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Fractional Resurfacing Device for Treatment of Acne Scarring

This study has been completed.
Sponsor:
Collaborators:
Reliant Technologies, Inc. Mountain View, CA
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Christopher Zachary, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00585286
First received: December 26, 2007
Last updated: December 13, 2013
Last verified: December 2013
Results First Received: June 17, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acne
Scar
Intervention: Device: 10,600 nm fractional carbon dioxide laser system

  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
30 total patients with moderate to severe acne scarring were recruited from 3/2007-5/2008 between two locations. Of these, 15 patients received treatment and 14 patients completed the full course of the study at the University of California, Irvine General Clinical Research Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects must not have been treated with other lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 12 months of enrollment.

Reporting Groups
  Description
Fractional Carbon Dioxide Laser System Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional carbon dioxide laser system.

Participant Flow:   Overall Study
    Fractional Carbon Dioxide Laser System  
STARTED     15  
COMPLETED     14  
NOT COMPLETED     1  
Lost to Follow-up                 1  



  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.
Of 30 patients enrolled between two research centers, 15 subjects were enrolled at the UC Irvine General Clinical Research Center

Reporting Groups
  Description
Fractional CO2 Laser System Thirty healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.

Baseline Measures
    Fractional CO2 Laser System  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  36  ± 13  
Gender  
[units: participants]
 
Female     9  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Improvement of Acne Scarring   [ Time Frame: Baseline, 1 month and 3 months post-treatment ]

2.  Primary:   Average Improvement in Surface Texture   [ Time Frame: Baseline, 1 month and 3 months post-treatment ]

3.  Primary:   Degree of Atrophy   [ Time Frame: Baseline, 1 month and 3 months post-treatment ]

4.  Secondary:   Pain Tolerance   [ Time Frame: At treatment visit (up to 3 visits) ]


  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
There were no major limitations to this trial. The trial was completed without any technical problems or major complications.


  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: Christopher Zachary, FRCP, MBBS/Prinicipal Investigator
Organization: University of California, Irvine
phone: (949) 824-7103
e-mail: czachary@uci.edu


No publications provided


Responsible Party: Christopher Zachary, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585286     History of Changes
Other Study ID Numbers: 2006-5328
Study First Received: December 26, 2007
Results First Received: June 17, 2011
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration