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Withdrawn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
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
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
NCT ID
NCT01409863
First Posted
August 2, 2011
Last Updated
October 2, 2023
Sponsor
University of Minnesota
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Withdrawn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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