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

Am J Clin Dermatol. 2021 Mar;22(2):257-265. doi: 10.1007/s40257-020-00570-8. Epub 2021 Feb 18.


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).

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Video-Audio Media

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Cantharidin / administration & dosage*
  • Cantharidin / adverse effects
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Equipment Design*
  • Erythema / chemically induced
  • Erythema / diagnosis
  • Erythema / prevention & control
  • Humans
  • Irritants / administration & dosage*
  • Irritants / adverse effects
  • Male
  • Molluscum Contagiosum / drug therapy*
  • Pain / chemically induced
  • Pain / diagnosis
  • Pain / prevention & control
  • Pruritus / chemically induced
  • Pruritus / diagnosis
  • Pruritus / prevention & control
  • Severity of Illness Index
  • Treatment Outcome
  • Young Adult


  • Irritants
  • Cantharidin

Associated data

  • ClinicalTrials.gov/NCT03377803
  • ClinicalTrials.gov/NCT03377790