Treatment of Surgical Scars Using the Pulsed Dye Laser
Treatment of Surgical Scars With the 595nm Pulsed Dye Laser Using Purpuric and Nonpurpuric Parameters: A Comparative Study
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedFirst Posted
Study publicly available on registry
September 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedOctober 23, 2012
October 1, 2012
1.2 years
September 1, 2009
October 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vancouver Scar Scale score
6weeks, 10weeks, and 18weeks after surgery
Secondary Outcomes (2)
Subjective rating of pain on scale of 0 to 10
at each treatment visit: 2weeks, 6weeks, and 10weeks after surgery
Cosmetic appearance of scar
6weeks, 10 weeks, and 18weeks after surgery
Interventions
Pulsed dye laser treatment at purpuric settings with pulse duration of 1.5msec.
Pulsed dye laser treatment with nonpurpuric settings with pulse duration 10msec.
No laser treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Location of excision or Mohs surgery on the genitals, hands, or feet.
- Fitzpatrick skin type V or VI.
- Prior history of known light sensitivity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSD Perlman Ambulatory Center - Dermatology clinic
La Jolla, California, 92037, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie A Gladsjo, MD PhD
University of California, San Diego
- PRINCIPAL INVESTIGATOR
S. Brian Jiang, MD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Instructor
Study Record Dates
First Submitted
September 1, 2009
First Posted
September 2, 2009
Study Start
September 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
October 23, 2012
Record last verified: 2012-10