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

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

Interventions

DEVICE

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).

DEVICE

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.

DEVICE

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.

DEVICE

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

DEVICE

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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• James Seaward, MD · UT Southwestern Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Months

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2028-09-30

Completion

2028-09-30

FDA Device

Yes

Countries

• United States

Study Locations