Fractional Laser Therapy and Dermabrasion for Scar Revision

This study has been withdrawn prior to enrollment.
(PI has left University of Minnesota.)
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01409863
First received: August 2, 2011
Last updated: January 21, 2015
Last verified: January 2015
  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: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 2, 2011
Last Updated: January 21, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 25, 2016