Cantharidin Application in Molluscum Patients-1

NCT03377790 | Completed Phase 3 Results FDA Drug FDA Device

• 1 other identifier: VP-102-101
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 18

Brief Summary

This study is a Phase 3, randomized, double-blind, placebo-controlled, pivotal study to evaluate the safety and efficacy of VP-102 topical film-forming solution in subjects with Molluscum Contagiosum. VP-102 will be applied once every 21 days for up to 4 applications, to treatable molluscum contagiosum (molluscum) lesions on subjects 2 years and older. Efficacy will be assessed as the proportion of subjects achieving complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit.

Conditions

Molluscum Contagiosum

Keywords

Molluscum; Skin Diseases; Poxviridae Infections; Skin Diseases; Infectious; Skin Diseases; Viral; DNA Poxvirus

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS)

  Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS).

  Day 1 (Baseline and new) compared to Day 84 (EOS)

Secondary Outcomes (3)

• Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit

  Day 1 (Baseline and new) compared to Day 63

• Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit

  Day 1 (Baseline and new) compared to Day 42

• Proportion of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit

  Day 1 (Baseline and new) compared to Day 21

Other Outcomes (6)

• Change From Baseline to EOS Day 84 of the Composite Score From the Children's Dermatology Life Quality Index (CDLQI) Assessment at the EOS Visit to Measure the Quality of Life and Impact of Skin Disease in the Subset of Subjects 4 -16 Years of Age.

  Baseline to Day 84 (EOS)

• Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit

  Day 1 (Baseline) compared to Day 84 (EOS)

• Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.

  Day 1 (Baseline) compared to Day 84 (EOS)

Study Arms (2)

VP-102

ACTIVE COMPARATOR

VP-102 is contained within a single-use applicator. The VP-102 applicator consists of a plastic tube containing a sealed glass ampule and an applicator tip. One ampule contains 450 μL of VP-102 (0.7% \[w/v\] cantharidin) solution.

Combination Product: VP-102 - Cantharidin, Topical Film Forming Solution

Placebo

PLACEBO COMPARATOR

Placebo is contained within a single-use applicator. The placebo applicator consists of a plastic tube containing a sealed glass ampule and an applicator tip. One ampule contains 450μl of placebo solution with the same color and consistency as VP-102.

Combination Product: Placebo -Topical Film Forming Solution without VP-102

Interventions

VP-102 - Cantharidin, Topical Film Forming Solution COMBINATION_PRODUCT

VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Up to 4 applications of VP-102 will be administered to Molluscum lesions at 21-day intervals.

VP-102

Placebo -Topical Film Forming Solution without VP-102 COMBINATION_PRODUCT

Placebo a single-use drug device combination product containing only the vehicle. Up to 4 applications of Placebo will be administered to Molluscum lesions at 21-day intervals.

Placebo

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be healthy subjects, at least 2 years of age or older.
• Consent to having all molluscum lesions treated and the physician must be willing to treat all molluscum lesions initially present. Lesions within 10mm of the eyelid margins or the margin of any mucosal membrane should be evaluated carefully to ensure that they can be safely treated. Non-mucosal genital area lesions and inflamed lesions are considered treatable.
• Be otherwise medically healthy with no clinically significant medical history as determined by the investigator. Subjects exhibiting active Atopic Dermatitis may be enrolled.
• On day of treatment refrain from application of all topical agents including alcohol-based sanitary products and sunscreens for a minimum of 4 hours before Study drug application. Topical agents including alcohol-based sanitary products and sunscreens may be used after application of the study drug so long as they are not applied within 5cm of treated skin lesions.
• Refrain from swimming, bathing or prolonged immersion in water or any liquids until the Study drug is removed.
• Have the ability or have a guardian with the ability to follow study instructions and be likely to complete all study requirements.
• Provide written informed consent or assent in a manner approved by the institutional review board (IRB) and/or have a parent/guardian provide written informed consent as evidenced by the signature on an IRB approved assent/consent form.
• Provide written authorization for use and disclosure of protected health information.
• Agree to allow photographs to be taken, (selected sites only) of selected lesions at every visit that will be used for training, publication and future marketing brochures.

