Effect of Pulse Width on Scar Treatment Using a 595-nm Pulsed Dye Laser

June 1, 2016 updated by: Mahidol University

Effect of Pulse Width of a 595-nm Flashlamp-pumped Pulsed-dye Laser on the Treatment Response of Keloidal and Hypertrophic Sternotomy Scars

To investigate the effect of pulse width on the treatment response of keloidal and hypertrophic sternotomy scars to a 595-nm pulsed dye laser

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The pulse width of the previous model of pulsed dye laser was fixed at 0.45 millisecond, whereas the pulse widths of the latest model of PDL are tunable ranging between 0.45-40 milliseconds. The long-pulsed PDL has been proven to be safe and more effective in treating certain vascular abnormalities including adult port-wine-stain and small leg vein.9-12 In the present study, we would like to investigate the effect of pulse widths on the treatment response of keloidal and hypertrophic sternotomy scars to the 595-nm PDL.

Study Type

Interventional

Enrollment

19

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

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy, adult subjects aged above 18.
  • Subjects must be in good health as determined by the investigator.
  • Presence of keloidal and hypertrophic sternotomy scars for at least 6 months
  • Subjects must have no prior treatment of the scar within 1 month before the first treatment session.
  • Subject or authorized representative must sign Informed Consent Form prior to study enrollment.

Exclusion Criteria:

  • Female subjects known to be pregnant.
  • Subjects with scleroderma, connective tissue disorders, hematologic disorders, hepatitis, infection, or uncontrolled diabetes mellitus.
  • Subjects with photosensitive dermatoses such as Systemic Lupus Erythematosus (SLE)
  • Subjects with a documented positive HIV test.
  • Subjects who are on any types of anticoagulants.
  • Subjects who are habitual smokers of cigars, pipe tobacco, or cigarettes.
  • Subjects with history of radiation treatment at treatment sites.
  • Subjects who use of any types of treatment of scars at the treatment site within one month before the first treatment visit.
  • Subjects who are on medication that may interfere with wound healing or hemostasis.
  • Subjects that have not signed the Informed Consent Form.

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: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
scar volume, scar height, scar color, scar elasticity were measured at baseline (day of laser treatment 1), Week 4 (day of laser treatment 2), Week 8 (day of laser treatment 3), Week 24 (12 weeks after the last treatment).

Collaborators and Investigators

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

Sponsor

Mahidol University

Collaborators

Dermatological Society of Thailand

Investigators

  • Principal Investigator: Woraphong - Manuskiatti, M.D., Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2003

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 1, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 63/2003

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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