Efficacy study, randomized, controlled, with CIGB-128-A injected perilesional in basal cell carcinoma in different treatment schedules

Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 150 人开始时间: 2013年2月1日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Factorial. Purpose: Treatment

•1. Clinical and histological diagnosis of BCC. 2. > 18 years of age. 3. Lesions between 1.5 cm2 - 10.0 cm2. 4. Lesions of any subtype, localization and size. 5. Non recurrent lesion. 6. Without previous specific treatments.

•1. Pregnancy, postpartum or breastfeeding women. 2. Hypersensitivity to interferon or other preparations used in the study. 3. Any uncompensated chronic disease corroborated by clinical examination. 4. Chronic cardiac, respiratory or arterial insufficiency reported by patients and verified by physical examination. 5. Antecedents of non-compensated transitory cerebral ischemia. 6. Medical non-treatable seizures. 7. Signs of medullar affectation. 8. Severe disorders of coagulation. 9. Sicklemia or drepanocityc anemia. 10. Severe hematological disorders, checked by complementary laboratory (hemoglobin <10 g/l in women and 11 g/l in men). 11. Diseases with metabolic involvement (liver diseases, kidney diseases, pancreatopatías, collagenopathies) reported by the patient and verified by clinical examination and laboratory (AST, ALT, alkaline phosphatase, bilirubin, creatinine, serum amylase). 12. General condition very committed (cachexia, severe debilitating disease patients). 13. Severe psychiatric disorders or other constraints that prevent the patient's consent or hinder evaluation.

发起方

Center for Genetic Engineering and Biotechnology (CIGB)