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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00142441
First Posted: September 2, 2005
Last Update Posted: June 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dermatological Society of Thailand
Information provided by:
Mahidol University
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
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

Resource links provided by NLM:


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).

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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00142441


Locations
Thailand
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Dermatological Society of Thailand
Investigators
Principal Investigator: Woraphong - Manuskiatti, M.D. Siriraj Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00142441     History of Changes
Other Study ID Numbers: 63/2003
First Submitted: September 1, 2005
First Posted: September 2, 2005
Last Update Posted: June 3, 2016
Last Verified: June 2016

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

Additional relevant MeSH terms:
Hypertrophy
Keloid
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes