Enhanced Efficacy Through Optimization of Hemoporfin-Photodynamic Therapy Parameters in Port-Wine Stains: A Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
研究概览
简要总结
- Background and Objectives Port-wine stain (PWS) is a congenital capillary malformation located in the upper dermis. Hematoporphyrin monomethyl ether (HMME)-mediated photodynamic therapy (PDT) has been established as a primary and effective treatment for PWS in China. However, treatment parameters, particularly irradiance and irradiation duration, vary widely in clinical practice based on physician experience, with a lack of evidence from controlled trials to guide optimization. The efficacy of PDT relies on a type II photochemical reaction, which is oxygen-dependent. High irradiance may lead to rapid oxygen depletion in the treatment area, potentially limiting therapeutic outcomes. This prospective, randomized controlled trial aims to compare the efficacy and safety of a low-irradiance, prolonged-duration protocol versus a high-irradiance, shorter-duration protocol in HMME-PDT for PWS, while maintaining an identical total light dose.
- Study Design
This was a single-center, randomized controlled, single-blind trial. The study protocol was approved by the Ethics Committee of The Second Affiliated Hospital of Xi'an Jiaotong University (Approval No. 2024219). A total of 33 pediatric patients (aged 3-12 years) with facial or neck PWS were enrolled and randomly assigned to one of two groups:
Low-Power Group (n=15): Received irradiation at 75 mW/cm² for 19 minutes per spot.
High-Power Group (n=18): Received irradiation at 84 mW/cm² for 17 minutes per spot.
Both groups received a single session of HMME-PDT with the same total light dose. All patients received an intravenous infusion of Hemoporfin at a dose of 5.0 mg/kg, followed by irradiation with a 532-nm LED green light. 3. Primary evaluation indicators
The primary efficacy endpoint was lesion clearance assessed at the 3-month follow-up using three independent methods:
Blinded Quartile Grading: Performed by two independent dermatologists based on high-resolution photographs.
Quantitative Lesion Area Reduction: The percentage reduction in the PWS area was calculated from VISIA complexion analysis system "redness" images using ImageJ software.
Erythema Index (EI) Analysis: The relative change in the EI (ΔEI%) between the lesion and normal skin was quantified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •·Clinical diagnosis of port-wine stain (PWS).
排除标准
- •concurrent syndromes such as Sturge-Weber or Klippel-Trenaunay syndrome;
- •a history of previous radiotherapy, photodynamic therapy, or any other intervention in the treatment area that might confound efficacy evaluation;
- •a known diagnosis of cutaneous photosensitivity, porphyria, or hypersensitivity to porphyrin-based drugs;
- •administration of photosensitizing medications, including but not limited to griseofulvin, retinoids, thiazide diuretics, sulfonamides, and tetracyclines, within 4 weeks prior to the study.
研究者
Weihui Zeng
Professor
Second Affiliated Hospital of Xi'an Jiaotong University