Guenthner S, McFalda W, Tate M, et al. - The adverse event profile and effectiveness of VP-102, a drug-device combination product containing cantharidin (0.7% w/v) in a single-use shelf-stable applicator, under occlusion evidenced in this investigation support the conclusion that a 6-h or up to 24-h exposure regimen serves an acceptable risk-benefit profile, justifying the conduct of a larger vehicle-controlled phase III study in external genital warts.

• The research was divided into two parts.

• Part A was for dose determination, while Part B was for safety and efficacy evaluation after Part A was completed.

• Pooled results from Parts B and A of the 6-h and 24-h VP-102 treatment regimens revealed that 36.7% and 33.3% of participants, respectively, achieved complete clearance of all treatable external genital warts at the end of treatment, compared with 4.2% and 0% with the vehicle.

• Adverse effects experienced by VP-102-treated individuals were mild to moderate in severity, consistent with the pharmacologic activity of cantharidin as a vesicant.

• Application-site vesicles, pain, and erythema were the most prevalent side effects.

• There were no dropouts from the study due to adverse events, and no significant adverse events were attributed to the treatment.