NCT04106258已完成4 期
A Pilot Study of Hemoporfin Photodynamic Therapy in Children (2-7 Years Old) With Port-wine Stain
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年5月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
This pilot study aims to evaluate the safety and efficacy of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS）in 2-7 years old children. The pharmacokinetic behavior and pharmacokinetic parameters of hemoporfin in children will be investigated as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with clinical diagnosis of PWS；
- •≥2 years old and <7 years old；
- •The guardians agreed to voluntarily participate in this study and signed the informed consent agreement
排除标准
- •Therapy area located outside of head and neck;
- •Other skin diseases that might interfere with the efficacy evaluation;
- •Patients with respiratory disease, severe pulmonary dysfunction, history of airway hyperresponsiveness, or family history of suspected malignant hyperthermia;
- •Preexist scars in the treatment area caused by previous treatment, which might interfere with the efficacy and safety evaluation;
- •with allergic diseases; known to be allergic to eggs, milk or soy protein; known to have skin photoallergies, porphyria or known allergic history of experimental drugs (porphyrins) and chemically structure similar drugs; known allergic history of anesthetics; allergic constitution;
- •Cicatricial constitution;
- •Immunocompromised conditions or need long-term use of glucocorticoids and immunosuppressive agents;
- •Electrocardiographic abnormalities or organic heart diseases;
- •Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin > 1.5 upper limit of normal [ULN], or serum creatinine or blood urea nitrogen > 1.5 ULN);
- •Coagulation disorders;
- •Patients with severe neurological, psychiatric, endocrine and cardiovascular diseases; with epilepsy history or recent epileptic seizures;
- •Be evaluated not suitable for anaesthesia by risk assessment before anaesthesia；
- •Previous therapy of PWS within the last 4 weeks;
- •Participation in any clinical studies within the last 4 weeks;
- •Be judged not suitable to participate the study by the investigators
研究组 & 干预措施
low light dose
Experimental
PDT is applied to the patients at low light dose : power density of 60mW/cm2 for 20 minutes
干预措施: Hemoporfin PDT (Drug)
high light dose
Experimental
PDT is applied to the patients at high light dose : power density of 75mW/cm2 for 20 minutes
干预措施: Hemoporfin PDT (Drug)
结局指标
主要结局
Response rate
时间窗: week 8
proportion of patients achieving at least some improvement (color blanching from the baseline \>= 20%)
Incidence of adverse events and adverse reactions
时间窗: up to 24 weeks after the treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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