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

Conditions

• Port Wine Stains

Eligibility Criteria

Sex

ALL

Age

2 Months - 18 Years

Healthy Volunteers

Not accepted

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).
• 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.
• 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.
• 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
• 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.

Study Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

May 2026

Primary completion

Sep 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

200 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• James R Seaward, MD
  214 456 5250
  [email protected]
• Lauren Bailey, MS
  [email protected]

Locations (2)

Find similar trials in Dallas, TX

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