NCT07183644

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 2 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Port Wine Stains

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study