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VP-102 and applicator

Phase 2

Condylomata Acuminata | Small molecule | Infectious Disease |Verrica Pharmaceuticals Inc.|Last Updated: Nov 27, 2024

Target and mechanism

ModalitySmall molecule

Also known as VP-102

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment105

FDA Designations

No designations recorded

Clinical trial landscape

VP-102 and applicator · 1 trial · 8 indications

Phase 2 1
NCT03981822A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital WartsCondylomata Acuminata
COMPLETED105 Analytics
PHASE2COMPLETED
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts
Condylomata AcuminataUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.
Compares baseline wart count to Day 84, end of treatment.

Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.

Secondary Endpoints

Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Clearance compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Compared from baseline to each study visit, treatment 2, (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: VP-102 2 hour-ActiveACTIVE_COMPARATORFor part A, VP-102 will be applied for 2 hours and removed. If selected as a dose regimen for Part B VP-102 will be applied for 2 hours and removed.In both parts, VP-102 is applied every 21 days for 4 treatments.
Part A: VP-102 6-hour ActiveACTIVE_COMPARATORFor part A, VP-102 will be applied for 6 hours and removed. If selected as a dose regimen for Part B VP-102 will be applied for 6 hours and removed. In both parts, VP-102 is applied every 21 days for 4 treatments.
Part A: VP-102 24-hour ActiveACTIVE_COMPARATORFor part A, VP-102 will be applied for 24 hours and removed. If selected as a dose regimen for Part B, VP-102 will be applied for 24 hours and removed. In both parts, VP-102 is applied every 21 days for 4 treatments.
Part A: PlaceboPLACEBO_COMPARATORFor part A, VP-102 will be applied for 2-,6- or 24- hours and removed. Placebo is applied every 21 days for 4 treatments.
Part B & A: VP-102 6 hour-ActiveACTIVE_COMPARATORPart B, VP-102 will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.
Part B & A: 6-hour-PlaceboPLACEBO_COMPARATORPart B, Placebo will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.
Part B & A: VP-102 24-hour ActiveACTIVE_COMPARATORFor part A, VP-102 will be applied for 24 hours and removed. If 24 hours is selected as a dose regimen for Part B, VP-102 will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments.
Part B & A: 24-hour-PlaceboPLACEBO_COMPARATORPart B, VP-Placebo will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments.

Interventions

NameTypeDescription
VP-102 and applicatorCOMBINATION_PRODUCTIn part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
PlaceboCOMBINATION_PRODUCTThe placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria: * Be healthy, immunocompetent males or females ≥ 18 years of age * Present with ≥ 2 and ≤ 30 external genital and/or perianal warts in ≥ 1 of the following anatomic areas: * In both sexes: medial thigh (except inguinal fold); supra-pubic, perineal, and perianal areas * ...

Countries:United States
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Frequently asked questions about VP-102 and applicator

What is VP-102 used for?

VP-102 is an investigational small molecule being developed by Verrica Pharmaceuticals Inc. (VRCA) for the treatment of molluscum contagiosum, condylomata acuminata (external genital warts), and common warts. It is currently in clinical development and has not been approved by the FDA.

What does VP-102 target?

VP-102 contains cantharidin, a topical agent that is applied directly to skin lesions. It is being studied for its effects on viral skin infections including molluscum contagiosum, external genital warts caused by human papillomavirus, and common warts.

Who makes VP-102?

VP-102 is developed by Verrica Pharmaceuticals Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol VRCA. The drug is also known as TO-208 in Japan.

What phase is VP-102 in?

VP-102 has completed Phase 2 trials for molluscum contagiosum and external genital warts. It is currently being evaluated in two Phase 3 trials for common warts, which are actively recruiting participants in the United States and Japan.

What clinical trials is VP-102 in?

VP-102 has completed two Phase 2 trials: NCT03186378 in molluscum contagiosum and NCT03981822 in external genital warts. Two Phase 3 trials, NCT07246590 and NCT07637734, are currently recruiting for common warts, with a combined target enrollment of 600 participants.

Is VP-102 the same as TO-208?

Yes, VP-102 is also known as TO-208 in Japan. The drug is referred to as VP-102 in the United States and as VP-102/TO-208 internationally. Both names refer to the same cantharidin-based topical treatment.