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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

severe allergies to anesthesia

active skin infections or inflammation

recent laser therapy

use of Photosensitizing medications

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: All patientsActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

Change in Port Wine Birthmark (PWB) color in participants - Pre Operative

Prior to treatment, the PWB will be documented photographically. Images taken will be transformed in to the L a\*b\* colorspace (also known as the red green color axis), and regions of interest defined on the photographs corresponding with the areas treated by each modality, as well as a region of interest adjacent to the treated area, to act as a control to correct for skin changes unrelated to the treatment. The axis is representative of color chromaticity and is measured in a range of -128 to 127. Positive values are indicative of red, and negative values are indicative of green. The quantitative values of the a\* channel in the L a\*b\* colorspace will be used as a measure of the PWB intensity and each treated area will be compared with the corresponding area pre-treatment, using the difference in a\* values to determine the treatment effectiveness.

Time frame
Baseline
2

Change in Port Wine Birthmark (PWB) color in participants - Post Operative

Post-operatively, the treated area will once more be documented photographically. Images taken will be transformed in to the L a\*b\* colorspace (also known as the red green color axis), and regions of interest defined on the photographs corresponding with the areas treated by each modality, as well as a region of interest adjacent to the treated area, to act as a control to correct for skin changes unrelated to the treatment. The axis is representative of color chromaticity and is measured in a range of -128 to 127. Positive values are indicative of red, and negative values are indicative of green. The quantitative values of the a\* channel in the L a\*b\* colorspace will be used as a measure of the PWB intensity and each treated area will be compared with the corresponding area pre-treatment, using the difference in a\* values to determine the treatment effectiveness.

Time frame
6 weeks

Secondary outcomes

Other outcomes

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