Trial Outcomes & Findings for Study of Low Level Laser Therapy for Body Contouring (NCT NCT00738426)

NCT ID: NCT00738426

Last Updated: 2020-02-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2020-02-10

Participant Flow

Participant milestones

Measure	Erchonia ML Scanner (MLS) red diode low level laser light energy Erchonia ML Scanner (MLS): Red diode low level laser light energy.	Sham Device non-therapeutic sham light output Sham device: non-therapeutic light energy output
Overall Study STARTED	37	35
Overall Study COMPLETED	35	32
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Low Level Laser Therapy for Body Contouring

Baseline characteristics by cohort

Measure	Erchonia ML Scanner (MLS) n=35 Participants Red diode low level laser light energy Erchonia ML Scanner (MLS): Red diode low level laser light energy.	Sham Device n=32 Participants non-therapeutic sham light output Sham device: non-therapeutic light energy output	Total n=67 Participants Total of all reporting groups
Sex: Female, Male Female	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	32 participants n=7 Participants	67 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Measure	Erchonia ML Scanner (MLS) n=35 Participants Red diode low level laser light energy Erchonia ML Scanner (MLS): Red diode low level laser light energy.	Sham Device n=32 Participants non-therapeutic sham light output Sham device: non-therapeutic light energy output
Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.	21 participants	2 participants

Adverse Events

Erchonia ML Scanner (MLS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Device

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

Dr. Robert F. Jackson

Cosmetic Surgery

Phone: 765-662-8303

Email: rjlipodr@comteck.com

Results disclosure agreements

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