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Treatment of Surgical Scars Using the Pulsed Dye Laser

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ClinicalTrials.gov Identifier: NCT00970671
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : October 23, 2012
Sponsor:
Information provided by (Responsible Party):
Julie Akiko Gladsjo, University of California, San Diego

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : September 2009
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources


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


Primary Outcome Measures :
  1. Vancouver Scar Scale score [ Time Frame: 6weeks, 10weeks, and 18weeks after surgery ]

Secondary Outcome Measures :
  1. Subjective rating of pain on scale of 0 to 10 [ Time Frame: at each treatment visit: 2weeks, 6weeks, and 10weeks after surgery ]
  2. Cosmetic appearance of scar [ Time Frame: 6weeks, 10 weeks, and 18weeks after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Julie Akiko Gladsjo, Clinical Instructor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00970671     History of Changes
Other Study ID Numbers: 090690
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012

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