Cantharidin Application in Molluscum Patients-1

Phase 3

Completed

• Conditions: Molluscum Contagiosum
• Interventions: Combination Product: VP-102 - Cantharidin, Topical Film Forming Solution; Combination Product: Placebo -Topical Film Forming Solution without VP-102

• Registration Number: NCT03377790
• Lead Sponsor: Verrica Pharmaceuticals Inc.

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.

Detailed Description

This is a Phase 3, multi-center, randomized, double-blind, placebo (vehicle)-controlled, pivotal study that will be conducted in the United States to determine the efficacy and safety of VP-102 following treatment of molluscum lesions for up to 4 treatments, every 21 days, with VP-102/placebo in 250 subjects. Subjects will receive active VP-102 or placebo in a 3:2 ratio. Study drug (VP-102 or placebo) will be supplied in single-use applicators.

The film-forming Study drug solution will be applied and left on the lesions for 24 hours before the subject and/or parents/guardian washes the lesions. Study drug may be removed prior to the 24-hour time point in the event treatment-emergent AEs are experienced.

Molluscum lesions will be treated without occlusion in all anatomic areas including the face, trunk, back, arms, legs, hands, feet, anogenital region and buttocks.

Study Timeline

• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-19
• Study Start: 2018-03-21
• Primary Completion: 2018-11-26
• Study Completion: 2018-11-26
• Disposition First Submitted: 2020-05-28
• Results First Submitted: 2021-10-12
• Results First Submitted QC: 2021-11-15
• Disposition First Submitted QC: 2021-11-15
• Status Verified: 2021-12
• Results First Posted: 2021-12-14
• Disposition First Posted: 2021-12-14
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

To qualify for inclusion in this study, subjects must:

1. Be healthy subjects, at least 2 years of age or older.
2. 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.
3. Be otherwise medically healthy with no clinically significant medical history as determined by the investigator. Subjects exhibiting active Atopic Dermatitis may be enrolled.
4. 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.
5. Refrain from swimming, bathing or prolonged immersion in water or any liquids until the Study drug is removed.
6. Have the ability or have a guardian with the ability to follow study instructions and be likely to complete all study requirements.
7. 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.
8. Provide written authorization for use and disclosure of protected health information.
9. 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.

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Exclusion Criteria

Subjects will be excluded from the study if they:

1. Are unable to cooperate with the requirements or visits of the study, as determined by the investigator.
2. Are systemically immunosuppressed or are receiving treatments such as chemotherapy or other non-topical immunosuppressive agents.
3. Have any lesions present at baseline in anatomic locations that the subject/parent/guardian or the physician is unwilling to treat.
4. 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.
5. 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.
6. 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.
7. 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).
8. 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.
9. Have received another investigational product within 14 days prior to the first application of the Study drug.
10. Have been treated within 14 days with a product that contains cantharidin (topical or homeopathic preparations) for any reason prior to screening.
11. 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.
12. Are pregnant or breastfeeding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VP-102	VP-102 - Cantharidin, Topical Film Forming Solution	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.
Placebo	Placebo -Topical Film Forming Solution without VP-102	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit.
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 63 visit.
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	Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 42 visit.

Trial Locations

Locations (18)

Study Protocol, Inc.,; 🇺🇸 Boynton Beach, Florida, United States

Summit Dermatology; 🇺🇸 Oakbrook Terrace, Illinois, United States

The Pediatric Associates of Fairfield, Inc; 🇺🇸 Fairfield, Ohio, United States

ACRC Trials Plano Pediatrics; 🇺🇸 Plano, Texas, United States

ASCLEPES Research Center; 🇺🇸 Spring Hill, Florida, United States

Midwest Children's Hospital; 🇺🇸 Lincoln, Nebraska, United States

Kings County Hospital; 🇺🇸 Brooklyn, New York, United States

Olympian Clinical Research; 🇺🇸 Tampa, Florida, United States

Clarkston Skin Research; 🇺🇸 Clarkston, Michigan, United States

University North Carolina Dermatology Center; 🇺🇸 Chapel Hill, North Carolina, United States

Arlington Research Center; 🇺🇸 Arlington, Texas, United States

Skin Research Institute; 🇺🇸 Coral Gables, Florida, United States

St Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States

Holston Medical Group; 🇺🇸 Bristol, Tennessee, United States

Center for Skin Research; 🇺🇸 Houston, Texas, United States

Alabama Clinical Therapeutics; 🇺🇸 Birmingham, Alabama, United States

Southeastern Pediatric Associates; 🇺🇸 Dothan, Alabama, United States

Applied Research Center of Arkansas; 🇺🇸 Little Rock, Arkansas, United States