerability of the procedure using a visual analog scale (VAS) immediately at the end of each treatment session at the clinic.	baseline, 1 and 2 weeks, 1 and 2 months
Other	Subject satisfaction	Subject's overall satisfaction will be scored by the subject at follow up visits according to the satisfaction assessment scale based on a 5-point where 0 represents not satisfied and 4 represents extremely satisfied.	2 weeks, 1 month, 2 months
Primary	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	1 month
Secondary	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; 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 month