Clinical trial NCT03377790: Cantharidin Application in Molluscum Patients-1
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Molluscum Contagiosum
Keywords: Molluscum
Skin Diseases
Poxviridae Infections
Skin Diseases; Infectious
Skin Diseases; Viral
DNA Poxvirus
Lead sponsor: Verrica Pharmaceuticals Inc.
Sponsor class: INDUSTRY
Collaborators: name: Instat Consulting, Inc.
name: Paidion Research, Inc.
name: Database Integrations, Inc.
First posted: 2017-12-19
Enrollment: 266
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS)
timeFrame: Day 1 (Baseline and new) compared to Day 84 (EOS)
Secondary outcomes:
measure: Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit
timeFrame: Day 1 (Baseline and new) compared to Day 63
measure: Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit
timeFrame: Day 1 (Baseline and new) compared to Day 42
measure: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit
timeFrame: Day 1 (Baseline and new) compared to Day 21
Other outcomes:
measure: 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.
timeFrame: Baseline to Day 84 (EOS)
measure: Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit
timeFrame: Day 1 (Baseline) compared to Day 84 (EOS)
measure: Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.
timeFrame: Day 1 (Baseline) compared to Day 84 (EOS)
measure: Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.
timeFrame: Day 1 (Baseline) compared to Day 84 (EOS)
measure: Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.
timeFrame: Day 1 (Baseline) compared to Day 84 (EOS)
measure: Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject.
timeFrame: Days 1, 21, 42, 63 and 84 (EOS).
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Boynton Beach
country: United States
facility: Study Protocol, Inc.,
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute
state: Florida
city: Spring Hill
country: United States
facility: ASCLEPES Research Center
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Oakbrook Terrace
country: United States
facility: Summit Dermatology
state: Illinois
city: Clarkston
country: United States
facility: Clarkston Skin Research
state: Michigan
city: Saint Louis
country: United States
facility: St Louis Children's Hospital
state: Missouri
city: Lincoln
country: United States
facility: Midwest Children's Hospital
state: Nebraska
city: Brooklyn
country: United States
facility: Kings County Hospital
state: New York
city: Chapel Hill
country: United States
facility: University North Carolina Dermatology Center
state: North Carolina
city: Fairfield
country: United States
facility: The Pediatric Associates of Fairfield, Inc
state: Ohio
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: Houston
country: United States
facility: Center for Skin Research
state: Texas
city: Plano
country: United States
facility: ACRC Trials Plano Pediatrics
state: Texas
Study officials:
affiliation: Rady Children's Hospital; San Diego, California
name: Lawrence Eichenfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.