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Laser Resurfacing Versus Dermabrasion for Scar Revision

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01176448
First Posted: August 6, 2010
Last Update Posted: June 27, 2013
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
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
Intervention Model: Single Group Assignment
Masking: Single (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 ]
    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 ]

    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

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 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
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): 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

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
First Submitted: June 21, 2010
First Posted: August 6, 2010
Results First Submitted: November 9, 2011
Results First Posted: June 27, 2013
Last Update Posted: June 27, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes