Back to resultsTreatment of Surgical Scars Using the Pulsed Dye Laser
Primary Purpose
Scar, Laser Therapy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser treatment with Purpuric settings
Laser treatment with Nonpurpuric settings
No treatment
Sponsored by
About this trial
This is an interventional treatment trial for Scar focused on measuring scar, laser therapy, lasers, pulsed dye
Eligibility Criteria
Inclusion Criteria:
- Patients requiring Mohs micrographic surgery or excisions for skin cancer or atypical nevi, with an expected post-excision scar of 4.5cm in length or more.
- Willing to participate.
- Able to give informed consent
Exclusion Criteria:
- Location of excision or Mohs surgery on the genitals, hands, or feet.
- Fitzpatrick skin type V or VI.
- Prior history of known light sensitivity.
Sites / Locations
- UCSD Perlman Ambulatory Center - Dermatology clinic
Outcomes
Primary Outcome Measures
Vancouver Scar Scale score
Secondary Outcome Measures
Subjective rating of pain on scale of 0 to 10
Cosmetic appearance of scar
Full Information
NCT ID
NCT00970671
First Posted
September 1, 2009
Last Updated
October 20, 2012
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00970671
Brief Title
Treatment of Surgical Scars Using the Pulsed Dye Laser
Official Title
Treatment of Surgical Scars With the 595nm Pulsed Dye Laser Using Purpuric and Nonpurpuric Parameters: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether treatment of fresh surgical scars with a pulsed dye laser using purpura-inducing settings will improve clinical appearance better than one using non-purpura-inducing settings or no treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar, Laser Therapy
Keywords
scar, laser therapy, lasers, pulsed dye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Laser treatment with Purpuric settings
Other Intervention Name(s)
Pulsed dye laser, 595nm VBeam, Candela
Intervention Description
Pulsed dye laser treatment at purpuric settings with pulse duration of 1.5msec.
Intervention Type
Other
Intervention Name(s)
Laser treatment with Nonpurpuric settings
Other Intervention Name(s)
Pulsed dye laser, 595nm VBeam, Candela
Intervention Description
Pulsed dye laser treatment with nonpurpuric settings with pulse duration 10msec.
Intervention Type
Other
Intervention Name(s)
No treatment
Intervention Description
No laser treatment
Primary Outcome Measure Information:
Title
Vancouver Scar Scale score
Time Frame
6weeks, 10weeks, and 18weeks after surgery
Secondary Outcome Measure Information:
Title
Subjective rating of pain on scale of 0 to 10
Time Frame
at each treatment visit: 2weeks, 6weeks, and 10weeks after surgery
Title
Cosmetic appearance of scar
Time Frame
6weeks, 10 weeks, and 18weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients requiring Mohs micrographic surgery or excisions for skin cancer or atypical nevi, with an expected post-excision scar of 4.5cm in length or more.
Willing to participate.
Able to give informed consent
Exclusion Criteria:
Location of excision or Mohs surgery on the genitals, hands, or feet.
Fitzpatrick skin type V or VI.
Prior history of known light sensitivity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie A Gladsjo, MD PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S. Brian Jiang, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Perlman Ambulatory Center - Dermatology clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Surgical Scars Using the Pulsed Dye Laser
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