Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
262 participants
INTERVENTIONAL
2018-02-14
2018-09-26
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VP-102
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.
VP-102 - Cantharidin, Topical Film Forming Solution
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.
Placebo
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.
Placebo -Topical Film Forming Solution without VP-102
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.
Interventions
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VP-102 - Cantharidin, Topical Film Forming Solution
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.
Placebo -Topical Film Forming Solution without VP-102
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
2 Years
ALL
No
Sponsors
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Instat Consulting, Inc.
OTHER
Paidion Research, Inc.
INDUSTRY
Database Integrations, Inc.
INDUSTRY
Verrica Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lawrence Eichenfield, MD
Role: PRINCIPAL_INVESTIGATOR
Rady Children's Hospital; San Diego, California
Locations
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Bakersfield Dermatology
Bakersfield, California, United States
Rady Children's Hospital
San Diego, California, United States
Redwood Family Dermatology
Santa Rosa, California, United States
Solution Through Advanced Research
Jacksonville, Florida, United States
Lenus Research and Medical Group
Sweetwater, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Dermatology Center of Northwestern Indiana
Crown Point, Indiana, United States
Pedia Research
Evansville, Indiana, United States
Pedia Research
Owensboro, Kentucky, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Midwest Children's Health-Northwoods
Lincoln, Nebraska, United States
Midwest Children's Health
Lincoln, Nebraska, United States
Tekton Research
Austin, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
The Education and Research Foundation
Lynchburg, Virginia, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VP-102-102
Identifier Type: -
Identifier Source: org_study_id