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

Hypertrophic Scars Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142441
• Other study ID #: 63/2003
• Status: Completed
• Phase: N/A
• First received: September 1, 2005
• Last updated: June 1, 2016
• Start date: June 2003
• Est. completion date: December 2004

Study information

• Verified date: June 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scars
• Hypertrophy
• Keloids

Intervention

Device:
• Pulsed dye laser

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Dermatological Society of Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).