Trial Outcomes & Findings for Clinical Evaluation of the Safety and Efficacy of a 1060nm Diode Laser (Abdomen) (NCT NCT03756350)

NCT ID: NCT03756350

Last Updated: 2023-07-03

Results Overview

Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Week 12 vs baseline
• Results posted on: 2023-07-03

Participant Flow

Participant milestones

Measure	Treatment Subjects Single group of subjects which will have the treatment of a 1060nm diode laser administered to them. 1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Treatment Subjects Single group of subjects which will have the treatment of a 1060nm diode laser administered to them. 1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

Overall Study Lost to Follow-up

1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment Subjects n=29 Participants Single group of subjects which will have the treatment of a 1060nm diode laser administered to them. 1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.
Age, Continuous	45 years n=93 Participants
Sex: Female, Male Female	26 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	22 Participants n=93 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: Week 12 vs baseline

Population: All subjects who had baseline and Week 12 follow up photos.

Photographic evaluation by independent blinded evaluators with correct identification of pre-treatment baseline images when compared to post-treatment images taken at 12 weeks

Outcome measures

Measure

Treatment Subjects n=81 Photo sets Single group of subjects which will have the treatment of a 1060nm diode laser administered to them. 1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

Number of Before and After Photograph Sets Correctly Identified by Independent, Blinded Evaluators

54 Photo sets

SECONDARY outcome

Timeframe: week 12

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

Outcome measures

Measure

Treatment Subjects n=29 Participants Single group of subjects which will have the treatment of a 1060nm diode laser administered to them. 1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

Change in Fat Thickness

-9.8 Percent change in abdominal fat Standard Error 1.56

SECONDARY outcome

Timeframe: Week 12

Subject satisfaction with treatment at 12 weeks after treatment using the 5-point Likert Subject Satisfaction Scale. A score of 4 is very satisfied and 0 is very unsatisfied.

Outcome measures

Measure

Treatment Subjects n=29 Participants Single group of subjects which will have the treatment of a 1060nm diode laser administered to them. 1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

Subject Satisfaction

2.9 score on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: Week 1

Subject assessment of discomfort and pain post treatment as measured using the Wong Baker Faces Scale, which is a 10 point scale with 10 being the worst pain ever and 0 being no pain.

Outcome measures

Measure

Treatment Subjects n=29 Participants Single group of subjects which will have the treatment of a 1060nm diode laser administered to them. 1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

Treatment Pain

2.6 score on a scale Standard Deviation 1.6

Adverse Events

Treatment Subjects

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Treatment Subjects n=30 participants at risk Single group of subjects which will have the treatment of a 1060nm diode laser administered to them. 1060nm diode laser: Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.

Skin and subcutaneous tissue disorders Not visible, but palpable nodules

6.7% 2/30 • 12 weeks following treatment

Additional Information

Dr. Matthew Gronski

Venus Concept

Phone: (888) 907-0115

Email: mgronski@venusconcept.com

Results disclosure agreements

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