Topical Green Tea Ointment in Treatment of Superficial Skin Cancer
Palabras clave
Abstracto
fechas
Verificado por última vez: | 05/31/2015 |
Primero enviado: | 12/17/2013 |
Inscripción estimada enviada: | 01/05/2014 |
Publicado por primera vez: | 01/06/2014 |
Última actualización enviada: | 05/16/2016 |
Última actualización publicada: | 05/17/2016 |
Fecha de inicio real del estudio: | 10/31/2014 |
Fecha estimada de finalización primaria: | 08/31/2015 |
Fecha estimada de finalización del estudio: | 01/31/2016 |
Condición o enfermedad
Intervención / tratamiento
Drug: Sinecatechins 10%
Drug: Placebo
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
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. |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | 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 |
Salir
Medidas de resultado primarias
1. Percentage of patients with complete histological clearance [After 6 weeks treatment]
Medidas de resultado secundarias
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]