Laser Resurfacing Versus Dermabrasion for Scar Revision

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01176448
First received: June 21, 2010
Last updated: June 25, 2013
Last verified: June 2013
  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:


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

Primary Outcome Measures:
  • Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing [ Time Frame: Day 0, Week1, Month 1 ] [ Designated as safety issue: Yes ]
    Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe.


Secondary Outcome Measures:
  • Visual Analog Scale for Assessing Scar Improvement. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement

    1. : 1-25% improvement
    2. : 26-50% improvement
    3. : 51-75% improvement
    4. : 76-100% improvement


Enrollment: 6
Study Start Date: April 2010
Study Completion Date: September 2010
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
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: 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 by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01176448     History of Changes
Other Study ID Numbers: UMN-1001M75732
Study First Received: June 21, 2010
Results First Received: November 9, 2011
Last Updated: June 25, 2013
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 September 16, 2014