Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - A Phase 2 Randomized Double-blind Placebo Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 主要终点
- Histological cure
研究概览
简要总结
Brazil is a tropical country, with high incidence of ultraviolet radiation throughout the year. Many Europeans migrated to Brazil escaping either war or economic crisis to live in the country searching for opportunities. Low phototype combined with high incidence of UV light is a combination that not only affect the skin but also the lips. The current study was designed to use photodynamic therapy with metil 5-aminolevulinate for actinic cheilitis in a phase 2 clinical trial.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Clinical diagnosis with histopathological confirmation of actinic cheilitis
- •Patients will be requested to respect the timeframe of clinical consultations
- •No treatment for actinic cheilitis in the last 3 months
排除标准
- •Histopathological diagnosis of squamous cell carcinoma (SCC)
- •Patient presenting any type of immunosupression
- •Recurrent crust of the lip vermilion (high risk of SCC)
研究组 & 干预措施
Metil 5-aminolevulinate arm
Metil 5-aminolevulinate arm with photo activation.
干预措施: Metil 5-aminolevulinate (Drug)
Placebo arm
Placebo (without metil 5-aminolevulinate) arm with photo activation.
干预措施: Metil 5-aminolevulinate (Drug)
结局指标
主要结局
Histological cure
时间窗: 18 months
Expected histological cure in 40% of cases
Complete clinical response
时间窗: 18 months
Expected complete clinical response in 60% of cases
次要结局
- IHC analysis(18 months)
研究者
Daniel Cohen Goldenberg
Photodynamic therapy with methyl aminolevulinate in the treatment of actinic cheilitis
Instituto Nacional de Cancer, Brazil