Pooled Results of Two Randomized Phase III Trials Evaluating VP-102, a Drug-Device Combination Product Containing Cantharidin 0.7% (w/v) for the Treatment of Molluscum Contagiosum

Abstract

Background: Compounded cantharidin has been used for decades to treat molluscum contagiosum but lacks rigorous clinical evidence to support its safety and efficacy. VP-102 is a shelf-stable drug-device combination product that contains topical cantharidin (0.7% weight/volume [w/v]) and is being evaluated for the treatment of molluscum.

Objectives: Our objective was to present pooled safety and efficacy analyses of VP-102 in the treatment of molluscum compared with vehicle.

Methods: Participants aged ≥ 2 years were randomized 3:2 to topical administration of VP-102 or vehicle in two randomized, double-blind, vehicle-controlled phase III trials. Study drug was applied to all baseline and new lesions once every 21 days until clear or for a maximum of four applications. Assessors blinded to treatment counted all lesions at each study visit. All adverse events (AEs) were documented. Data were pooled for analyses.

Results: In total, 310 participants received VP-102 and 218 received vehicle. Mean age was 7.5 years (range 2-60) for VP-102 and 6.8 (2-54) for vehicle. Complete clearance of all molluscum lesions at day 84 occurred in 50% of VP-102 participants and 15.6% of vehicle recipients (p < 0.0001). Mean molluscum lesion counts decreased 76% for VP-102 and 0.3% for vehicle at day 84 (p < 0.0001). The most common AEs in the VP-102 group were application site blistering, pruritus, pain, and erythema, which were generally mild or moderate in severity.

Conclusions: Pooled analyses showed a significantly higher percentage of participants with complete molluscum lesion clearance and larger reductions in lesion counts with VP-102 than with vehicle. AEs were anticipated because of the pharmacodynamic properties of cantharidin.

Trial registration: ClinicalTrials.gov identifiers: NCT03377790 (first posted 19 December 2017) and NCT03377803 (first posted 19 December 2017). Video abstract: Pooled Results of Two Randomized Phase III Trials Evaluating VP 102, a Drug Device Combination Product Containing Cantharidin 0.7% (w/v) for the Treatment of Molluscum Contagiosum (MP4 131293 KB).

Conflict of interest statement

Lawrence F. Eichenfield, MD, received funds for research to his institution as a study center and consulting fees and stock options from Verrica Pharmaceuticals Inc. He is also on the board of directors for Verrica Pharmaceuticals Inc. Elaine Siegfried, MD, received funds for research to her institution as a study center and consulting fees from Verrica Pharmaceuticals Inc. She has also received consulting fees and funds as a research center for Novan. Pearl Kwong, MD, received funds for research as a study center and consulting fees from Verrica Pharmaceuticals Inc. Mark McBride, PhD, was paid as a consultant to run analyses on the statistics for the study by Verrica Pharmaceuticals Inc. Dr. McBride is also a consultant for Novan. Jayson Rieger, PhD, was an employee of Verrica Pharmaceuticals, holds company stock from Verrica Pharmaceuticals Inc., and holds a patent related to the work. David Glover, PhD, is an employee of PBM Capital Group. Cynthia Willson, RN, BSN, is an employee of Verrica Pharmaceuticals and holds company stock. Matthew Davidson, PhD, was an employee of, received personal fees from, and holds stock of Verrica Pharmaceuticals Inc. He also holds patents related to the research. Patrick Burnett, MD, PhD, was an employee of Verrica Pharmaceuticals and holds company stock. Melissa Olivadoti, PhD, is an employee of Verrica Pharmaceuticals.

Figures

Fig. 1

Percentage of participants with complete clearance of baseline and new molluscum lesions (CAMP-1 and CAMP-2). Intent-to-treat population; VP-102-treated participants (n = 310) and vehicle-treated participants (n = 218). The percentage of participants with complete clearance was statistically significantly higher in the VP-102-treated participants starting after the first treatment (visit 2/day 21) and persisted through the end of the study (EOS visit/day 84). Participants who achieved complete clearance at earlier visits were required to be clear at the EOS visit/day 84 to be counted as achieving clearance at that visit

Fig. 2

Percentage change from baseline in molluscum lesion counts after treatment with VP-102 or vehicle (CAMP-1 and CAMP-2). Intent-to-treat population; VP-102-treated participants (n = 310) and vehicle-treated participants (n = 218). VP-102-treated participants had a statistically significantly larger decrease in mean percentage change in lesions from baseline visit compared with vehicle-treated participants at each visit beginning after the first treatment through the EOS visit (day 84). Overall, VP-102-treated participants had a 76% decrease in lesions whereas vehicle-treated participants had a decrease of 0.3%. EOS end of study. *p < 0.0001