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VP-102 Cantharidin, film forming

Phase 3

Molluscum Contagiosum | Small molecule | Dermatology |Verrica Pharmaceuticals Inc.|Last Updated: Jan 11, 2022

Target and mechanism

ModalitySmall molecule

Also known as VP-102 Cantharidin, topical film forming solution, VP-102 - Cantharidin, Topical Film Forming Solution, VP-102- Cantharidin, Film Forming

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment528

FDA Designations

No designations recorded

Clinical trial landscape

VP-102 Cantharidin, film forming · 2 trials · 1 indication

Phase 3 2
NCT03377790Cantharidin Application in Molluscum Patients-1Molluscum Contagiosum
COMPLETED266 Analytics
NCT03377803Cantharidin Application in Molluscum PatientsMolluscum Contagiosum
COMPLETED262 Analytics
PHASE3COMPLETED
Cantharidin Application in Molluscum Patients-1
Molluscum ContagiosumUnlock trial analytics
PHASE3COMPLETED
Cantharidin Application in Molluscum Patients
Molluscum ContagiosumUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VP-102ACTIVE_COMPARATORVP-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.
PlaceboPLACEBO_COMPARATORPlacebo 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.

Interventions

NameTypeDescription
VP-102 - Cantharidin, Topical Film Forming SolutionCOMBINATION_PRODUCTVP-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-102COMBINATION_PRODUCTPlacebo 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.
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Eligibility Criteria

Age Range2 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

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 eye...

Countries:United States
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