Cantharidin for Common Warts
(COVE-3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of a new topical treatment, VP-102, for removing common warts. The treatment contains cantharidin and is being tested for its safety and effectiveness when applied to the skin. Individuals with at least one treatable common wart, excluding sensitive areas like the face or under the nails, may qualify for this study. The trial will compare the active treatment to a placebo (a solution with no active ingredients) to determine its true impact. Participants must avoid other wart treatments during the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.
Is there any evidence suggesting that VP-102 / TO-208 treatment is likely to be safe for humans?
Research has shown that VP-102, a cream for common warts, is generally safe. In earlier studies, participants tolerated VP-102 well, and no serious side effects occurred. The FDA has approved cantharidin, the main ingredient in VP-102, for treating molluscum contagiosum, indicating recognized safety by health authorities. Additionally, the treatment primarily remains on the skin and does not spread significantly in the body, reducing the risk of side effects. Overall, evidence supports the safety of VP-102 for treating common warts.12345
Why do researchers think this study treatment might be promising for common warts?
Researchers are excited about VP-102 (US) / TO-208 (Japan) because it offers a novel approach to treating common warts with cantharidin, a compound that hasn't been widely available in a standardized form until now. Unlike traditional wart treatments like cryotherapy or salicylic acid, which can take weeks or even months to show effectiveness, this topical solution is designed to be applied every 21 days for a short period of 75 days, potentially speeding up results. The solution's unique formulation ensures precise delivery of the active ingredient, which could lead to more consistent and effective outcomes in dissolving warts.
What evidence suggests that VP-102 might be an effective treatment for common warts?
Research has shown that VP-102, a skin treatment for common warts, delivers promising results. In earlier studies, about 51% of patients had all their warts completely gone by day 84 after using this treatment. This means more than half of the participants saw their warts fully disappear within three months. In this trial, participants will receive either VP-102 or a placebo vehicle. The treatment generally caused mild or moderate side effects. These results suggest that VP-102 could effectively eliminate common warts.12467
Are You a Good Fit for This Trial?
This trial is for people age 2 and older with common warts (not on the soles, under nails, near eyes, mouth, nose, ears, or genitals) who are otherwise healthy and can follow study instructions. Participants can't use other wart treatments during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive YCANTH (VP-102/TO-208) or Vehicle treatment for common warts every 21 days, up to 4 sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-Term Follow-up (optional)
Participants may opt into continuation of treatment and monitoring for up to 54 weeks
What Are the Treatments Tested in This Trial?
Interventions
- VP-102 / TO-208
Trial Overview
The study compares a topical treatment called YCANTH (cantharidin solution) to a placebo liquid in treating common warts. Participants are randomly assigned to one of the two groups without knowing which they receive.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Verrica Pharmaceuticals Inc.
Lead Sponsor
Torii Pharmaceutical Co. Ltd.
Collaborator
CMIC Co, Ltd. Japan
Industry Sponsor
Canfield Scientific Inc.
Industry Sponsor
Medidata Solutions
Industry Sponsor
Veeva Systems
Industry Sponsor
Allucent (US) LLC
Collaborator
Myonex LLC
Collaborator
Citations
COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy ...
This phase 2 clinical trial demonstrated the safety and efficacy of treatment of common warts with VP-102 in two treatment cohorts. Treatment with VP-102 ...
Common Warts Publications
Most LSRs were mild or moderate in severity. Conclusion: VP-102 showed efficacy in complete clearance of common warts from baseline to day 84, as well as at ...
Study Details | NCT07637734 | Cantharidin Application in ...
To evaluate the efficacy of YCANTH (VP-102/TO-208) relative to Vehicle by assessing the proportion of subjects achieving complete clearance ...
Long-Term Follow-up Study of Cantharidin (YCANTH [VP- ...
To evaluate the efficacy of continued skin application of YCANTH (VP-102/TO-208) when applied to each common wart once every 21 days for a ...
5.
dermatologytimes.com
dermatologytimes.com/view/first-patient-dosed-in-phase-3-vp-102-common-warts-programFirst Patient Dosed in Phase 3 VP-102 Common Warts ...
Topline results from cohort 2 showed that 51% of treated subjects (18 of 35) achieved complete clearance of all treatable warts at day 84.
Verrica Pharmaceuticals Achieves Positive Topline Results ...
VP-102 was well-tolerated with no serious adverse events reported Common warts affect approximately 22 million people in the United States
Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in ...
These studies showed significantly higher complete clearance and safety of VP-102 by body region compared to vehicle.
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