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

NCT00142441 | Completed

• 1 other identifier: 63/2003
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Keloids; Hypertrophic Scars

Keywords

Pulsed dye laser; Keloids; Hypertrophic scars; Pulse width; Pulse duration

Outcome Measures

Primary Outcomes (1)

• 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).

Interventions

Pulsed dye laser DEVICE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead
• Dermatological Society of Thailand: collaborator

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related 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. doi: 10.1001/archderm.138.9.1149.

  PMID: 12224975 BACKGROUND

MeSH Terms

Conditions

Keloid; Cicatrix, Hypertrophic

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Woraphong - Manuskiatti, M.D.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: June 1, 2003
• Study Completion: December 1, 2004
• Last Updated: June 3, 2016

Record last verified: 2016-06

Locations

TH (1)