Treatment of Surgical Scars Using the Pulsed Dye Laser

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Akiko Gladsjo, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00970671
First received: September 1, 2009
Last updated: October 20, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Scar
Laser Therapy
Other: Laser treatment with Purpuric settings
Other: Laser treatment with Nonpurpuric settings
Other: No treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Surgical Scars With the 595nm Pulsed Dye Laser Using Purpuric and Nonpurpuric Parameters: A Comparative Study

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Vancouver Scar Scale score [ Time Frame: 6weeks, 10weeks, and 18weeks after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective rating of pain on scale of 0 to 10 [ Time Frame: at each treatment visit: 2weeks, 6weeks, and 10weeks after surgery ] [ Designated as safety issue: No ]
  • Cosmetic appearance of scar [ Time Frame: 6weeks, 10 weeks, and 18weeks after surgery ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Laser treatment with Purpuric settings
    Pulsed dye laser treatment at purpuric settings with pulse duration of 1.5msec.
    Other Name: Pulsed dye laser, 595nm VBeam, Candela
    Other: Laser treatment with Nonpurpuric settings
    Pulsed dye laser treatment with nonpurpuric settings with pulse duration 10msec.
    Other Name: Pulsed dye laser, 595nm VBeam, Candela
    Other: No treatment
    No laser treatment
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970671

Locations
United States, California
UCSD Perlman Ambulatory Center - Dermatology clinic
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Julie A Gladsjo, MD PhD University of California, San Diego
Principal Investigator: S. Brian Jiang, MD University of California, San Diego
  More Information

No publications provided

Responsible Party: Julie Akiko Gladsjo, Clinical Instructor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00970671     History of Changes
Other Study ID Numbers: 090690
Study First Received: September 1, 2009
Last Updated: October 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
scar
laser therapy
lasers, pulsed dye

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014