Text Size

Laser Resurfacing Versus Dermabrasion for Scar Revision

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Minnesota - Clinical and Translational Science Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01176448
First received: June 21, 2010
Last updated: August 4, 2010
Last verified: August 2010
History of Changes
  Purpose

Dermabrasion has been the historical standard used for resurfacing scars on the skin. Recently, fractionated laser therapy has been FDA approved for scar resurfacing. This study intends to compare dermabrasion versus fractionated laser therapy for scar resurfacing.


Condition Intervention
Cicatrix
Dermabrasion
Coagulation, Laser
 Device: Fractionated laser
Device: Dermabrasion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison Evaluation of Fractional Laser Therapy and Dermabrasion for Scar Revision

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

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

Primary Outcome Measures:
  • Visual Analog Scale of scar erythema, width, and texture. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Dermabrasion is the gold standard for scar resurfacing. This study aims to assess the efficacy of fractionated laser therapy in comparison to dermabrasion. A Visual Analog Scale of Scar outcomes will be used to assess the pre-treatment scar to the post treatment scar. Assessors will be blinded to the procedure used.


Estimated Enrollment: 16
Study Start Date: April 2010
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fractionated laser
This Arm is the section of scar that will be treated with Fractionated Laser
 Device: Fractionated laser
Fractionated laser in the form of the Re:Pair CO2 laser manufactured by Solta Medical.
Active Comparator: Dermabrasion
Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
 Device: Dermabrasion
Diamond Fraise Dermabrasion will be performed in standard fashion down to papillary dermis.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 the 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176448

Locations
United States, Minnesota
Zel Skin and Laser
Edina, Minnesota, United States, 55424
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: John J Christophel, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: John Jared Christophel, University of Minnesota
ClinicalTrials.gov Identifier: NCT01176448     History of Changes
Other Study ID Numbers: UMN-1001M75732
Study First Received: June 21, 2010
Last Updated: August 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Cicatrix
Dermabrasion
Coagulation, Laser

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013