Maximizing Laser Therapy Success for Port-Wine Birthmarks in Pediatric Patients
NCT ID: NCT07183644
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-09-30
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All patients
Every patient will receive the 5 treatment modalities in their first laser treatment after enrollment in the study.
* At 5-7 weeks follow-up visit after the procedure, if no treatment modality is better than the other, then the surgeon will repeat the procedure with the 5 modalities, and the subject will have a 2nd follow-up appointment 5-7 weeks later. Continue treatment with 5 modalities and appropriate follow-up until Port Wine Birthmark (PWB) clearance, or,
* If any modality is seen to give best results at the first follow-up visit (5-7 weeks after the first procedure), then the next treatment will be only with that modality and will continue to have treatments with this modality and follow-up appointments (5-7 weeks after procedure) according to standard of care timelines for PWBs until the treatment is not improving the PWB anymore or until the PWB is no longer visible.
Pulse Dye laser
Pulse Dye Laser (PDL) standard settings. This is the same procedure children would receive as standard of care if these individuals were not participating in this study.
The surgeon will perform 1 pass with the PDL over the area of the Port wine birthmark (PWB).
Pulse Dye Laser (PDL) pulse width stacking
This procedure is used for some patients as standard of care depending on the severity and depth of the lesion.
The surgeon will perform 3 passes with the PDL over the PWB, gradually increasing the pulse duration with each pass to effectively target both superficial and deeper blood vessels.
Pulse Dye Laser (PDL) followed by Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet laser) laser.
The combination of these two lasers is one of the investigational treatments. The surgeon will perform 1 pass per laser over the PWB. The 1st pass will be with the PDL to target the blood vessels closer to the top of the skin, followed by a 2nd pass with the Nd:YAG laser to target the blood vessels that deeper in the skin.
IPL (Intense Pulsed Light) followed by Pulse Dye Laser (PDL)
The surgeon will perform 1 pass with the IPL followed by 1 pass with the PDL over the PWB
Cupping followed by Pulse Dye Laser (PDL)
The combination of these modalities is one of the experimental procedures. The surgeon will place a small suction cup over the PWB target region of the PDL for a few seconds to stop the blood flow and accumulate the blood in that spot. The PDL treatment will then quickly proceed. Since the PDL targets red blood cells, it will allow the laser to target the pooled blood in the abnormal blood vessels better.
Interventions
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Pulse Dye laser
Pulse Dye Laser (PDL) standard settings. This is the same procedure children would receive as standard of care if these individuals were not participating in this study.
The surgeon will perform 1 pass with the PDL over the area of the Port wine birthmark (PWB).
Pulse Dye Laser (PDL) pulse width stacking
This procedure is used for some patients as standard of care depending on the severity and depth of the lesion.
The surgeon will perform 3 passes with the PDL over the PWB, gradually increasing the pulse duration with each pass to effectively target both superficial and deeper blood vessels.
Pulse Dye Laser (PDL) followed by Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet laser) laser.
The combination of these two lasers is one of the investigational treatments. The surgeon will perform 1 pass per laser over the PWB. The 1st pass will be with the PDL to target the blood vessels closer to the top of the skin, followed by a 2nd pass with the Nd:YAG laser to target the blood vessels that deeper in the skin.
IPL (Intense Pulsed Light) followed by Pulse Dye Laser (PDL)
The surgeon will perform 1 pass with the IPL followed by 1 pass with the PDL over the PWB
Cupping followed by Pulse Dye Laser (PDL)
The combination of these modalities is one of the experimental procedures. The surgeon will place a small suction cup over the PWB target region of the PDL for a few seconds to stop the blood flow and accumulate the blood in that spot. The PDL treatment will then quickly proceed. Since the PDL targets red blood cells, it will allow the laser to target the pooled blood in the abnormal blood vessels better.
Eligibility Criteria
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Inclusion Criteria
* Age Range: 2mo to 18 years of age.
* Stable PWS: The port wine stain should be stable, meaning there is no active inflammation or infection present, and it should not be changing in size or color due to factors like injury or disease.
* signed Consent: For ethical reasons, participants must be able to provide informed consent. In the case of minors, consent would generally be required from a parent or legal guardian.
General Health: Participants should generally be in good health, with no contraindications for laser therapy, such as certain skin conditions, infections, or hypersensitivity to light.
Exclusion Criteria
* active skin infections or inflammation
* recent laser therapy
* use of Photosensitizing medications
* participation in other laser studies
2 Months
18 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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James Seaward
Board Certified Plastic Surgeon
Principal Investigators
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James Seaward, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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Children's Medical Center
Dallas, Texas, United States
Children's Medical Center
Plano, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Chen JK, Ghasri P, Aguilar G, van Drooge AM, Wolkerstorfer A, Kelly KM, Heger M. An overview of clinical and experimental treatment modalities for port wine stains. J Am Acad Dermatol. 2012 Aug;67(2):289-304. doi: 10.1016/j.jaad.2011.11.938. Epub 2012 Feb 3.
Jasim ZF, Handley JM. Treatment of pulsed dye laser-resistant port wine stain birthmarks. J Am Acad Dermatol. 2007 Oct;57(4):677-82. doi: 10.1016/j.jaad.2007.01.019. Epub 2007 Jul 19.
Lee JW, Chung HY. Capillary Malformations (Portwine Stains) of the Head and Neck: Natural History, Investigations, Laser, and Surgical Management. Otolaryngol Clin North Am. 2018 Feb;51(1):197-211. doi: 10.1016/j.otc.2017.09.004.
Ahcan U, Zorman P, Recek D, Ralca S, Majaron B. Port wine stain treatment with a dual-wavelength Nd:Yag laser and cryogen spray cooling: a pilot study. Lasers Surg Med. 2004;34(2):164-7. doi: 10.1002/lsm.10252.
Li G, Lin T, Wu Q, Zhou Z, Gold MH. Clinical analysis of port wine stains treated by intense pulsed light. J Cosmet Laser Ther. 2010 Feb;12(1):2-6. doi: 10.3109/14764170903449778.
Other Identifiers
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Stu-2024-1203
Identifier Type: -
Identifier Source: org_study_id
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