Cantharidin Application in Molluscum Patients (CAMP-2)

• Sponsor: Verrica Pharmaceuticals Inc.
• Collaborators: Instat Consulting, Inc.; Paidion Research, Inc.; Database Integrations, Inc.
• Information provided by (Responsible Party): Verrica Pharmaceuticals Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Molluscum Contagiosum	Drug: VP-102; Drug: Placebo; Device: Applicator	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	262 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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
Actual Study Start Date :	February 14, 2018
Estimated Primary Completion Date :	September 28, 2018
Estimated Study Completion Date :	September 28, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: VP-102; VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days	Drug: VP-102; VP-102 Active will be administered via the applicator to Molluscum lesions; Other Name: Topical Film Forming Solution; Device: Applicator; Used to apply the topical film forming Active or Placebo to Molluscum.; Other Name: For use in applying VP-102 Drug or Placebo Vehicle
Placebo Comparator: Placebo; Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days	Drug: Placebo; Placebo to be applied via the applicator to Molluscum lesions; Other Name: Vehicle Control Topical Film Forming Solution without VP-102; Device: Applicator; Used to apply the topical film forming Active or Placebo to Molluscum.; Other Name: For use in applying VP-102 Drug or Placebo Vehicle

Outcome Measures

Primary Outcome Measures :

1. Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS). [ Time Frame: Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) visit. ]

Secondary Outcome Measures :

1. Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 63 visit. [ Time Frame: Treatment Visit Day 1 (Baseline) compared to Day 63 Treatment Visit. ]
2. Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 42 visit. [ Time Frame: Treatment Visit Day 1 (Baseline) compared to Day 42 Treatment Visit. ]
3. Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit. [ Time Frame: Treatment Visit Day 1 (Baseline) compared to Day 21 Treatment Visit. ]

Other Outcome Measures:

1. Change from baseline 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. [ Time Frame: Measured at each Treatment Visit Day 1 (Baseline), 21, 42, 63 and Day 84 (EOS) visit. ]
2. Percent reduction of all treatable molluscum lesions (baseline and new) from baseline at the EOS visit. [ Time Frame: Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) visit. ]
3. Change from baseline in the number of treatable molluscum lesions (baseline and new) at the EOS visit. [ Time Frame: Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) visit. ]
4. Proportion of subjects exhibiting a 75% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit. [ Time Frame: Treatment Visit Day 1 (Baseline) compared to Day 84(EOS) visit. ]
5. Proportion of subjects exhibiting a 90% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit. [ Time Frame: Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) visit. ]
6. Subject reported spread to household members as measured by any new occurrence of molluscum in household members of subject. [ Time Frame: Evaluated at Treatment Visit Days 1, 21, 42, 63 and 84(EOS). ]

Eligibility Criteria

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Ages Eligible for Study:	2 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

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.

Contacts and Locations

Locations

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United States, California
Bakersfield Dermatology
Bakersfield, California, United States, 93309
Rady Children's Hospital
San Diego, California, United States, 92123
Redwood Family Dermatology
Santa Rosa, California, United States, 95403
United States, Florida
Solution Through Advanced Research
Jacksonville, Florida, United States, 32256
Lenus Research and Medical Group
Sweetwater, Florida, United States, 33172
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Indiana
Dermatology Center of Northwestern Indiana
Crown Point, Indiana, United States, 46307
Pedia Research
Evansville, Indiana, United States, 47715
United States, Kentucky
Pedia Research
Owensboro, Kentucky, United States, 42301
United States, Michigan
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
United States, Nebraska
Midwest Children's Health-Northwoods
Lincoln, Nebraska, United States, 68505
Midwest Children's Health
Lincoln, Nebraska, United States, 68505
United States, Texas
Tekton Research
Austin, Texas, United States, 78745
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
United States, Virginia
The Education and Research Foundation
Lynchburg, Virginia, United States, 24501

Sponsors and Collaborators

Verrica Pharmaceuticals Inc.

Instat Consulting, Inc.

Paidion Research, Inc.

Database Integrations, Inc.

Investigators

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Principal Investigator:	Lawrence Eichenfield, MD	Rady Children's Hospital; San Diego, California

More Information

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Responsible Party:	Verrica Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT03377803 History of Changes
Other Study ID Numbers:	VP-102-102
First Posted:	December 19, 2017
Last Update Posted:	September 14, 2018
Last Verified:	August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		Yes
Pediatric Postmarket Surveillance of a Device Product:		No

Keywords provided by Verrica Pharmaceuticals Inc.:

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

Additional relevant MeSH terms:

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Molluscum Contagiosum; Poxviridae Infections; DNA Virus Infections; Virus Diseases; Skin Diseases, Viral; Skin Diseases, Infectious	Skin Diseases; Pharmaceutical Solutions; Cantharidin; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action