Trial Outcomes & Findings for LED Device for Non-Invasive Lipolysis (NCT NCT03171051)

Last Updated: 2020-11-09

Results Overview

Immediately (within 2 minutes) after treatment of the area, 3 sterile thermocouple needles of different lengths (9.5-14 mm), will be inserted into the center of each applicator footprint. Temperature readings from each thermocouple needle will be recorded.

Recruitment status

TERMINATED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

At time of treatment

Results posted on

2020-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	Lipolysis Treatment The right flank of the abdomen will be treated with the LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. 950 nm LED Device: Device to be used in aesthetic and cosmetic procedures which consists of a console and an applicator belt that delivers the treatment LED to the subject's skin. The left flank of the abdomen will be treated with the diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. 1050nm Diode Laser Device: FDA approved laser device that has been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LED Device for Non-Invasive Lipolysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lipolysis Treatment n=10 abdomen The right flank of the abdomen will be treated with the LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. No baseline temperatures were obtained. The left flank of the abdomen will be treated with the diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. No baseline temperatures were obtained.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	0 Participants n=5 Participants
Race (NIH/OMB) White	8 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
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of treatment

Population: Subject had one side of their abdomen treated with the experimental 950nm LED and the other side of their abdomen treated with the 1050nm diode laser. Note that temperature data was not available for 1 participant for the 1050nm laser at the 9.5mm tissue depth.

Outcome measures

Outcome measures
Measure	Lipolysis Treatment n=10 Participants The right flank of the abdomen will be treated with the LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. 950 nm LED Device: Device to be used in aesthetic and cosmetic procedures which consists of a console and an applicator belt that delivers the treatment LED to the subject's skin. The left flank of the abdomen will be treated with the diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. 1050nm Diode Laser Device: FDA approved laser device that has been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body.
Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths 950nm LED Mean Temperature at 14mm	44.9 degrees Celsius Standard Deviation 2.3
Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths 1050nm Laser Temperature at 14mm	42.5 degrees Celsius Standard Deviation 2.6
Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths 950nm LED Mean Temperature at 9.5mm	43.9 degrees Celsius Standard Deviation 2.7
Temperature Profile Comparison of the LED Device as Compare to the Reference Device (Diode Laser) at Various Tissue Depths 1050nm Laser Mean Temperature at 9.5mm	41.5 degrees Celsius Standard Deviation 3.8

SECONDARY outcome

Timeframe: Time of treatment

Subjects reported level of discomfort and pain after treatment with LED and Laser applicators on a 10 cm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 'no pain at all' (value of 0 cm) and 'worst pain imaginable' (value of 10 cm).

Outcome measures

Outcome measures
Measure	Lipolysis Treatment n=10 Participants The right flank of the abdomen will be treated with the LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. 950 nm LED Device: Device to be used in aesthetic and cosmetic procedures which consists of a console and an applicator belt that delivers the treatment LED to the subject's skin. The left flank of the abdomen will be treated with the diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. 1050nm Diode Laser Device: FDA approved laser device that has been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body.
Visual Analog Scale (VAS) 950nm LED VAS	4.1 score on a scale Interval 0.4 to 7.6
Visual Analog Scale (VAS) 1050nm Laser VAS	3.48 score on a scale Interval 0.3 to 7.7

Adverse Events

Lipolysis Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lipolysis Treatment n=10 participants at risk The right flank of the abdomen will be treated with the 950nm LED device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. The left flank of the abdomen will be treated with the 1050nm diode laser device. The treatment area will be heated initially for 4 minutes at 41W followed by a duty cycle of 25 sec on and 10 sec off time at 29W for 16 minutes. Total treatment time will be 24 minutes. 950 nm LED Device: Device to be used in aesthetic and cosmetic procedures which consists of a console and an applicator belt that delivers the treatment LED to the subject's skin. 1050nm Diode Laser Device: FDA approved laser device that has been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body.
Skin and subcutaneous tissue disorders inflammatory panniculitis	10.0% 1/10 • Number of events 1 • The adverse events were collected from 7 June 2017 until 13 July 2017. All reportable events with start dates occurring any time after informed consent is obtained were followed until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.

Additional Information

Yoni Iger

Venus Concept Ltd

Phone: 888-907-0115

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place