Treatment of Surgical Scars Using the Pulsed Dye Laser

October 20, 2012 updated by: Julie Akiko Gladsjo, University of California, San Diego

Treatment of Surgical Scars With the 595nm Pulsed Dye Laser Using Purpuric and Nonpurpuric Parameters: A Comparative Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UCSD Perlman Ambulatory Center - Dermatology clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vancouver Scar Scale score
Time Frame: 6weeks, 10weeks, and 18weeks after surgery
6weeks, 10weeks, and 18weeks after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 20, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 090690

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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