Effect of a Transcutaneous Electrical Nerve Stimulation (TENS) Device on Overall Facial Appearance

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

Study Overview

• Status: Completed
• Conditions: Ageing
• Intervention / Treatment: Device: BMR Face

Detailed Description

Evaluate the efficacy of the BMR Face device in relation to facial appearance at 12 weeks compared to baseline. Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).

The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement

Secondary objectives are to evaluate safety and further evaluate the subject's and investigator's satisfaction (both a live and blinded assessor) with the BMR Face treatment.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New York, New Jersey, United States, 10075
      • Sadick Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: BMR Face treatment; BMR Face treatment used once a day for 12 weeks	Device: BMR Face; BMR Face used in accordance with manufacturer IFU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Using the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Compared to Baseline.	Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Including the Global Aesthetic Improvement Scale (GAIS) at 6 Weeks Compared to Baseline	Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS). The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4).	6 weeks
To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment).	The Subject Satisfaction Assessment Scale is a 5 point scale where a subject rates their satisfaction level as Very Satisfied, Satisfied, No Opinion, Unsatisfied or Very Unsatisfied.	6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Bio-Medical Research, Ltd.
• Investigators: Principal Investigator: Neil Sadick, Dr, Sadick Research Group

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: November 21, 2012
• First Submitted That Met QC Criteria: November 30, 2012
• First Posted (Estimate): December 4, 2012

Study Record Updates

• Last Update Posted (Estimate): June 30, 2016
• Last Update Submitted That Met QC Criteria: May 30, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Healthy females
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: SRG-BMR Face01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No