Back to resultsLaser 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
About this trial
This is an interventional treatment trial for Cicatrix focused on measuring Cicatrix, Dermabrasion, Coagulation, Laser
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
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
NCT ID
NCT01176448
First Posted
June 21, 2010
Last Updated
October 30, 2019
Sponsor
University of Minnesota
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
Learn more about this trial
Laser Resurfacing Versus Dermabrasion for Scar Revision
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