Conventional Versus Fractional CO2 Laser Assisted Photodynamic Therapy for Basal Call Carcinomas and Actinic Keratoses
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Treatment response
研究概览
简要总结
Nodular Basal Cell Carcinomas:
Compare the efficacy and safety of conventional versus fractional laser assisted PDT for difficult to treat nodular cell carcinomas in the face.
Actinic keratosis:
Compare the efficacy and safety of conventional versus fractional laser assisted PDT for moderate to severe actinic keratoses located in the face and on the hands.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Skin type I-III
- •Fertile women using secure birth control
- •Moderate to severe actinic keratoses in the face or on the hands,
- •Difficult to treat nodular basal cell carcinomas in the face
排除标准
- •Pregnancy or breast feeding patients
- •Patients with porphyria
- •Patients with Gorlins syndrome
- •Patients with a tendency to produce hypertrophic scars or keloids
- •Patients with known allergy to Metvix
- •Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic, dementia, mentally ill etc.)
- •Patients with pigmented or morphea basal cell carcinomas
- •Know herpes simplex virus infection in treatment areas
研究组 & 干预措施
AK split-face treatment
Split-face treatment of two symmetrical areas with moderate to severe actinic keratoses. One area is treated with conventional PDT the other with fractional laser assisted PDT.
干预措施: Conventional photodynamic therapy (Drug)
AK split-face treatment
Split-face treatment of two symmetrical areas with moderate to severe actinic keratoses. One area is treated with conventional PDT the other with fractional laser assisted PDT.
干预措施: Fractional CO2 laser assisted PDT (Drug)
Fractional laser assisted PDT for BCC
Difficult to treat nodular basal cell carcinomas in the face is pretreated with fractional CO2 laser followed by methyl-aminolevulinate PDT.
干预措施: Fractional CO2 laser assisted PDT (Drug)
Konventional PDT for BCC
Difficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT.
干预措施: Conventional photodynamic therapy (Drug)
结局指标
主要结局
Treatment response
时间窗: 12 months
Blinded histological examination from patients with basal cell carcinomas
Reoccurrence
时间窗: 12 months
Clinical evaluation by a blinded physician
次要结局
- Pain(during laser and PDT)
- Adverse effects(12 months)
- Fluorescence(3 hours)
- Cosmetic result(12 months)