NCT01808950

Efficacy and Safety Trial of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma

Bi-center, Open Label, Non-comparative Trial Exploring Efficacy and Safety of Topical Resiquimod Gel (0.06%) in Patients With Nodular Basal Cell Carcinoma (nBCC)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Spirig Pharma Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 * Evaluation of the number of patients withdrawn from the trial * Investigator's global judgment of tolerability by means of a 6-point scale * Photographic documentation of the treatment area Exploratory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.

Conditions

• Nodular Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	0.06% Resiquimod Gel - A	single 60mg dose
DRUG	0.06% Resiquimod Gel - B	single 100mg dose
DRUG	0.06% Resiquimod Gel - C	shave biopsy of BCC followed by single 100mg dose

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-03-11
• Last updated: 2016-06-22
• Results posted: 2016-06-22

Locations

2 sites across 2 countries: Germany, Switzerland