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Background: Basal cell carcinoma (BCC) is the most commonly diagnosed skin cancer, with increasing incidence each year. Although the treatment of BCC is typically surgical, a non-surgical approach is highly desirable for patients with non-aggressive BCC recurrence, multiple tumors, poor general health, or with lesions in vulnerable areas. In the last few years, advanced cancer treatment options have targeted the Hedgehog pathway, known to regulate the proliferation of cancer stem cells and increase tumor invasiveness. Preliminary studies show that posaconazole may present a safer clinical alternative than current methods in the management of BCC. Therefore, this study aims to analyze the efficacy of posaconazole as a safe therapeutic option for nodular BCC lesions. Proven efficacy may have a significant impact on public health, as well as the substantially reduced medical and economic burden resulting from this disease prevalence.
Methods: This study is designed as a single center, randomized, double-blinded, placebo controlled trial. Before undergoing surgical excision, 170 patients (1:1 allocation) will be randomized to receive 800 mg daily of posaconazole or placebo for four weeks.
Discussion: The main strengths of this study are the potential to increase general understanding of the therapeutic and metabolic impact of posaconazole. The results from this trial may also provide valuable insights to guide a larger clinical trial of posaconazole for inoperable BCC. The main limitations of the study consist of the limited intervention time frame of 4 weeks and the sample representativeness since it is a single-center study of patients with nodular BCC.