Topical Green Tea Ointment in Treatment of Superficial Skin Cancer
关键词
抽象
日期
最后验证: | 05/31/2015 |
首次提交: | 12/17/2013 |
提交的预估入学人数: | 01/05/2014 |
首次发布: | 01/06/2014 |
上次提交的更新: | 05/16/2016 |
最近更新发布: | 05/17/2016 |
实际学习开始日期: | 10/31/2014 |
预计主要完成日期: | 08/31/2015 |
预计完成日期: | 01/31/2016 |
状况或疾病
干预/治疗
Drug: Sinecatechins 10%
Drug: Placebo
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Sinecatechins 10% Patients are instructed to apply a thin layer of the sinecatechins 10% ointment twice daily (morning and evening) in a thin layer to the tumour including 5mm of the surrounding skin. Before applying a new layer patients are advised to wipe off the remnants. Sinecatechins 10% ointment has to be applied for six weeks. Patients are advised to wash their hands after each application to prevent spreading of the ointment. | Drug: Sinecatechins 10% |
Placebo Comparator: Placebo Patients are instructed to apply a thin layer of the placebo ointment twice daily (morning and evening) in a thin layer to the tumour including 5mm of the surrounding skin. Before applying a new layer patients are advised to wipe off the remnants. Sinecatechins 10% ointment has to be applied for six weeks. Patients are advised to wash their hands after each application to prevent spreading of the ointment. | Drug: Placebo Composition, apart from the active substance, is otherwise identical to the investigational medical product. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Adults aged 18 years or older - Primary histological proven superficial basal cell carcinoma ≥ 4mm and ≤ 20mm - Comorbidities may not interfere with study treatment (evaluated by investigator) - Capable to understand instructions Exclusion Criteria: - Recurrent sBCC (previous treatment) - Breast-feeding or pregnant women - Serious comorbidities - Use of immunosuppressive medication during the trial period or within 30 days before enrolment - Patients with genetic skin cancer disorders - Tumour located in the H zone (high-risk area of face) or scalp |
结果
主要结果指标
1. Percentage of patients with complete histological clearance [After 6 weeks treatment]
次要成果指标
1. Number of applications actually done by the patient divided by the total prescribed number of applications. [Week 6]
2. Number of local skin reactions, adverse events and serious adverse events [Up to 3 weeks]