Laser Resurfacing Versus Dermabrasion for Scar Revision

October 30, 2019 updated by: University of Minnesota

A Comparison Evaluation of Fractional Laser Therapy and Dermabrasion for Scar Revision

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Edina, Minnesota, United States, 55424
        • Zel Skin and Laser

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0, Week1, Month 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: John J Christophel, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

June 21, 2010

First Submitted That Met QC Criteria

August 4, 2010

First Posted (ESTIMATE)

August 6, 2010

Study Record Updates

Last Update Posted (ACTUAL)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1001M75732-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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