MĒ Device for At-Home Skin Rejuvenation

NCT02902718 | Unknown DMC FDA Device

• 1 other identifier: 300-16
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Skin Aging; Skin Rejuvenation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement in treated area appearance compared to baseline scored by the subject

  1 month

Other Outcomes (3)

• Percentage of participants with device related anticipated skin effects, serious adverse events, or adverse events

  up to 6 months

• Tolerability level of the procedure

  baseline, 1 and 2 weeks, 1 and 2 months

• Subject satisfaction

  2 weeks, 1 month, 2 months

Study Arms (1)

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.

Device: mē

Interventions

mē DEVICE

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.

mē device

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Iluminage Ltd.: lead

Study Sites (1)

Friedman Skin & Laser Center

Jerusalem, Israel, Israel

RECRUITING

Study Officials

• David J Friedman, MD

  Friedman Laser & Skin Center

  PRINCIPAL INVESTIGATOR

• Lilach Gavish, PhD

  HUJI

  STUDY DIRECTOR

Central Study Contacts

Noa Makhervax

CONTACT

+972-52-8874799; noa.clinict@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 16, 2016
• Study Start: February 28, 2017
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)