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Dermatology

Safety and Efficacy of VP-102, a Proprietary, Drug-Device Combination Product Containing Cantharidin, 0.7% (w/v), in Children and Adults With Molluscum ContagiosumTwo Phase 3 Randomized Clinical Trials

Educational Objective
To determine the safety and efficacy of VP-102, a drug-device combination containing cantharidin, 0.7% (w/v), compared with vehicle in individuals with molluscum contagiosum.

1 Credit CME

JAMA Dermatology

Published Online: September 23, 2020

Original Investigation

Article Information and Disclosures

Lawrence F. Eichenfield, MD^1,2;

Wendy McFalda, MD³;

Bradford Brabec, MD⁴;

Elaine Siegfried, MD⁵;

Pearl Kwong, MD⁶;

Mark McBride, PhD⁷;

Jayson Rieger, PhD⁸;

Cynthia Willson, RN⁸;

Matthew Davidson, PhD⁸;

Patrick Burnett, MD, PhD⁸

Author Affiliations

¹School of Medicine, University of California, San Diego
²Department of Dermatology, Rady Children’s Hospital, San Diego, California
³Clarkston Skin Research, Clarkston, Michigan
⁴Midwest Children’s Health Research Institute, Lincoln, Nebraska
⁵Department of Pediatrics, St Louis University, St Louis, Missouri
⁶Solutions Through Advanced Research, Jacksonville, Florida
⁷Instat Consulting, Inc, Chatham, New Jersey
⁸Verrica Pharmaceuticals Inc, West Chester, Pennsylvania

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Key Points

Question What is the efficacy and safety of VP-102, a drug-device combination containing cantharidin, 0.7% (w/v), in individuals aged 2 years or older with molluscum contagiosum compared with vehicle?

Findings In 2 identical phase 3 trials (Cantharidin Application in Molluscum Patients [CAMP-1 and CAMP-2]) with a total of 582 participants, topical application of VP-102 or vehicle every 21 days for a maximum of 4 treatments resulted in complete lesion clearance rates of 46.3% (CAMP-1) and 54.0% (CAMP-2) with VP-102 vs 18% (CAMP-1) and 13% (CAMP-2) with the vehicle. The most common adverse events were primarily mild to moderate and included application site vesicles, pain, and pruritus.

Meaning The findings of these trials support the efficacy and safety of a proprietary cantharidin-based drug-device combination for treatment of molluscum contagiosum in children and adults.

Abstract

Importance Molluscum contagiosum (MC) is a common viral skin infection that primarily affects children. 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.

Objective To determine the safety and efficacy of VP-102, a drug-device combination containing cantharidin, 0.7% (w/v), compared with vehicle in individuals with MC.

Design, Setting, and Participants Two phase 3, randomized, double-blind, vehicle-controlled trials of identical design (Cantharidin Application in Molluscum Patients [CAMP-1 and CAMP-2]) were conducted in 31 centers across the US. A total of 528 individuals aged 2 years or older with MC participated. CAMP-1 was conducted from March 21 to November 26, 2018, and CAMP-2 was conducted from February 14 to September 26, 2018.

Interventions Participants were randomized (3:2) to topical application of VP-102 or vehicle to all treatable lesions every 21 days until complete lesion clearance or up to 4 treatments.

Main Outcomes and Measures The primary efficacy outcome was the proportion of VP-102–treated participants achieving complete clearance of all MC lesions (baseline and new) compared with those who received the vehicle at the end-of-study visit on day 84. Intent-to-treat analysis was conducted for the efficacy population. Secondary efficacy outcomes included the proportion of participants achieving complete clearance of lesions at days 21, 42, and 63. Safety outcomes included assessment of adverse events, including expected local skin reactions.

Results Of the 528 participants enrolled, 527 received treatment (CAMP-1, n = 265; CAMP-2, n = 262). A total of 267 of 527 participants (50.7%) were male; mean (SD) ages for CAMP-1 and CAMP-2 were 7.5 (5.3) years and 7.4 (8.0) years for the VP-102 groups and 6.3 (4.7) years and 7.3 (6.7) years for the vehicle groups. Treatment with VP-102 demonstrated superior efficacy to vehicle in the percentage of participants with complete clearance of MC lesions at the end of the study visit for CAMP-1 (VP-102: 46.3% vs vehicle: 17.9%; P < .001) and CAMP-2 (VP-102: 54.0% vs vehicle: 13.4%; P < .001). Adverse events were observed in 99% (CAMP-1) and 95% (CAMP-2) of VP-102–treated participants and 73% (CAMP-1) and 66% (CAMP-2) of vehicle-treated participants. The most common adverse events included application site vesicles, pain, pruritus, erythema, and scab. Most adverse events were mild or moderate in severity.

Conclusions and Relevance In the 2 phase 3 trials reported herein, VP-102 was statistically significantly superior to vehicle in achieving complete clearance of MC lesions at the end of the study visit in both trials, with adverse events that were generally mild to moderate and confined to application sites. 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.

Trial Registrations ClinicalTrials.gov Identifiers: NCT03377790 and NCT03377803

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Article Information

Accepted for Publication: July 2, 2020.

Published Online: September 23, 2020. doi:10.1001/jamadermatol.2020.3238

Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2020 Eichenfield LF et al. JAMA Dermatology.

Corresponding Author: Patrick Burnett, MD, PhD, Verrica Pharmaceuticals Inc, 10 N High St, West Chester, PA 19380 (MedInfo@verrica.com).

Author Contributions: Dr Burnett had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Eichenfield, Rieger, Willson, Davidson, Burnett.

Acquisition, analysis, or interpretation of data: Eichenfield, McFalda, Brabec, Siegfried, Kwong, McBride, Rieger, Willson, Burnett.

Drafting of the manuscript: Burnett.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: McBride, Rieger, Burnett.

Obtained funding: Rieger, Davidson.

Administrative, technical, or material support: Eichenfield, McFalda, Siegfried, Kwong, Rieger, Willson, Davidson, Burnett.

Supervision: Eichenfield, McFalda, Rieger, Willson, Davidson, Burnett.

Conflict of Interest Disclosures: Dr Eichenfield reported receiving grants from Verrica Pharmaceuticals Inc during the conduct of the study as well as personal fees and other support from Verrica Pharmaceuticals Inc outside the submitted work. Dr McFalda reported being a paid advisory board member for Paidion/Verrica Pharmaceuticals Inc during the conduct of the study. Dr Brabec reported receiving research site funding from Verrica Pharmaceuticals Inc during the conduct of the study. Dr Siegfried reported receiving research site funding paid to the institution from Verrica Pharmaceuticals Inc during the conduct of the study; personal fees from Verrica Pharmaceuticals Inc and Novan; personal fees, consultant fees, and research fees paid to the institution from Regeneron; consultant fees and research fees paid to the institution from Sanofi; consultant fees and research fees paid to the institution from Lilly; grant funding paid to the institution and fees for being on the data safety monitoring board from Pfizer; personal fees from Leo; research fees paid to the institution from Janssen; and research fees paid to the institution from Stiefel outside the submitted work. Dr Kwong reported receiving personal fees from Verrica Pharmaceuticals Inc during the conduct of the study; personal fees from Verrica Pharmaceuticals Inc outside the submitted work; and serving as a paid advisory board consultant for Verrica Pharmaceuticals Inc. Dr McBride reported receiving grants from Paidion Research Inc and grants from Verrica Pharmaceuticals Inc outside the submitted work and was paid, as a consultant, by the sponsor company for this study to run the analyses for this study and to perform quality control for the results. Dr Rieger reported being an employee of Verrica Pharmaceuticals Inc during the study, receiving company stock from Verrica Pharmaceuticals Inc, and having a patent to Verrica Pharmaceuticals Inc; he was also an employee of PBM Capital Group outside the submitted work; Ms Willson is an employee of Verrica Pharmaceuticals Inc and holds company stock. Dr Davidson reported personal fees and other support from Verrica Pharmaceuticals Inc during the conduct of the study and holds company stock; in addition, Dr Davidson had a patent to WO2018226894A1 pending, a patent to WO2018232277A1 pending, a patent to WO2016100732A3 pending, a patent to WO2016118633A1 pending, a patent to WO2015027111A1 pending, and patent number 2014308690 issued. Dr Burnett reported receiving personal fees from Verrica Pharmaceuticals Inc during the conduct of the study. No other disclosures were reported.

Funding/Support: Verrica Pharmaceuticals Inc provided funding and support for the trials and investigational agents (VP-102 and vehicle), as well as funding for the drafting of the manuscript and creation of the figures.

Role of the Funder/Sponsor: Verrica Pharmaceuticals Inc sponsored the design and conduct of the studies; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication.

Additional Contributions: We thank the participants, investigators, and site personnel who participated in the Cantharidin Application in Molluscum Patients trials and made them possible, as well as the members of the partner organizations (eAppendix in Supplement 2) who were critical to the conduct of the trial. Jessica McLin, PhD (Versant Learning Solutions), provided writing and graphic design assistance and was compensated for the work, and Melissa Olivadoti, PhD (Verrica Pharmaceutics Inc), contributed to technical editing and the management of author reviews; she did not receive compensation outside of salary.

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
1.00 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program;
1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
1.00 credit toward the CME [and Self-Assessment requirements] of the American Board of Surgery’s Continuous Certification program

It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.