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).

• Authors: Lawrence F Eichenfield, Elaine Siegfried, Pearl Kwong, Mark McBride, Jayson Rieger, David Glover, Cynthia Willson, Matthew Davidson, Patrick Burnett, Melissa Olivadoti
• Journal: American journal of clinical dermatology (Am J Clin Dermatol) Vol. 22 Issue 2 Pg. 257-265 (Mar 2021) ISSN: 1179-1888 [Electronic] New Zealand
• PMID: 33599960 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Video-Audio Media)

Chemical References

• Irritants
• Cantharidin

Topics

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