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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Active Comparator | Every patient will receive the 5 treatment modalities in their first laser treatment after enrollment in the study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | 6 weeks |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James R Seaward, MD | Contact | 214 456 5250 | james.seaward@utsouthwestern.edu | |
| Lauren Bailey, MS | Contact | lauren.bailey2@utsouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| James Seaward, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Medical Center | Recruiting | Dallas | Texas | 75207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22305042 | Background | 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. | |
| 17658196 | Background | 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. |
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We will share the information based on the results of our study and a careful assessment of its potential value in treating this condition. Our decision will consider how the findings contribute to advancing knowledge and improving patient care.
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| 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. |
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| 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. |
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| 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 |
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| 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. |
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| Children's Medical Center | Recruiting | Plano | Texas | 75024 | United States |
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| 29217063 | Background | 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. |
| 15004829 | Background | 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. |
| 20085450 | Background | 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. |
| ID | Term |
|---|---|
| D018324 | Hemangioma, Capillary |
| D019339 | Port-Wine Stain |
| ID | Term |
|---|---|
| D006391 | Hemangioma |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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