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Study of Low Level Laser Therapy for Body Contouring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00738426
Recruitment Status : Completed
First Posted : August 20, 2008
Results First Posted : May 2, 2014
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Body Contouring
Interventions Device: Erchonia ML Scanner (MLS)
Device: Sham device
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erchonia ML Scanner (MLS) Sham Device
Hide Arm/Group Description

red diode low level laser light energy

Erchonia ML Scanner (MLS): Red diode low level laser light energy.

non-therapeutic sham light output

Sham device: non-therapeutic light energy output

Period Title: Overall Study
Started 37 35
Completed 35 32
Not Completed 2 3
Arm/Group Title Erchonia ML Scanner (MLS) Sham Device Total
Hide Arm/Group Description

Red diode low level laser light energy

Erchonia ML Scanner (MLS): Red diode low level laser light energy.

non-therapeutic sham light output

Sham device: non-therapeutic light energy output

Total of all reporting groups
Overall Number of Baseline Participants 35 32 67
Hide Baseline Analysis Population Description
[Not Specified]
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 32 participants 67 participants
Female
33
  94.3%
31
  96.9%
64
  95.5%
Male
2
   5.7%
1
   3.1%
3
   4.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 32 participants 67 participants
Hispanic or Latino
1
   2.9%
0
   0.0%
1
   1.5%
Not Hispanic or Latino
34
  97.1%
32
 100.0%
66
  98.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 32 participants 67 participants
35 32 67
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 32 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
 100.0%
32
 100.0%
67
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.
Hide Description [Not Specified]
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Erchonia ML Scanner (MLS) Sham Device
Hide Arm/Group Description:

Red diode low level laser light energy

Erchonia ML Scanner (MLS): Red diode low level laser light energy.

non-therapeutic sham light output

Sham device: non-therapeutic light energy output

Overall Number of Participants Analyzed 35 32
Measure Type: Number
Unit of Measure: participants
21 2
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erchonia ML Scanner (MLS) Sham Device
Hide Arm/Group Description

red diode low level laser light energy

Erchonia ML Scanner (MLS): Red diode low level laser light energy.

non-therapeutic sham light output

Sham device: non-therapeutic light energy output

All-Cause Mortality
Erchonia ML Scanner (MLS) Sham Device
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Erchonia ML Scanner (MLS) Sham Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/32 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erchonia ML Scanner (MLS) Sham Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/32 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert F. Jackson
Organization: Cosmetic Surgery
Phone: 765-662-8303
EMail: rjlipodr@comteck.com
Layout table for additonal information
Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT00738426    
Other Study ID Numbers: BCL-001
First Submitted: August 18, 2008
First Posted: August 20, 2008
Results First Submitted: February 25, 2014
Results First Posted: May 2, 2014
Last Update Posted: February 10, 2020