600 Participants NeededMy employer runs this trial

Cantharidin for Common Warts

(COVE-4 Trial)

Recruiting at 3 trial locations
PM
Overseen ByProject Manager
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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 tests the safety and effectiveness of a treatment called YCANTH (also known as cantharidin) for common warts. Researchers aim to determine how well this treatment clears warts when applied every 21 days, up to four times. They also monitor any side effects, such as skin reactions. Individuals from previous studies who still have treatable warts may be suitable for this trial, particularly if they can refrain from swimming or using other wart treatments during the study. As a Phase 3 trial, this represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot take systemic immunosuppressive medications or have had certain wart treatments within 30 days before starting the study. Routine use of local corticosteroids is allowed.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that cantharidin, the treatment under study, is generally safe for people. The FDA has already approved it for treating molluscum contagiosum, a skin condition, in adults and children aged 2 and older. Studies have found that when used correctly, cantharidin is safe, and complications are rare. Most side effects include temporary skin reactions, such as blistering, mild pain, redness, or a burning sensation. These reactions are expected and align with past experiences with cantharidin. No serious issues, such as scarring or systemic effects, have been reported when a doctor applies it correctly.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for common warts, such as cryotherapy and salicylic acid, Cantharidin is derived from a natural compound found in blister beetles. This unique active ingredient works by causing the outer layer of the skin to blister, which helps to remove the wart more effectively. Researchers are excited about Cantharidin because it offers a non-invasive application method that can be painless compared to the discomfort often associated with freezing warts. Additionally, its targeted action may lead to quicker results and reduced recurrence rates, making it a promising alternative to current options.

What evidence suggests that YCANTH (VP-102/TO-208) might be an effective treatment for common warts?

Research has shown that Cantharidin, also known as YCANTH or VP-102, effectively treats common warts. In earlier studies, 51% of patients had all their warts cleared within 84 days. The treatment causes the skin to blister, aiding in wart removal. These results offer promise for those dealing with common warts. Participants in this trial will receive the experimental combination product containing Cantharidin.26789

Who Is on the Research Team?

AA

Adelaide A Hebert, MD

Principal Investigator

UTHealth McGovern Medical School - Houston

Are You a Good Fit for This Trial?

This trial is for people who finished the earlier COVE-2 or COVE-3 studies, have at least one common wart left to treat, and can follow study instructions. Participants must agree not to swim or soak in water after each treatment until told it's safe.

Inclusion Criteria

I am willing to give written permission to use my health information.
I agree not to swim or bathe until the study drug is removed after each treatment.
I am willing and able, or my guardian is able, to follow all study instructions.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive YCANTH (VP-102/TO-208) applied to common warts every 21 days for up to 4 treatments or until clearance

12 weeks
Up to 4 visits (in-person)

Observation

Participants with complete clearance attend observation visits every 42 days without treatment

Approximately 36 weeks
Up to 6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness until the End-of-Study Visit on Day 378

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cantharidin

Trial Overview

The study looks at long-term safety and effectiveness of YCANTH (cantharidin) applied by a healthcare provider every 21 days (up to four times) on remaining warts. If new warts appear, treatment may resume. The goal is complete wart clearance.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: VP-102/TO-208Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Verrica Pharmaceuticals Inc.

Lead Sponsor

Trials
6
Recruited
810+

Canfield Scientific Inc.

Industry Sponsor

Medidata Solutions

Industry Sponsor

Trials
25
Recruited
25,600+

Veeva Systems

Industry Sponsor

Trials
7
Recruited
3,400+

Torii Pharmaceuticals CO., LTD

Collaborator

Allucent (US) LLC

Collaborator

Myonex LLC

Collaborator

CMIC Co, Ltd. Japan

Industry Sponsor

Trials
11
Recruited
3,800+

Citations

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 maximum of 4 ...

COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy ...

VP-102 showed efficacy in complete clearance of common warts from baseline to day 84, as well as at follow-up visits. Due to the higher percentage of patients ...

Cantharidin Application in Patients With Common Warts ...

Candidates will be included in the study if they: Are male or female patients ≥ 2 years of age. Are immunocompetent. Have a minimum of 1 treatable common wart ( ...

Verrica Pharmaceuticals Achieves Positive Topline Results ...

Results showed 51% of subjects (18 of 35) treated with VP-102 in Cohort 2 achieved complete clearance of all treatable warts at Day 84.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34286459/

COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy ...

VP-102 showed efficacy in complete clearance of common warts from baseline to day 84, as well as at follow-up visits.

A Retrospective Study of Clinical Efficacy of Cantharidin ...

The results from this study demonstrated that external cantharidin cream therapy could be served as an alternative treatment for Verruca plantaris.

Common Warts Publications

Cantharidin Use in Common Warts · Seventy-six digital and periungual warts in 40 patients were treated topically with cantharidin, a potent blistering agent.

212905Orig1s000 - accessdata.fda.gov

The clinical reviewer concluded that the safety data demonstrate that cantharidin appears safe for treatment of molluscum lesions in adults ...

Cantharidin: Uses, Interactions, Mechanism of Action

Cantharidin is approved by the FDA for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.