You may not qualify if:

• Subjects will be excluded from the study if they:
• Are unable to cooperate with the requirements or visits of the study, as determined by the investigator.
• Are systemically immunosuppressed or are receiving treatments such as chemotherapy or other non-topical immunosuppressive agents.
• Have any lesions present at baseline in anatomic locations that the subject/parent/guardian or the physician is unwilling to treat.
• Have had any previous treatment of molluscum including the use of cantharidin, antivirals, retinoids, curettage or freezing of lesions in the past 14 days. Additional treatments should not be implemented during the course of the study.
• Have a history of illness or any dermatologic disorder which, in the opinion of the investigator, will interfere with accurate counting of lesions or increase the risk of adverse events.
• History or presence of clinically significant medical, psychiatric, or emotional condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data.
• Have a history or presence of hypersensitivity or an idiosyncratic reaction to the Study drug or related compounds, or drug product excipients (acetone, ethyl alcohol, nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and denatonium benzoate).
• Have a condition or situation that may interfere significantly with the subject's participation in the study (e.g., subjects who required hospitalization in the 2 months prior to screening for an acute or chronic condition including alcohol or drug abuse), at the discretion of the investigator.
• Have received another investigational product within 14 days prior to the first application of the Study drug.
• Have been treated within 14 days with a product that contains cantharidin (topical or homeopathic preparations) for any reason prior to screening.
• Are sexually active or may become sexually active and are unwilling to practice responsible birth control methods. (e.g., combination of condoms and foam, birth control pills, intrauterine device, patch, shot and vaginal ring, etc.). Withdrawal is not an acceptable method of birth control. Females that have reached menarche must have a negative urine pregnancy test at each visit prior to treatment with Study drug.
• Are pregnant or breastfeeding.

Sponsors & Collaborators

• Verrica Pharmaceuticals Inc.: lead
• Instat Consulting, Inc.: collaborator
• Paidion Research, Inc.: collaborator
• Database Integrations, Inc.: collaborator

Study Sites (18)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35205, United States

Location

Southeastern Pediatric Associates

Dothan, Alabama, 36305, United States

Location

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

Study Protocol, Inc.,

Boynton Beach, Florida, 33437, United States

Location

Skin Research Institute

Coral Gables, Florida, 33146, United States

Location

ASCLEPES Research Center

Spring Hill, Florida, 34609, United States

Location

Olympian Clinical Research

Tampa, Florida, 33609, United States

Location

Summit Dermatology

Oakbrook Terrace, Illinois, 60181, United States

Location

Clarkston Skin Research

Clarkston, Michigan, 48346, United States

Location

St Louis Children's Hospital

St Louis, Missouri, 63104, United States

Location

Midwest Children's Hospital

Lincoln, Nebraska, 68522, United States

Location

Kings County Hospital

Brooklyn, New York, 11203, United States

Location

University North Carolina Dermatology Center

Chapel Hill, North Carolina, 27516, United States

Location

The Pediatric Associates of Fairfield, Inc

Fairfield, Ohio, 45014, United States

Location

Holston Medical Group

Bristol, Tennessee, 37620, United States

Location

Arlington Research Center

Arlington, Texas, 66011, United States

Location

Center for Skin Research

Houston, Texas, 77056, United States

Location

ACRC Trials Plano Pediatrics

Plano, Texas, 75093, United States

Location

Related Publications (3)

• Eichenfield LF, Kwong P, Gonzalez ME, Yan A, D'Arnaud P, Burnett P, Olivadoti M. Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in Molluscum Contagiosum by Body Region: Post hoc Pooled Analyses from Two Phase III Randomized Trials. J Clin Aesthet Dermatol. 2021 Oct;14(10):42-47.

  PMID: 34976290 DERIVED

• Eichenfield LF, Siegfried E, Kwong P, McBride M, Rieger J, Glover D, Willson C, Davidson M, Burnett P, Olivadoti M. 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.

  PMID: 33599960 DERIVED

• Eichenfield LF, McFalda W, Brabec B, Siegfried E, Kwong P, McBride M, Rieger J, Willson C, Davidson M, Burnett P. Safety and Efficacy of VP-102, a Proprietary, Drug-Device Combination Product Containing Cantharidin, 0.7% (w/v), in Children and Adults With Molluscum Contagiosum: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Dec 1;156(12):1315-1323. doi: 10.1001/jamadermatol.2020.3238.

  PMID: 32965495 DERIVED

MeSH Terms

Conditions

Molluscum Contagiosum; Skin Diseases; Poxviridae Infections; Cellulitis; Skin Diseases, Viral

Interventions

VP-102

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Infectious; Skin and Connective Tissue Diseases; Suppuration; Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Susan Cutler, VP, Medical Affairs
• Organization: Verrica Pharmaceuticals

scutler@verrica.com

484-773-0898

Study Officials

• Lawrence Eichenfield, MD

  Rady Children's Hospital; San Diego, California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 19, 2017
• Study Start: March 21, 2018
• Primary Completion: November 26, 2018
• Study Completion: November 26, 2018
• Last Updated: January 11, 2022
• Results First Posted: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)