KeloidsNCT00142441
Effect of Pulse Width on Scar Treatment Using a 595-nm Pulsed Dye Laser
A study testing Pulsed dye laser in people with Keloids and Hypertrophic Scars, run by Mahidol University at 1 site in Thailand.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Keloids, Hypertrophic Scars
- What is being tested?
- Pulsed dye laser
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2003to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
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
To investigate the effect of pulse width on the treatment response of keloidal and hypertrophic sternotomy scars to a 595-nm pulsed dye laser
Read the 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.
- Conditions
- Keloids, Hypertrophic Scars
- Being tested
- Pulsed dye laser
- Keywords
- Pulsed dye laser, Keloids, Hypertrophic scars, Pulse width, Pulse duration
- Medical subject headings
- Keloid, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed dye laserDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJun 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeloidsStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 19 participants
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Dermatological Society of Thailand
- Investigators
- Woraphong - Manuskiatti, M.D., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142441
- Sponsor's protocol ID
- 63/2003
- Status last verified
- Jun 2016
- First submitted
- 1 Sep 2005
- Last updated
- 3 Jun 2016
- Results posted
- No
Publications
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.
PubMed 12224975
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00142441
- Acronym / sponsor ID
- 63/2003
- Conditions
- Keloids, Hypertrophic Scars
- Keywords
- Pulsed dye laser, Keloids, Hypertrophic scars, Pulse width, Pulse duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Dermatological Society of Thailand
- Study start
- Jun 2003
- Study completion
- Dec 2004
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed dye laser | Device | – |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Background: PubMed 12224975Manuskiatti 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.
Related trials for Keloids
Not yet recruiting
Fractional Radiofrequency With Streroids Versus Fractional CO2 Laser With Steroids in the Treatment of Keloids
Keloids
Active, not recruiting
Transdermal Versus Intralesional Betamethasone for Keloids
Keloid
RecruitingPhase 2
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
Keloid
Recruiting
Radiotherapy for Keloids
Keloid
Not yet recruitingPhase 2
siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars
Keloid of Ear Lobe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woraphong - Manuskiatti, M.D. principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed dye laser in people with Keloids and Hypertrophic Scars, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00142441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.