Effect of a Transcutaneous Electrical Nerve Stimulation (TENS) Device on Overall Facial Appearance
Condition: Ageing
MeSH terms: Facies
Intervention: BMR Face
Intervention description: BMR Face used in accordance with manufacturer IFU
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 35 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy females

Summary:

      Safety and clinical performance of the BMR Face device (manufactured by Bio-Medical Research)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are able to give voluntary, written informed consent to participate in
             this study and from whom consent has been obtained including HIPAA authorization

          -  Subjects who are healthy females between 35 and 55 years of age

          -  Subjects with a Body Mass Index (BMI) between 15-35 kg/m2 (light underweighted to
             light obese)

          -  Subjects may have all skin types

          -  Subjects with age related skin laxity in the treatment area

          -  Subjects who agree not to have any procedures affecting facial volume (any fillers or
             fat transfer) for the duration of the study

          -  Subjects who agree not to have any other procedures affecting skin quality
             (microdermabrasion, resurfacing, peels, lasers, acne treatments, etc.) for the
             duration of the study

          -  Subjects who agree to make no changes in their existing skincare regime during the
             study period

          -  Subjects who agree to avoid excessive sun radiation or use appropriate sun protection
             with SPF 30 or higher

          -  Subjects who agree not to alter their diet for the duration of the study

          -  Subjects who understand this study and are able to follow study instructions and are
             willing to attend the required study visits

          -  Subjects who agree to be photographed for the purposes of the study and give consent
             for these photographs to be used in marketing advertisements where their identity will
             not be concealed in these photographs

        Exclusion Criteria:

          -  Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine
             pregnancy test will be done to rule out pregnancy.

          -  Subjects of child-bearing potential who are not using an approved method of birth
             control (oral contraceptives, IUD, contraceptive implant, barrier methods with
             spermicide or abstinence)

          -  Subjects who cannot understand or are not willing to comply with the requirements of
             the study

          -  Subjects who have any dermatologic conditions including acne, rosacea, eczema,
             psoriasis, severe sun damage or scars within the treatment area

          -  Subjects who have any known cancer including skin cancers (Basal Cell Carcinoma,
             Squamous Cell Carcinoma and Melanoma)

          -  Subjects with a history of heart disease or stroke

          -  Subjects who have any active implanted medical devices (pacemaker, pump etc)

          -  Subjects having any metal implants. Dental implants and fillings are allowed as well
             as piercings as long as they are not in the treatment area.

          -  Subjects who have used a tanning bed in the past four weeks or plan to use a tanning
             bed for the duration of the study

          -  Subjects who are HIV positive

          -  Subjects who have had systemic corticosteroid therapy in the past 6 months

          -  Subjects who have had a facial dermabrasion, chemical peel, laser, or IPL treatment in
             the past 6 months

          -  Subjects who have used botulinum toxin, hyaluronic acid, collagen, fat injections and
             /or other methods of skin augmentation (enhancement with injected or implanted
             material) in the past 6 months

          -  Subjects who have had ablative resurfacing procedure, brow lift, blepharoplasty or
             face lift in treated area in the past 12 months

          -  Subjects who have had any other surgery in treated area in the past 12 months

          -  Subjects who have an existing medical condition that the Investigator considers may
             put the subject at risk or compromise their participation in the study

          -  Subjects who have participated in another research study in the past 30 days

          -  Subjects who are currently involved in any injury litigation claims

          -  Subjects who have used the BMR Face device previously