Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. ( 1 ) FDA label
Also known as VP-102
Cantharidin · 5 trials · 12 indications
To evaluate the efficacy of YCANTH (VP-102/TO-208) relative to Vehicle by assessing the proportion of subjects achieving complete clearance defined by complete resolution of all common warts as assessed visually by a Blinded Assessor of all treatable common warts, at the EOT Visit (Day 84).
To assess the safety of YCANTH (VP-102/TO-208) by assessing adverse events (AEs), including expected local skin reactions (LSRs).
To assess the safety of YCANTH (VP-102/TO-208) by assessing the change from baseline body temperature.
To assess the safety of YCANTH (VP-102/TO-208) by assessing the change in baseline in vital signs (pulse).
To assess the safety of YCANTH (VP-102/TO-208) by assessing concomitant medication use.
To evaluate the efficacy of continued dermal application of YCANTH (VP-102/TO-208) when applied to each common wart once every 21 days for a maximum of 4 additional treatments. \*Baseline in the study will be either 1) Treatment Visit 1 (Day 1) of the parent study for subjects who received YCANTH (VP-102/TO-208) during the parent study; 2) the first Treatment Visit of this study for subjects who received Vehicle in the parent study; or 3) Treatment Visit 1 of the parent study for subjects who received Vehicle in the parent study and did not receive YCANTH (VP-102/TO-208) during this study.
Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.
The primary objective is to determine any potential systemic exposure from a single 24-hour dermal application of VP-102 topical film-forming solution when applied to molluscum contagiosum (molluscum) lesions on pediatric subjects 2 years old and older.
| Arm | Type | Description |
|---|---|---|
| VP-102 (US) / TO-208 (Japan) | EXPERIMENTAL | US: Topical solution, which is a light violet to dark purple, slightly viscous liquid. Japan: Topical solution, which is clear to yellow, slightly viscous liquid. 0.7% (each mL contains 7 mg of cantharidin)/ glass ampule within an applicator. Each applicator contains 0.45 mL of 0.7% w/v cantharidin. Administered Topical/every 21 (± 4) days. All treatments will take place within a 75-day period. |
| Vehicle (US) / Vehicle (Japan) | PLACEBO_COMPARATOR | US: Topical solution, which is a light violet to dark purple, slightly viscous liquid. Japan: Topical solution, which is clear to yellow, slightly viscous liquid. No active drug/glass ampule within an applicator. Each applicator contains 0.45 mL without active cantharidin. Administered Topical/every 21 (± 4) days. All treatments will take place within a 75-day period. |
| VP-102/TO-208 | EXPERIMENTAL | Combination Product: Cantharidin |
| VP-102 | EXPERIMENTAL | Topical solution, which is a light violet to dark purple, slightly viscous liquid. 0.7% (each mL contains 7 mg of cantharidin)/glass ampule within an applicator. Each applicator contains 0.45 mL of 0.7% w/v cantharidin. Administered Topical/every 21 (± 4) days. All treatments will take place within a 75-day period. |
| Vehicle | PLACEBO_COMPARATOR | Topical solution, which is a light violet to dark purple, slightly viscous liquid. No active drug/glass ampule within an applicator. Each applicator contains 0.45 mL of 0.7% w/v cantharidin. Administered Topical/every 21 (± 4) days. All treatments will take place within a 75-day period. |
| Part A: VP-102 2 hour-Active | ACTIVE_COMPARATOR | For 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 Active | ACTIVE_COMPARATOR | For 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 Active | ACTIVE_COMPARATOR | For 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: Placebo | PLACEBO_COMPARATOR | For 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-Active | ACTIVE_COMPARATOR | Part 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-Placebo | PLACEBO_COMPARATOR | Part 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 Active | ACTIVE_COMPARATOR | For 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-Placebo | PLACEBO_COMPARATOR | Part B, VP-Placebo will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments. |
| Exposure Group | EXPERIMENTAL | This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator. |
| Standard Group | EXPERIMENTAL | This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator. |
| Name | Type | Description |
|---|---|---|
| VP-102 (US) / TO-208 (Japan) | COMBINATION_PRODUCT | A single-use applicator and applied in sufficient quantity to cover the entirety of each treatable common wart, including approximately a 1 to 2 mm margin of surrounding, healthy skin. The contents of no more than 2 applicators may be applied at each treatment visit. Each applicator contains 0.45 mL of 0.7% w/v cantharidin. Occlusive tape (occlusive tape with similar properties should be used across all clinical sites) will be applied to warts that have been treated. Once applied, the occlusive tape should be gently rubbed to maximize adherence to the treated area. |
