Study of the Effectiveness of Green Diode Laser Light on Body Shaping

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation
ClinicalTrials.gov Identifier:
NCT01292538
First received: February 8, 2011
Last updated: May 7, 2014
Last verified: May 2014
Results First Received: April 1, 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 GLS
Device: Placebo laser

  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 GLS 532nm

532nm green laser light therapy.

Erchonia GLS: 532 nm green diode low level laser light device

Placebo Laser

Sham light output with no therapeutic benefit

Placebo laser: Sham light output with no therapeutic benefit


Participant Flow:   Overall Study
    Erchonia GLS 532nm     Placebo Laser  
STARTED     35     32  
COMPLETED     35     32  
NOT COMPLETED     0     0  



  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 GLS 532nm

532nm green laser light therapy.

Erchonia GLS: 532 nm green diode low level laser light device

Placebo Laser

Sham light output with no therapeutic benefit

Placebo laser: Sham light output with no therapeutic benefit

Total Total of all reporting groups

Baseline Measures
    Erchonia GLS 532nm     Placebo Laser     Total  
Number of Participants  
[units: participants]
  35     32     67  
Age  
[units: years]
Mean ± Standard Deviation
  36.60  ± 10.05     39.03  ± 10.16     38.04  ± 10.08  
Gender  
[units: participants]
     
Female     28     25     53  
Male     7     7     14  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     29     32     61  
Unknown or Not Reported     6     0     6  



  Outcome Measures

1.  Primary:   Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs   [ Time Frame: 2 weeks ]

2.  Secondary:   Body Mass Index (BMI)   [ Time Frame: 2 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Subject Self-reported Satisfaction With Study Outcome   [ Time Frame: 2 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Body Weight (Pounds)   [ Time Frame: 2 weeks ]
Results not yet reported.   Anticipated Reporting 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: Elvira Walls
Organization: Regulatory Insight, Inc.
phone: 615-712-9743
e-mail: elvira@reginsight.com


No publications provided


Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT01292538     History of Changes
Other Study ID Numbers: EC-GREEN001
Study First Received: February 8, 2011
Results First Received: April 1, 2014
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board