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

This study has been completed.

Sponsors and Collaborators: Mahidol University
Dermatological Society of Thailand
Information provided by: Mahidol University
ClinicalTrials.gov Identifier: NCT00142441
  Purpose

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


Condition Intervention
Keloids
Hypertrophic Scars
Device: Pulsed dye laser

MedlinePlus related topics:   Scars   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:   Effect of Pulse Width of a 595-Nm Flashlamp-Pumped Pulsed-Dye Laser on the Treatment Response of Keloidal and Hypertrophic Sternotomy Scars

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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).

Secondary Outcome Measures:
  • no

Estimated Enrollment:   19
Study Start Date:   June 2003
Estimated Study Completion Date:   December 2004

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.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142441

Locations
Thailand, -
Siriraj Hospital, Mahidol University    
      Bangkok, -, Thailand, 10700

Sponsors and Collaborators
Mahidol University
Dermatological Society of Thailand

Investigators
Principal Investigator:     Woraphong - Manuskiatti, M.D.     Siriraj Hospital, Mahidol University    
  More Information

Publications:

Study ID Numbers:   63/2003
First Received:   September 1, 2005
Last Updated:   September 1, 2005
ClinicalTrials.gov Identifier:   NCT00142441
Health Authority:   Thailand: Ethical Committee

Keywords provided by Mahidol University:
Pulsed dye laser  
Keloids  
Hypertrophic scars  
Pulse width  
Pulse duration  

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Hypertrophy
Cicatrix, Hypertrophic
Skin Diseases
Keloid
Connective Tissue Diseases
Cicatrix

Additional relevant MeSH terms:
Collagen Diseases

ClinicalTrials.gov processed this record on August 28, 2008




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