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

September 1, 2005
September 1, 2005
June 2003
Not Provided
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).
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Pulse Width on Scar Treatment Using a 595-Nm Pulsed Dye Laser
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Keloids
  • Hypertrophic Scars
Device: Pulsed dye laser
Not Provided
Manuskiatti W, Fitzpatrick RE. Treatment response of keloidal and hypertrophic sternotomy scars: comparison among intralesional corticosteroid, 5-fluorouracil, and 585-nm flashlamp-pumped pulsed-dye laser treatments. Arch Dermatol. 2002 Sep;138(9):1149-55.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
December 2004
Not Provided

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.
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00142441
63/2003
Not Provided
Not Provided
Mahidol University
Dermatological Society of Thailand
Principal Investigator: Woraphong - Manuskiatti, M.D. Siriraj Hospital, Mahidol University
Mahidol University
May 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP