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Fractional Laser Therapy and Dermabrasion for Scar Revision

This study has been withdrawn prior to enrollment.
(PI has left University of Minnesota.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01409863
First Posted: August 4, 2011
Last Update Posted: January 26, 2015
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.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
The goals of this study will be to compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.

Condition Intervention
Scar Procedure: laser and standard diamond fraise dermabrasion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison Evaluation of Fractional Laser Therapy an Dermabrasion for Scar Revision

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • safety and efficacy of fractional photothermolysis [ Time Frame: Post Surgery ]
    compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.


Enrollment: 0
Study Start Date: March 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: laser and standard diamond fraise dermabrasion
laser and standard diamond fraise dermabrasion
Procedure: laser and standard diamond fraise dermabrasion
standard dermabrasion, CO2 laser resurfacing

Detailed Description:
Post traumatic and post surgical scar resurfacing is a common reason for patient visits to dermatologists and plastic surgeons. The Fraxel Laser is a new FDA cleared treatment for textural irregularities of the skin. There have been no studies examining the efficacy of Fraxel specifically for scar resurfacing though it is being used in clinical practice as its clearance was given under hte umbrella of "coagulation of soft tissue." Dermabrasion is the gold standard for scar resurfacing and provides the criterion against which Fraxel therapy should be measured.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • post surgical or post traumatic scar on face or scalp
  • age 18 or older
  • able to read and comprehend English
  • Willing to follow treatment schedule and post treatment care requirements
  • signed informed consent form
  • Fitzpatrick skin type I-III

Exclusion Criteria:

  • known photosensitivity
  • taken any medications known to induce photosensitivity in previous three months
  • taken accutane within past 12 months
  • pregnant or nursing
  • currently on topical or oral antibiotics
  • immunocompromised status
  • skin type IV or greater
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409863


Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: John Christophel, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01409863     History of Changes
Other Study ID Numbers: 1001M75732
First Submitted: August 2, 2011
First Posted: August 4, 2011
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
post surgical or post traumatic scar on face or scalp