AgeingPhase 4NCT01740440
Effect of a Transcutaneous Electrical Nerve Stimulation (TENS) Device on Overall Facial Appearance
A Phase 4 study testing BMR Face in people with Ageing, run by Bio-Medical Research, Ltd. at 1 site in United States.
Trial summary
Safety and clinical performance of the BMR Face device (manufactured by Bio-Medical Research) Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ageing
- What is being tested?
- BMR Face
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Apr 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Safety and clinical performance of the BMR Face device (manufactured by Bio-Medical Research)
Read the 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.
- Conditions
- Ageing
- Being tested
- BMR Face
- Keywords
- Healthy females
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMR FaceDevice
BMR Face used in accordance with manufacturer IFU
| Study group | Role | What they receive |
|---|---|---|
| BMR Face treatment | Other | BMR Face treatment used once a day for 12 weeks Receives: Device: BMR Face |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (2)
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).
Measured: 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.
Measured: 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Medical Research, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Sadick, Dr, Principal investigator, Sadick Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740440
- Sponsor's protocol ID
- SRG-BMR Face01
- Status last verified
- May 2016
- First submitted
- 21 Nov 2012
- Last updated
- 30 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Transcutaneous Electrical Nerve Stimulation (TENS) Device on Overall Facial Appearance
- ClinicalTrials.gov ID
- NCT01740440
- Acronym / sponsor ID
- SRG-BMR Face01
- Conditions
- Ageing
- Keywords
- Healthy females
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bio-Medical Research, Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Posted 24 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and clinical performance of the BMR Face device (manufactured by Bio-Medical Research)
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMR Face treatment | Other | Device: BMR FaceBMR Face treatment used once a day for 12 weeks |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMR FaceBMR Face used in accordance with manufacturer IFU | Device | BMR Face treatment |
Primary outcome
Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Using the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Compared to Baseline.
Time frame: 12 weeks
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).
2 secondary outcomes
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
Time frame: 6 weeks
To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment).
Time frame: 6 weeks, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ageing
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
RecruitingPhase 4
PLLA and CaHA-R for Aesthetic Rejuvenation
Aesthetic
RecruitingObservational study
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Healthy Volunteers, Non-Healthy/Non-Frail
Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Sadick, Dr principal investigator
Sadick Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BMR Face in people with Ageing, run by Bio-Medical Research, Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Using the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Compared to Baseline. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.