NCT02902718

MĒ Device for At-Home Skin Rejuvenation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Iluminage Ltd. · Industry
• Sex: Female
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Skin Aging
• Skin Rejuvenation

Interventions

Type	Name	Description
DEVICE	mē	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.

Timeline

• Start date: 2017-02-28
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2016-09-16
• Last updated: 2017-03-03

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study