Jet-Injection Assisted Photodynamic Therapy for Basal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Clinical evaluation of local skin responses on Day 0
研究概览
简要总结
The purpose of this study is to find out whether injecting ALA into the skin with a jet-injection device and activating the drug with light is a safe treatment that causes few or mild side effects in people with basal cell carcinoma.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who meet all of the following criteria are eligible to participate in this study
- •Histologically-verified, previously untreated low-risk mixed superficial and nodular BCC(s) or nodular BCC(s) < 1 cm in diameter on scalp, extremities, or trunk.
- •≥ 18 years of age
- •Owner of a smartphone (Android or iPhone). Patients without a working smartphone will not be considered eligible for this study.
- •Being able to download application on their phone
- •Being able to take pictures of their treated BCC(s) (with or without assistance)
- •Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment. (Female subjects are considered of childbearing potential unless they have been hysterectomized or have undergone tubal ligation or have been post-menopausal for at least one year prior to the first visit)
- •Legally competent, able to give verbal and written informed consent
- •Subject in good general health and willing to participate comply with protocol requirements.
- •Superficial and nodular BCC(s)
排除标准
- •Subjects meeting any one of the following criteria are not eligible to participate in this study
- •High-risk BCC(s) (H area, >1 cm in M area, or >2 cm in L area)
- •BCC(s) subtype morpheaform
- •Diagnosed with gorlin syndrome
- •Receiving immunosuppressive medication
- •Subjects with a known allergy to ALA
- •Individuals with other interfering skin diseases in the area of treatment
- •Subjects with a tattoo in the treatment area which may interfere with or confound the evaluation of the study
- •Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator
- •Lactating or pregnant women
- •Patient who are taking prescription pain medications or can not stop OTC pain medications.
研究组 & 干预措施
Tumor Excision, No Illumination
The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy.
干预措施: Jet injection of ALA (Drug)
Tumor Excision, No Illumination
The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy.
干预措施: Surgical excision (Procedure)
Tumor Excision, No Illumination
The first four patients will not receive illumination but have their tumors excised after jet-injection (AirGent2.0) of ALA (Levulan Kerastick), and 3h incubation; this will be done to assess biodistribution of ALA through fluorescence microscopy.
干预措施: Incubation (Other)
PDT treatment with jet-injections
Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks.
干预措施: Surgical excision (Procedure)
PDT treatment with jet-injections
Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks.
干预措施: Illumination (Procedure)
PDT treatment with jet-injections
Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks.
干预措施: Incubation (Other)
PDT treatment with jet-injections
Patient 5-16 will receive PDT treatment with jet-injections of ALA followed by 3h incubation under occlusion and thereafter illumination with red light (total dose 75 J/cm2). In patient 5-16, the PDT treatment will be repeated after 2 weeks.
干预措施: Jet injection of ALA (Drug)
结局指标
主要结局
Clinical evaluation of local skin responses on Day 0
时间窗: Day 1
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 0 (PDT treatment #1)
Clinical evaluation of local skin responses on Day 3
时间窗: Day 3
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 3
Clinical evaluation of local skin responses on Day 17
时间窗: Day 17
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 17
Clinical evaluation of local skin responses on Day 14
时间窗: Day 14
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 14 (PDT treatment #2)
Clinical evaluation of local skin responses 3 months post treatment
时间窗: 3 months after treatment
Clinical evaluation of local skin responses on a 0-4 point scale will be performed 3 months post treatment
次要结局
未报告次要终点