| Vehicle (US) / Vehicle (Japan) | COMBINATION_PRODUCT | Vehicle is contained in a single-use applicator and applied in sufficient quantity to cover the entirety of each treatable common wart, including approximately a 1 to 2 mm margin of surrounding, healthy skin. The contents of no more than 2 applicators may be applied at each treatment visit. The Vehicle applicator contains the same excipient formulation as the VP-102/TO-208 applicator but does not contain the active pharmaceutical ingredient cantharidin. Occlusive tape (occlusive tape with similar properties should be used across all clinical sites) will be applied to warts that have been treated. Once applied, the occlusive tape should be gently rubbed to maximize adherence to the treated area. |
| Cantharidin | COMBINATION_PRODUCT | A single-use applicator and applied in sufficient quantity to cover the entirety of each treatable common wart, including approximately a 1 to 2 mm margin of surrounding, healthy skin. The contents of no more than 2 applicators may be applied at each treatment visit. Each applicator contains 0.45 mL of 0.7% w/v cantharidin. Occlusive tape (occlusive tape with similar properties should be used across all clinical sites) will be applied to warts that have been treated. Once applied, the occlusive tape should be gently rubbed to maximize adherence to the treated area. |
| VP-102 | COMBINATION_PRODUCT | A single-use applicator and applied in sufficient quantity to cover the entirety of each treatable common wart, including approximately a 1 to 2 mm margin of surrounding, healthy skin. The contents of no more than 2 applicators may be applied at each treatment visit. Each applicator contains 0.45 mL of 0.7% w/v cantharidin. Occlusive tape (occlusive tape with similar properties should be used across all clinical sites) will be applied to warts that have been treated. Once applied, the occlusive tape should be gently rubbed to maximize adherence to the treated area. |
| Vehicle | COMBINATION_PRODUCT | Vehicle is contained in a single-use applicator and applied in sufficient quantity to cover the entirety of each treatable common wart, including approximately a 1 to 2 mm margin of surrounding, healthy skin. The contents of no more than 2 applicators may be applied at each treatment visit. The Vehicle applicator contains the same excipient formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin. Occlusive tape (occlusive tape with similar properties should be used across all clinical sites) will be applied to warts that have been treated. Once applied, the occlusive tape should be gently rubbed to maximize adherence to the treated area. |
| VP-102 and applicator | COMBINATION_PRODUCT | In 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. |
| Placebo | COMBINATION_PRODUCT | The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin |
| VP-102 with applicator | COMBINATION_PRODUCT | Subjects will receive treatment to their molluscum contagiosum with VP-102. |
Inclusion Criteria: Candidates will be included in the study if they: 1. Are male or female patients ≥ 2 years of age. 2. Are immunocompetent. 3. Have a minimum of 1 treatable common wart (verruca vulgaris) of any size and height: 1. Common warts are considered treatable if they are located an...
Cantharidin is being developed to treat common warts (verruca vulgaris), condylomata acuminata (external genital warts), and molluscum contagiosum. It is a small molecule applied topically. The common wart program is the most advanced, with Phase 3 trials enrolling patients two years of age and older in the United States and Japan.
Cantharidin is developed by Verrica Pharmaceuticals Inc., which trades on the Nasdaq under the ticker VRCA. Verrica is advancing the candidate, also referred to as VP-102, across common warts, external genital warts, and molluscum contagiosum.
Cantharidin is in Phase 3 clinical development for common warts. It is investigational and has not been approved by the FDA for these wart indications. Three Phase 3 trials are currently recruiting, and a completed Phase 2 study evaluated the candidate in external genital warts.
Three Phase 3 trials are recruiting: COVE-3 (NCT07637734) and COVE-2 (NCT07246590), each enrolling about 300 patients with common warts, and a long-term follow-up study (NCT07457918) enrolling about 600 patients. A completed Phase 2 trial (NCT03981822) studied VP-102 in external genital warts.
Yes. Cantharidin is also known as VP-102, including VP-102 with applicator, and as TO-208 in Japan. The naming reflects the same investigational product developed by Verrica Pharmaceuticals, so search results for VP-102 or TO-208 refer to this cantharidin candidate.
The Phase 3 common wart trials are randomized, double-blind, and placebo-controlled, enrolling patients aged two years and older. COVE-2 and COVE-3 each plan about 300 participants, while the long-term follow-up study plans about 600, with sites in the United States and Japan.