search
Back to results

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

Primary Purpose

Keloids, Hypertrophic Scars

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Pulsed dye laser
Sponsored by
Mahidol University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keloids focused on measuring Pulsed dye laser, Keloids, Hypertrophic scars, Pulse width, Pulse duration

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Medicine Siriraj Hospital

Outcomes

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).

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
June 1, 2016
Sponsor
Mahidol University
Collaborators
Dermatological Society of Thailand
search

1. Study Identification

Unique Protocol Identification Number
NCT00142441
Brief Title
Effect of Pulse Width on Scar Treatment Using a 595-nm Pulsed Dye Laser
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Mahidol University
Collaborators
Dermatological Society of Thailand

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloids, Hypertrophic Scars
Keywords
Pulsed dye laser, Keloids, Hypertrophic scars, Pulse width, Pulse duration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
19 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Pulsed dye laser
Primary Outcome Measure Information:
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woraphong - Manuskiatti, M.D.
Organizational Affiliation
Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
12224975
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs