Evidence map›Paper›PMID 33599960›Full record

Trial reportAmerican journal of clinical dermatology2021

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.

Lawrence F Eichenfield, Elaine Siegfried, Pearl Kwong, Mark McBride, Jayson Rieger, David Glover, Cynthia Willson, Matthew Davidson, Patrick Burnett, Melissa Olivadoti

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of clinical dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03377790 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Study to Evaluate the Safety and Efficacy of VP-102 Topical Film-Forming Solution [0.7% (w/v) Cantharidin] in Subjects (2 Years and Older) With Molluscum Contagiosum

TypeinterventionalSponsorVerrica Pharmaceuticals Inc.Ran2018 to 2018Enrolled266ConditionsMolluscum ContagiosumArmsVP-102 - Cantharidin, Topical Film Forming Solution, Placebo -Topical Film Forming Solution without VP-102
NCT03377803 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Pivotal Study to Evaluate the Safety and Efficacy of VP-102 Topical Film-Forming Solution [0.7% (w/v) Cantharidin] in Subjects (2 Years and Older) With Molluscum Contagiosum

TypeinterventionalSponsorVerrica Pharmaceuticals Inc.Ran2018 to 2018Enrolled262ConditionsMolluscum ContagiosumArmsVP-102 - Cantharidin, Topical Film Forming Solution, Placebo -Topical Film Forming Solution without VP-102
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 2 countries.

Lawrence F EichenfieldDepartment of Dermatology, University of California San Diego School of Medicine, Rady Children's Hospital, San Diego, CA, USA.ORCID http://orcid.org/0000-0002-2760-0474
Elaine SiegfriedSt. Louis University School of Medicine, St. Louis, MO, USA.ORCID http://orcid.org/0000-0002-4794-9905
Pearl KwongSolutions Through Advanced Research, Jacksonville, FL, USA.ORCID http://orcid.org/0000-0002-3121-420X
Mark McBrideInstat Consulting, Inc., Chatham, NJ, USA.
Jayson RiegerVerrica Pharmaceuticals Inc., West Chester, PA, USA.
David GloverVerrica Pharmaceuticals Inc., West Chester, PA, USA.
Cynthia WillsonVerrica Pharmaceuticals Inc., West Chester, PA, USA.
Matthew DavidsonVerrica Pharmaceuticals Inc., West Chester, PA, USA.
Patrick BurnettVerrica Pharmaceuticals Inc., West Chester, PA, USA.
Melissa OlivadotiVerrica Pharmaceuticals Inc., West Chester, PA, USA. molivadoti@verrica.com.ORCID http://orcid.org/0000-0003-3692-5278
Ospedale Versilia · ITSaint Louis University · USUniversity of California San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCompounded 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.

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

methodsParticipants 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.

resultsIn 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.

conclusionsPooled 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 registrationClinicalTrials.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).

Indexed as

Equipment DesignAdministration, CutaneousAdolescentCantharidinChildChild, PreschoolDouble-Blind MethodErythemaHumansIrritantsMaleMolluscum ContagiosumPainPruritusSeverity of Illness IndexTreatment OutcomeCantharidinIrritants

Identifiers

PMID33599960
PMCPMC7973914
OpenAlexW3133446317

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.