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

This study has been completed.
Sponsor:
Collaborator:
Dermatological Society of Thailand
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00142441
First received: September 1, 2005
Last updated: NA
Last verified: May 2003
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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:

MedlinePlus related topics: Scars
U.S. FDA Resources

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

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:

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

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

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

ClinicalTrials.gov processed this record on June 18, 2013