ABSTRACT
OBJECTIVES: This study aimed to evaluate the efficacy and safety of cashew nut extract (DeBCC©) cream compared with a vehicle cream in the treatment of basal cell carcinomas (BCC), mainly by comparing each group's composite clearance rate, defined by the absence of histopathologic evidence of BCC at the target lesion site. METHODS: A randomized double-blind vehicle-controlled trial was conducted on nineteen patients, who underwent eight weekly topical treatment application sessions of either vehicle or experimental drug. Six weeks post-treatment, they underwent surgical excision of their lesions. A dermatopathologist examined these specimens. Clinical and histopathologic clearances were evaluated. RESULTS: The clinical clearance rate (67%) of DeBCC was significantly higher compared to vehicle (p=0.003), while the composite clearance rate (33%) was not (p>0.005). The pre-test probability of clinical clearance in concordance with histopathologic clearance (15.79%) suggests that clinical resolution of a BCC lesion may not equate to histopathologic clerance. CONCLUSION: This study showed a modest clinical clerance rate but a low composite clerance rate for DeBCC cream. Further studies with bigger sample size that are limited to less aggressive BCC subtypes are needed to strongly establish the efficacy and safety of topical cashew nut extract for BCC treatment.