Skin basal cell carcinoma (BCC)
Conditions
Interventions
Intralesional treatment
three times per week for 3 weeks. After this time the patients that do not have complete response, will be receive it once a week until the response is achieved or they complete 11 weeks of treatment,
Interferon-alpha
Placebos
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Ministry of Public Health, CUBA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age equal or superior to 18 years. Informed consent given by the patient. Patients with clinical and histological diagnosis of B.C.C. Lesions of any clinical variant, location and color of the skin. Size of the lesion from 1 to 4 cm. No recurrent or recurrent previously treated disease.
Exclusion criteria
Exclusion criteria: Pregnant or lactating women. A history of hypersensitivity to interferon or any excipient in the study treatment. Acute or chronic hepatic disease (AST and ALT > 2 times upper limit of normal and/or serum total bilirubin >17 _mol/L). Acute or chronic renal disease. Uncompensated heart insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response (complete response, partial response, stable disease, progression). Time of measurement: 12 weeks of having started the treatment. Histological Response (cured or done not cure). Time of measurement: 12 weeks of having started the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of response (months). Time of measurement: weekly for 12 weeks. Cosmetic results (good, regular, bad). Time of measurement: every three months for 2 years. Proportion of patients that have adverse reactions (percentage). Time of measurement: 2 years. Time until the relapse (months). Time of measurement: 2 years. | — |
Countries
Cuba
Contacts
Public ContactYanelda García-Vega
Center for Genetic Engineering and Biotechnology.(CIGB).
Outcome results
None listed