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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Change in Port Wine Birthmark (PWB) color in participants - Pre Operative [Time frame: Baseline]
• Change in Port Wine Birthmark (PWB) color in participants - Post Operative [Time frame: 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Children's Medical Center — Dallas
• Children's Medical Center — Plano

Publications

• Chen JK, Ghasri P, Aguilar G, van Drooge AM, Wolkerstorfer A, Kelly KM, Heger M. An overview of clinical and experimental treatment modalities for port wine stains. J Am Acad Dermatol. 2012 Aug;67(2):289-304. doi: 10.1016/j.jaad.2011.11.938. Epub 2012 Feb 3. PMID 22305042
• Jasim ZF, Handley JM. Treatment of pulsed dye laser-resistant port wine stain birthmarks. J Am Acad Dermatol. 2007 Oct;57(4):677-82. doi: 10.1016/j.jaad.2007.01.019. Epub 2007 Jul 19. PMID 17658196
• Lee JW, Chung HY. Capillary Malformations (Portwine Stains) of the Head and Neck: Natural History, Investigations, Laser, and Surgical Management. Otolaryngol Clin North Am. 2018 Feb;51(1):197-211. doi: 10.1016/j.otc.2017.09.004. PMID 29217063
• Ahcan U, Zorman P, Recek D, Ralca S, Majaron B. Port wine stain treatment with a dual-wavelength Nd:Yag laser and cryogen spray cooling: a pilot study. Lasers Surg Med. 2004;34(2):164-7. doi: 10.1002/lsm.10252. PMID 15004829
• Li G, Lin T, Wu Q, Zhou Z, Gold MH. Clinical analysis of port wine stains treated by intense pulsed light. J Cosmet Laser Ther. 2010 Feb;12(1):2-6. doi: 10.3109/14764170903449778. PMID 20085450

Identifiers

NCT: NCT07183644 · STU-2024-1203

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