Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: Hexylaminolevulinate and Aminolevulinic Acid Nano Emulsion Versus Methylaminolevulinate
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Histological lesion clearance
研究概览
简要总结
This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic therapy of superficially growing basal cell carcinomas. Study is conducted using randomised prospective double blinded comparing design. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up before and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
详细描述
Study recruits volunteering patients, who are referred to the department of dermatology and allergology, Päijät-Häme Central Hospital, Lahti, with 99 clinically assessed superficial basal cell carcinoma on the body area, not face and scalp. Diagnoses is confirmed histologically by punch biopsies and hyperspectral images are taken before the biopsies. The lesions are randomised in three groups: interventions HAL and BF-200 ALA and comparator MAL. Photodynamic therapy is given by the standard procedure. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up, with Wood's light, digital camera and a yellow lens, before and after the exposure. Pain is measured in VAS-scale before, during and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
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
- Double (Participant, Outcomes Assessor)
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
- •superficial basal cell carcinomas on body area (clinically assessed to be mainly superficially growing and later on a biopsy proven sBCC or thin nBCC)
- •lesions accepted needs to be 10 cm apart from each other
排除标准
- •pigmented, morpheaform, infiltrative or nodular basal cell carcinomas
- •lesions that are in face and scalp area
- •pregnancy
- •breast feeding
- •allergy to photosensitizer
- •phorphyria or photosensitivity
研究组 & 干预措施
Hexylaminolevulinate cream
2% Hexylaminolevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream
干预措施: Hexylaminolevulinate cream (Drug)
Aminolevulinic Acid Nano Emulsion
78 mg/g Aminolevulinic Acid Nano Emulsion
干预措施: Aminolevulinic Acid Nano Emulsion (Drug)
Methylaminolevulinate cream
160 mg/g Methylaminolevulinate cream
干预措施: Methylaminolevulinate cream (Drug)
结局指标
主要结局
Histological lesion clearance
时间窗: 5 years
次要结局
- Detection of subclinical lesion with hyperspectral imaging system(5 years)