Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Clinical Response to Photodynamic Therapy
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.
详细描述
Background and Aim: Basal cell carcinoma (BCC) is the most common skin cancer .Photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. This study was designed with the aim of the evaluation of efficacy of PDT in treatment of BCC and factors that may affect response rate.
Materials and Methods
This was a clinical trial which was done on 28 BCCs. Patients were treated with ALA-PDT monthly for 1-6 sessions and evaluated for clinical response,cosmetic results and probable side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Histologically proven BCCs
排除标准
- •rodent ulcer
- •morphea type
- •history of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month
- •pregnancy
- •breast feeding
- •history of another therapeutic intervention for bcc during last 6 months
结局指标
主要结局
Clinical Response to Photodynamic Therapy
时间窗: immediately after termination of treatment course (with an average of 5 month after initiation of PDT)
categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced
次要结局
- Histologic Resolution of Lesion(immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT))