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

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Port Wine Stains

Treatments: Device: Pulse Dye laser; Device: Pulse Dye Laser (PDL) pulse width stacking; Device: Cupping followed by Pulse Dye Laser (PDL); 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)

Study type: Interventional

Funder types: Other

Identifiers

NCT07183644

Stu-2024-1203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 2 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

All patients

Active Comparator group

Description:

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.

Treatment:

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

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

Device: Cupping followed by Pulse Dye Laser (PDL)

Device: Pulse Dye Laser (PDL) pulse width stacking

Device: Pulse Dye laser