Skin Aging Clinical Trial
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.
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.
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