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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740440
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : March 24, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Bio-Medical Research, Ltd.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Ageing
Intervention Device: BMR Face
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BMR Face Treatment
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BMR Face treatment used once a day for 12 weeks

BMR Face

Period Title: Overall Study
Started 30
Completed 27
Not Completed 3
Reason Not Completed
Lost to Follow-up             3
Arm/Group Title BMR Face Treatment
Hide Arm/Group Description

BMR Face treatment used once a day for 12 weeks

BMR Face

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
45  (3.7)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Female participants
Number Analyzed 30 participants
30
1.Primary Outcome
Title Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Using the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Compared to Baseline.
Hide Description

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).

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations.
Arm/Group Title BMR Face Treatment
Hide Arm/Group Description:

BMR Face treatment used once a day for 12 weeks

BMR Face

Overall Number of Participants Analyzed 23
Mean (Full Range)
Unit of Measure: Scores on a Scale
GAIS (Investigator)
2.17
(0 to 4)
GAIS (Subject)
2.26
(0 to 4)
2.Secondary Outcome
Title 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
Hide Description

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).

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations
Arm/Group Title BMR Face Treatment
Hide Arm/Group Description:

BMR Face treatment used once a day for 12 weeks

BMR Face: BMR Face used in accordance with manufacturer IFU

Overall Number of Participants Analyzed 23
Mean (Full Range)
Unit of Measure: units on a scale
GAIS (Investigator)
2.04
(0 to 4)
GAIS (Subject)
1.26
(0 to 4)
3.Secondary Outcome
Title To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment).
Hide Description 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.
Time Frame 6 weeks, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations
Arm/Group Title BMR Face Treatment
Hide Arm/Group Description:

BMR Face treatment used once a day for 12 weeks

BMR Face

Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: percentage of subjects
Week 12 - Very Satisfied 34.8
Week 12 - Satisfied 47.8
Week 12 - No opinion 4.3
Week 12 - Unsatisfied 13.0
Week 6 - Very Satisfied 17.4
Week 6 - Satisfied 39.1
Week 6 - No opinion 30.4
Week 6 - Unsatisfied 13.0
Time Frame Subject were followed for Adverse Events for the duration of their participation in the study (up to 12 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BMR Face Treatment
Hide Arm/Group Description

BMR Face treatment used once a day for 12 weeks

BMR Face

All-Cause Mortality
BMR Face Treatment
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
BMR Face Treatment
Affected / at Risk (%)
Total   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BMR Face Treatment
Affected / at Risk (%)
Total   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gary Rainsford
Organization: BioMedical Research Ltd
Phone: 0035391774361
EMail: grainsford@bmr.ie
Layout table for additonal information
Responsible Party: Bio-Medical Research, Ltd.
ClinicalTrials.gov Identifier: NCT01740440    
Other Study ID Numbers: SRG-BMR Face01
First Submitted: November 21, 2012
First Posted: December 4, 2012
Results First Submitted: July 17, 2014
Results First Posted: March 24, 2016
Last Update Posted: June 30, 2016