Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT01808950
Brief 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.
Detailed Description:
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* Evaluation of the number of patients withdrawn from the trial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.
Study:
NCT01808950
Study Brief:
Protocol Section:
NCT01808950