Fractional Laser Therapy and Dermabrasion for Scar Revision

October 2, 2023 updated by: University of Minnesota

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

The goals of this study will be to compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

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

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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: laser and standard diamond fraise dermabrasion
Procedure: laser and standard diamond fraise dermabrasion
standard dermabrasion, CO2 laser resurfacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety and efficacy of fractional photothermolysis
Time Frame: Post Surgery
compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.
Post Surgery

Collaborators and Investigators

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

Sponsor

University of Minnesota

Investigators

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

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

March 1, 2010

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

August 2, 2011

First Submitted That Met QC Criteria

August 3, 2011

First Posted (Estimated)

August 4, 2011

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1001M75732

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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