Trial Outcomes & Findings for Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser (Flanks) (NCT NCT03756168)

NCT ID: NCT03756168

Last Updated: 2024-01-30

Results Overview

Change in the percentage of fat thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2024-01-30

Participant Flow

Participant milestones

Measure	All Subjects All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area.
Overall Study STARTED	30
Overall Study Had at Least 1 Treatment	29
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of the Safety and Efficacy of a 1060 nm Diode Laser (Flanks)

Baseline characteristics by cohort

Measure	All Subjects Treated n=29 Participants All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area.
Age, Continuous	47.2 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Fitzpatrick Skin Type I	0 Participants n=5 Participants
Fitzpatrick Skin Type II	15 Participants n=5 Participants
Fitzpatrick Skin Type III	8 Participants n=5 Participants
Fitzpatrick Skin Type IV	4 Participants n=5 Participants
Fitzpatrick Skin Type V	1 Participants n=5 Participants
Fitzpatrick Skin Type VI	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Change in the percentage of fat thickness of the adipose layer as measured by ultrasound at 12 weeks post-treatment as compared to baseline.

Outcome measures

Measure

All Subjects n=27 Participants All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks. Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area.

Change in the Percentage of Fat Thickness From Baseline to 12-weeks Post-treatment

-6.9 percentage of body fat Standard Error 1.4

SECONDARY outcome

Timeframe: Week 12

Change in the abdominal circumference at 12 weeks post-treatment as compared to baseline

Outcome measures

Measure

All Subjects n=27 Participants All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks. Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area.

Change in Abdominal Circumference From Baseline to 12 Weeks Post-treatment

-0.87 centimeters Standard Error 0.55

SECONDARY outcome

Timeframe: Week 12

Subject satisfaction with treatment at 12 weeks was assessed using the 5-point Likert subject satisfaction scale. 5 is very satisfied, while 1 is very unsatisfied

Outcome measures

Measure

All Subjects n=27 Participants All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks. Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area.

Subject Satisfaction

3.3 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Day 1

Treatment pain assessed immediately post-treatment as measured using the Wong-Baker Faces Scale. Pain was measured on a scale from 0-10 (10 worst pain ever, to 0 no pain at all)

Outcome measures

Measure

All Subjects n=29 Participants All subjects received a single treatment with Venus Bliss' 1064 nm laser administered to the flanks. Venus Bliss is a non-invasive medical aesthetic device designed for body contouring. The device contains four 1060 nm diode laser applicators which are 60x60 mm in size. It has a separate RF/PEMF applicator, but this was not used in this study. There is a belt included with the system to allow for the secure attachment of the applicators to the treatment area.

Treatment Pain

3.1 score on a scale Standard Deviation 2.0

Adverse Events

All Subjects

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

Director of Clinical Affairs

Venus Concept

Phone: 888-907-0115

Email: mgronski@venusconcept.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place