VP-102, a drug-device combination containing cantharidin, 0.7% (w/v), was found to be safe and effective for treating molluscum contagiosum (MC) in two clinical trials.
“Cantharidin, a topical vesicant, has a long history of use for MC in compounded formulations, but the safety and efficacy of doses, regimens, and application methods have not been demonstrated in large-scale trials,” the researchers said. They conducted two phase 3 randomized, double-blind, vehicle-controlled trials (CAMP-1 and CAMP-2) at 31 centers across the United States to determine the safety and efficacy of VP-102. A total of 527 participants aged 2 years or older with MC were randomized 3:2 to topical application of VP-102 or vehicle every 21 days until complete lesion clearance or up to 4 treatments.
The researchers assessed the proportion of participants treated with VP-102 achieving complete clearance of all MC lesions compared with vehicle on day 84 as the primary efficacy outcome and conducted intent-to-treat analysis for the efficacy population. The proportion of participants achieving complete clearance of lesions at days 21, 42, and 63 were evaluated as secondary efficacy outcomes. They also monitored adverse events.
In the both trials, the researchers found VP-102 was superior in efficacy to vehicle. Overall, 46.3% and 54% of participants treated with VP-102 in CAMP-1 and CAMP-2, respectively, achieved complete clearance compared with 17.9% and 13.4% of participants treated with vehicle.
The most common adverse events included applicate site vesicles, pain, pruritus, erythema, and scab, most of which were mild or moderate in severity. These were observed in 99% and 95% of participants treated with VP-102 in CAMP-1 and CAMP-2, respectively, and 73% and 66% of participants treated with vehicle.
“These findings show that VP-102 is potentially an effective and safe treatment for MC, a common skin condition with no US Food and Drug Administration-approved treatments,” the researchers concluded.
Eichenfield LF, McFalda W, Brabec B, et al. Safety and efficacy of VP-102, a proprietary, drug-device combination product containing cantharidin, 0.7% (w/v), in children and adults with molluscum contagiosum: two phase 3 randomized clinical trials. JAMA Dermatol. Published online September 23, 2020. doi:10.1001/jamadermatol.2020.3238