Trial Outcomes & Findings for Effect of a Transcutaneous Electrical Nerve Stimulation (TENS) Device on Overall Facial Appearance (NCT NCT01740440)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

12 weeks

Results posted on

2016-06-30

Participant Flow

Participant milestones

Participant milestones
Measure	BMR Face Treatment BMR Face treatment used once a day for 12 weeks BMR Face
Overall Study STARTED	30
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	BMR Face Treatment BMR Face treatment used once a day for 12 weeks BMR Face
Overall Study Lost to Follow-up	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BMR Face Treatment n=30 Participants BMR Face treatment used once a day for 12 weeks BMR Face
Age, Continuous	45 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex/Gender, Customized	30 female participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 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.

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).

Outcome measures

Outcome measures
Measure	BMR Face Treatment n=23 Participants BMR Face treatment used once a day for 12 weeks BMR Face
Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Using the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Compared to Baseline. GAIS (Investigator)	2.17 Scores on a Scale Interval 0.0 to 4.0
Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Using the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Compared to Baseline. GAIS (Subject)	2.26 Scores on a Scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 6 weeks

Population: 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

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).

Outcome measures

Outcome measures
Measure	BMR Face Treatment n=23 Participants BMR Face treatment used once a day for 12 weeks BMR Face
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 GAIS (Investigator)	2.04 units on a scale Interval 0.0 to 4.0
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 GAIS (Subject)	1.26 units on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 6 weeks, 12 weeks

Population: 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

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.

Outcome measures

Outcome measures
Measure	BMR Face Treatment n=23 Participants BMR Face treatment used once a day for 12 weeks BMR Face
To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment). Week 12 - Very Satisfied	34.8 percentage of subjects
To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment). Week 12 - Satisfied	47.8 percentage of subjects
To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment). Week 12 - No opinion	4.3 percentage of subjects
To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment). Week 12 - Unsatisfied	13.0 percentage of subjects
To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment). Week 6 - Very Satisfied	17.4 percentage of subjects
To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment). Week 6 - Satisfied	39.1 percentage of subjects
To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment). Week 6 - No opinion	30.4 percentage of subjects
To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment). Week 6 - Unsatisfied	13.0 percentage of subjects

Adverse Events

BMR Face Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gary Rainsford

BioMedical Research Ltd

Phone: 0035391774361

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER