Study of the Use of Low Level Laser Therapy to Reduce Acne

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation
ClinicalTrials.gov Identifier:
NCT01276535
First received: January 11, 2011
Last updated: November 7, 2015
Last verified: November 2015
Results First Received: April 12, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acne
Intervention: Device: Erchonia MLS + Erchonia THL

  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
12 subjects were recruited and enrolled from March 2, 2010 through April 29, 2010 at one medical clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no significant events or approaches for the overall study following participant enrollment, but prior to group assignment. There were no enrolled participants excluded from the trial before assignment to groups.

Reporting Groups
  Description
Erchonia MLS & Erchonia THL

The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.

The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject.


Participant Flow:   Overall Study
    Erchonia MLS & Erchonia THL  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     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 MLS & Erchonia THL

The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.

The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject.


Baseline Measures
    Erchonia MLS & Erchonia THL  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean (Standard Deviation)
  29.5  (5.98)  
Gender  
[units: participants]
 
Female     7  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Grade on the Burton et al. Acne Severity Grade Scale   [ Time Frame: baseline and 6 weeks ]

2.  Secondary:   Change From Baseline in Inflammatory Lesion Count at 6 Weeks   [ Time Frame: Baseline and 6 weeks ]

3.  Secondary:   Change From Baseline in Non-Inflammatory Lesion Count at 6 Weeks   [ Time Frame: Baseline and 6 weeks ]


  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: Gregory A. Nikolaidis, MD
Organization: Westlake Dermatology
phone: 512-328-3376
e-mail: karen@westlakedermatology.com


No publications provided


Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT01276535     History of Changes
Other Study ID Numbers: ECACNEP1
Study First Received: January 11, 2011
Results First Received: April 12, 2013
Last Updated: November 7, 2015
Health Authority: United States: Institutional Review Board