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Fractional Laser Therapy and Dermabrasion for Scar Revision

Primary Purpose

Scar

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laser and standard diamond fraise dermabrasion
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scar focused on measuring post surgical or post traumatic scar on face or scalp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    No Intervention

    Arm Label

    laser and standard diamond fraise dermabrasion

    Arm Description

    laser and standard diamond fraise dermabrasion

    Outcomes

    Primary Outcome Measures

    safety and efficacy of fractional photothermolysis
    compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 2, 2011
    Last Updated
    October 2, 2023
    Sponsor
    University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01409863
    Brief Title
    Fractional Laser Therapy and Dermabrasion for Scar Revision
    Official Title
    A Comparison Evaluation of Fractional Laser Therapy an Dermabrasion for Scar Revision
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI has left University of Minnesota.
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    March 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Minnesota

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Scar
    Keywords
    post surgical or post traumatic scar on face or scalp

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    laser and standard diamond fraise dermabrasion
    Arm Type
    No Intervention
    Arm Description
    laser and standard diamond fraise dermabrasion
    Intervention Type
    Procedure
    Intervention Name(s)
    laser and standard diamond fraise dermabrasion
    Intervention Description
    standard dermabrasion, CO2 laser resurfacing
    Primary Outcome Measure Information:
    Title
    safety and efficacy of fractional photothermolysis
    Description
    compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.
    Time Frame
    Post Surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Christophel, MD
    Organizational Affiliation
    University of Minnesota
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Fractional Laser Therapy and Dermabrasion for Scar Revision

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