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Laser Resurfacing Versus Dermabrasion for Scar Revision

Primary Purpose

Cicatrix, Dermabrasion, Coagulation, Laser

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fractionated laser
Dermabrasion
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix focused on measuring Cicatrix, Dermabrasion, Coagulation, Laser

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 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

Sites / Locations

  • Zel Skin and Laser

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fractionated laser

Dermabrasion

Arm Description

This Arm is the section of scar that will be treated with Fractionated Laser

Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.

Outcomes

Primary Outcome Measures

Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing
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.
Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement : 1-25% improvement : 26-50% improvement : 51-75% improvement : 76-100% improvement

Full Information

First Posted
June 21, 2010
Last Updated
October 30, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01176448
Brief Title
Laser Resurfacing Versus Dermabrasion for Scar Revision
Official Title
A Comparison Evaluation of Fractional Laser Therapy and Dermabrasion for Scar Revision
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix, Dermabrasion, Coagulation, Laser
Keywords
Cicatrix, Dermabrasion, Coagulation, Laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractionated laser
Arm Type
Experimental
Arm Description
This Arm is the section of scar that will be treated with Fractionated Laser
Arm Title
Dermabrasion
Arm Type
Active Comparator
Arm Description
Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
Intervention Type
Device
Intervention Name(s)
Fractionated laser
Intervention Description
Fractionated laser in the form of the Re:Pair CO2 laser manufactured by Solta Medical.
Intervention Type
Device
Intervention Name(s)
Dermabrasion
Intervention Description
Diamond Fraise Dermabrasion will be performed in standard fashion down to papillary dermis.
Primary Outcome Measure Information:
Title
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing
Description
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.
Time Frame
Day 0, Week1, Month 1
Secondary Outcome Measure Information:
Title
Visual Analog Scale for Assessing Scar Improvement.
Description
Visual Analog Scale for assessing scar improvement. 0 : Worsening or no improvement : 1-25% improvement : 26-50% improvement : 51-75% improvement : 76-100% improvement
Time Frame
3 months

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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Christophel, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zel Skin and Laser
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55424
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22268699
Citation
Jared Christophel J, Elm C, Endrizzi BT, Hilger PA, Zelickson B. A randomized controlled trial of fractional laser therapy and dermabrasion for scar resurfacing. Dermatol Surg. 2012 Apr;38(4):595-602. doi: 10.1111/j.1524-4725.2011.02283.x. Epub 2012 Jan 23.
Results Reference
derived

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Laser Resurfacing Versus Dermabrasion for Scar Revision

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