InCarbacel-II

Phase 2

• Conditions: Skin basal cell carcinoma (BCC); Carcinoma, Basal Cell; Skin Neoplasms; Neoplasms, Basal Cell; Neoplasms, Glandular and Epithelial; Carcinoma; Skin Diseases

• Registration Number: RPCEC00000066
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.