Recruiting

PBW Laser Therapy

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07183644

Conditions

Port Wine Stains

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Pulse Dye laser

Pulse Dye Laser (PDL) pulse width stacking

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

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

Cupping followed by Pulse Dye Laser (PDL)

Study Details

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

Study ID

NCT07183644

Start date

Jul, 2026

Status verified date

May, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

Interventions

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.

Primary outcome measure

  • Change in Port Wine Birthmark (PWB) color in participants - Pre Operative [ Time Frame: Baseline ]
  • Change in Port Wine Birthmark (PWB) color in participants - Post Operative [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

James R Seaward, MD

214 456 5250james.seaward@utsouthwestern.edu

Lauren Bailey, MS

lauren.bailey2@utsouthwestern.edu

Locations

Children's Medical Center

Recruiting

Dallas, Texas, United States, 75207

Contacts

James R. Seaward, MD

214 456 5250james.seaward@utsouthwestern.edu

Children's Medical Center

Recruiting

Plano, Texas, United States, 75024

Contacts

James R. Seaward, MD

214 456 5250james.seaward@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jun 5, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-06-05.