Study of Low Level Laser Therapy for Body Contouring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation
ClinicalTrials.gov Identifier:
NCT00738426
First received: August 18, 2008
Last updated: April 1, 2014
Last verified: April 2014
Results First Received: February 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Body Contouring
Interventions: Device: Erchonia ML Scanner (MLS)
Device: Sham device

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Erchonia ML Scanner (MLS)     Sham Device  
STARTED     37     35  
COMPLETED     35     32  
NOT COMPLETED     2     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Erchonia ML Scanner (MLS)     Sham Device     Total  
Number of Participants  
[units: participants]
  35     32     67  
Gender  
[units: participants]
     
Female     33     31     64  
Male     2     1     3  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     0     1  
Not Hispanic or Latino     34     32     66  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     35     32     67  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     35     32     67  
>=65 years     0     0     0  



  Outcome Measures

1.  Primary:   Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.   [ Time Frame: 2 weeks ]

2.  Secondary:   Changes in Weight, Body Mass Index (BMI) and Scores on the Body Shape Questionnaire (BSQ).   [ Time Frame: 4 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Dr. Robert F. Jackson
Organization: Cosmetic Surgery
phone: 765-662-8303
e-mail: rjlipodr@comteck.com


No publications provided


Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT00738426     History of Changes
Other Study ID Numbers: BCL-001
Study First Received: August 18, 2008
Results First Received: February 25, 2014
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board