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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014