Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma With 6 Months Follow-up
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of photodynamic therapy (PDT)in treatment of Basal cell carcinoma (BCC) and recurrence rate after 6 months.
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 recurrence rate after 6 months .
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,recurrence rate 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
研究组 & 干预措施
BCC, ALA-PDT
Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT
干预措施: photodynamic therapy (Radiation)
结局指标
主要结局
response rate at the end of therapy protocol (regarding tumor diameter and/or pathologic examination)
时间窗: 1 year
次要结局
- recurrence rate(regarding clinical and/or pathological examination) after 6 months of follow up(1 year)