300 Participants NeededMy employer runs this trial

Cantharidin for Common Warts

(COVE-3 Trial)

Recruiting at 19 trial locations
PM
Overseen ByProject Manager
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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

8. Provide written informed consent or assent in a manner approved by the IRB and/or have a parent/guardian provide written informed consent as evidenced by the signature on an IRB approved assent/consent form. Subjects who turn 18 years of age (or legal age per state or country) during the study will be required to re-consent to remain on the study.
9. Provide written authorization for use and disclosure of protected health information (per state and/or country requirements).
7. Agree not to use any wart-removing product (prescription or over-the-counter) other than the study drug during the course of the study, with the exception of circumstances allowed under Inclusion Criterion 3b.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 8 weeks

Treatment

Participants receive YCANTH (VP-102/TO-208) or Vehicle treatment for common warts every 21 days, up to 4 sessions

11 weeks
4 visits (in-person), multiple follow-up calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 weeks
2 visits (in-person)

Long-Term Follow-up (optional)

Participants may opt into continuation of treatment and monitoring for up to 54 weeks

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

Group I: VP-102 (US) / TO-208 (Japan)Experimental Treatment1 Intervention
Group II: Vehicle (US) / Vehicle (Japan)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Verrica Pharmaceuticals Inc.

Lead Sponsor

Trials
6
Recruited
810+

Torii Pharmaceutical Co. Ltd.

Collaborator

CMIC Co, Ltd. Japan

Industry Sponsor

Trials
11
Recruited
3,800+

Canfield Scientific Inc.

Industry Sponsor

Medidata Solutions

Industry Sponsor

Trials
25
Recruited
25,600+

Veeva Systems

Industry Sponsor

Trials
7
Recruited
3,400+

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 ...

First 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.