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NCT07183644NARecruiting

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

University of Texas Southwestern Medical Center

Start Date

7/1/2026

Completion Date

9/1/2028

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.

Detailed Description

Participants will undergo up to two laser treatment sessions on the Port-Wine Birthmark (PWB), in which five treatment modalities will be applied. The modality with the best outcomes will be used for subsequent treatments until the PWB is cleared or treatment with that modality reaches an outcome plateau, as determined by the treating physician. If no further outcome response is observed with that modality, the patient will undergo a second round of the five different modalities to determine if there are differences in efficacy. The treatment modality showing the best response will then be continued. Patient outcomes will then be analyzed to determine if there are significant differences between treatment modalities as well as among primary treatment patients and refractory cases.

Eligibility Criteria

Age Range: No minimum to 18 years

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

Interventions

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)

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Conditions

Port Wine Stains

Locations

Children's Medical Center

Dallas, Texas 75207

United States

Children's Medical Center

Plano, Texas 75024

United States