efficacy and safety trial of topical resiquimod gel (0.06%) in patients with nodular basal cell carcinoma

Conditions: Nodular Basal Cell Carcinoma

Summary: the primary objective is the observation and description of the preliminary efficacy of resiquimod gel 0.06% on a single nodular basal cell carcinoma (nbcc) in a small group of patients.

efficacy assessments: * histopathological findings based on the biopsies of the primary tumor location and the tissue excision at the end of trial (histological cure). * description of the clinical-therapeutic effect of resiquimod on nbcc (nodular-basal cell carcinoma) by visual inspection (clinical evaluation of treatment area and assessment of complete clinical clearance) * rna-analysis (analysis of gene expressions for cytokines, cytotoxic and apoptotic signals) * investigator's global judgment of efficacy by means of a 7-point scale safety assessments: * evaluation of adverse events (aes) and serious adverse events (saes) * evaluation of local tolerability (local skin reactions as erythema, edema, erosion/ulceration, exsudate, dryness, encrustation) by means of symptom scoring scales (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe). * evaluation of systemic tolerability \[hematology (erythrocytes, leucocytes including neutrophils, hemoglobin, hematocrit, thrombocytes), blood chemistry (alkaline phosphatase, bilirubin, aspartate transaminase (asat), alanine transaminase (alat), serum creatinine), vital signs\]. the thresholds concerning laboratory abnormalities that determine patient's discontinuation from trial were predefined upfront. * evaluation of the number of patients withdrawn from the trial * investigator's global judgment of tolerability by means of a 6-point scale * photographic documentation of the treatment area exploratory parameter: * c-reactive protein (crp) * interferon-alpha, interleukin-6, interleukin-12, interferon-gamma, tnf-alpha (up-regulation of gene expression) * immunohistochemistry and characterization of cell types (cd8, t-cells, macrophages, dendritic cells) * in addition, blood serum samples will be preserved and frozen for later tests that will be specified to the patients. the preserved material will be stored for a maximum of 2 years.

Eligibility criteria:
inclusion criteria: * signed consent form. * male or non-pregnant, non-lactating female, ≥ 18 years. * must have a previously untreated, histologically confirmed nbcc on head, neck, trunk or arms. * nbcc must not be larger than 20 mm in diameter and must be less than 5 mm in depth. * willing and able to participate in the trial as an outpatient and comply with all trial requirements. exclusion criteria: * nbcc located close to or at mouth or eyes. * patients who have had an organ transplant. * known autoimmune disorder (especially psoriasis), impaired immune system (e.g. hiv), known thyroid abnormalities, known depression. * an open wound or an infection in treatment area. * dermatological disease or condition (e.g. rosacea, atopic dermatitis, eczema) in the treatment or surrounding area that might impair trial assessments. * evidence of an active infection or systemic cancer. * flu or flu-like symptoms (including general indisposition, fever, nausea, muscle pain, chills) within a week before start of the trial. * known allergy or hypersensitivity to any of the trial gel ingredients. * evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., renal or hepatic disease). * current alcohol abuse or chemical dependency as assessed by the investigator. * patient who is detained or committed to an institution by a law court or by legal authorities. * participation in another clinical trial within one month before start of the trial.