Maximizing Laser Therapy Success for Port-Wine Birthmarks in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Change in Port Wine Birthmark (PWB) color in participants - Pre Operative
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •severe allergies to anesthesia
- •active skin infections or inflammation
- •recent laser therapy
- •use of Photosensitizing medications
- •participation in other laser studies
研究组 & 干预措施
All patients
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.
干预措施: Pulse Dye laser (Device)
All patients
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.
干预措施: Pulse Dye Laser (PDL) pulse width stacking (Device)
All patients
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.
干预措施: Pulse Dye Laser (PDL) followed by Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet laser) laser. (Device)
All patients
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.
干预措施: IPL (Intense Pulsed Light) followed by Pulse Dye Laser (PDL) (Device)
All patients
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.
干预措施: Cupping followed by Pulse Dye Laser (PDL) (Device)
结局指标
主要结局
Change in Port Wine Birthmark (PWB) color in participants - Pre Operative
时间窗: Baseline
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.
Change in Port Wine Birthmark (PWB) color in participants - Post Operative
时间窗: 6 weeks
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.
次要结局
未报告次要终点
研究者
James Seaward
Board Certified Plastic Surgeon
University of Texas Southwestern Medical Center