Maximizing Laser Therapy Success for Port-Wine Birthmarks in Pediatric Patients

NCT07183644 | Not Yet Recruiting FDA Device

• 1 other identifier: Stu-2024-1203
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

In this study the investigators aim to optimize Port-Wine-Birthmark (PBW) laser therapy in children in order to reduce the number of laser treatments required for clearance and improve outcomes for refractory cases. This approach also seeks to reduce the frequency with which children require general anesthesia for treatment.

Conditions

Port Wine Stains

Keywords

combined laser therapy; PDL; Nd:YAG laser; port wine stain; port wine birthmark

Outcome Measures

Primary Outcomes (2)

• Change in Port Wine Birthmark (PWB) color in participants - Pre Operative

  Prior to treatment, the PWB will be documented photographically. Images taken will be transformed in to the L a\*b\* colorspace (also known as the red green color axis), and regions of interest defined on the photographs corresponding with the areas treated by each modality, as well as a region of interest adjacent to the treated area, to act as a control to correct for skin changes unrelated to the treatment. The axis is representative of color chromaticity and is measured in a range of -128 to 127. Positive values are indicative of red, and negative values are indicative of green. The quantitative values of the a\* channel in the L a\*b\* colorspace will be used as a measure of the PWB intensity and each treated area will be compared with the corresponding area pre-treatment, using the difference in a\* values to determine the treatment effectiveness.

  Baseline

• Change in Port Wine Birthmark (PWB) color in participants - Post Operative

  Post-operatively, the treated area will once more be documented photographically. Images taken will be transformed in to the L a\*b\* colorspace (also known as the red green color axis), and regions of interest defined on the photographs corresponding with the areas treated by each modality, as well as a region of interest adjacent to the treated area, to act as a control to correct for skin changes unrelated to the treatment. The axis is representative of color chromaticity and is measured in a range of -128 to 127. Positive values are indicative of red, and negative values are indicative of green. The quantitative values of the a\* channel in the L a\*b\* colorspace will be used as a measure of the PWB intensity and each treated area will be compared with the corresponding area pre-treatment, using the difference in a\* values to determine the treatment effectiveness.

  6 weeks

Study Arms (1)

All patients

ACTIVE COMPARATOR

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.

Device: Pulse Dye laser; Device: Pulse Dye Laser (PDL) pulse width stacking; Device: Pulse Dye Laser (PDL) followed by Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet laser) laser.; Device: IPL (Intense Pulsed Light) followed by Pulse Dye Laser (PDL); Device: Cupping followed by Pulse Dye Laser (PDL)

Interventions

Pulse Dye laser DEVICE

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).

All patients

Pulse Dye Laser (PDL) pulse width stacking DEVICE

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.

All patients

Pulse Dye Laser (PDL) followed by Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet laser) laser. DEVICE

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.

All patients

IPL (Intense Pulsed Light) followed by Pulse Dye Laser (PDL) DEVICE

The surgeon will perform 1 pass with the IPL followed by 1 pass with the PDL over the PWB

All patients

Cupping followed by Pulse Dye Laser (PDL) DEVICE

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.

All patients

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Port Wine Stain.
• 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.

You may not qualify if:

• severe allergies to anesthesia
• active skin infections or inflammation
• recent laser therapy
• use of Photosensitizing medications
• participation in other laser studies

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Children's Medical Center

Dallas, Texas, 75207, United States

Location

Children's Medical Center

Plano, Texas, 75024, United States

Location

Related Publications (5)

• 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.

  PMID: 22305042 BACKGROUND

• 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.

  PMID: 17658196 BACKGROUND

• 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.

  PMID: 29217063 BACKGROUND

• 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.

  PMID: 15004829 BACKGROUND

• 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.

  PMID: 20085450 BACKGROUND

MeSH Terms

Conditions

Hemangioma, Capillary; Port-Wine Stain

Interventions

Lasers, Solid-State; Lasers

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• James Seaward, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James R Seaward, MD

CONTACT

214 456 5250; james.seaward@utsouthwestern.edu

Lauren Bailey, MS

CONTACT

lauren.bailey2@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Board Certified Plastic Surgeon

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)