Cantharidin for Common Warts

(COVE-2 Trial)

Not yet recruiting at 2 trial locations

Overseen By Project Manager

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Verrica Pharmaceuticals Inc.

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Immunosuppression, Uncontrolled diabetes, Malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 11 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness and safety of a new topical treatment, VP-102 (cantharidin), for common warts. Participants will apply the treatment or a placebo to their warts every few weeks over a 75-day period. The study seeks to determine if this treatment clears warts more effectively than no active medication. Individuals with at least one common wart in specific areas of the body, who are otherwise healthy and not using other wart treatments, might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use any wart-removing products other than the study drug during the trial. If you are taking systemic immunosuppressive medications, you must stop them 30 days before joining the study.

Is there any evidence suggesting that VP-102 is likely to be safe for humans?

Research has shown that VP-102, a skin treatment for common warts, is generally safe. Past studies found no serious side effects, indicating its safety for use. Some mild side effects might occur, but they are usually not severe. To prevent irritation, avoid using the treatment on sensitive areas like the face or groin. Overall, evidence supports VP-102 as a safe option for treating common warts. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for common warts?

Unlike the standard treatments for common warts, which often include salicylic acid and cryotherapy, VP-102 uses cantharidin as its active ingredient. This topical solution is unique because it leverages cantharidin's blistering properties to target and remove warts effectively. Researchers are excited about VP-102 because it offers a precise application method with its glass ampule applicator, potentially enhancing safety and minimizing side effects compared to more invasive treatments. Plus, with applications every 21 days, it could offer a convenient regimen for patients seeking a non-surgical option.

What evidence suggests that VP-102 might be an effective treatment for common warts?

Studies have shown that VP-102, which participants in this trial may receive, effectively treats common warts. In earlier research, 51% of patients had all their warts completely cleared, meaning more than half of the participants had no warts left after using the treatment. The study also found that the treatment was well-tolerated, causing no serious side effects. Additionally, the drug mostly remains on the skin where applied, which is a positive indication. These findings suggest VP-102 could be a promising option for people dealing with common warts. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with common warts, including plantar and verruca vulgaris. Participants should have a diagnosis of warts caused by the human papillomavirus (HPV). Specific eligibility criteria are not provided here, but typically include age range, health status, and number or size of warts.

Inclusion Criteria

Candidates must have no systemic or dermatologic disorder that will interfere with the study results or increase the risk of AEs

I agree not to swim or soak in water until the study drug is removed.

I can follow the study's instructions and complete all requirements.

Exclusion Criteria

Candidates with hypersensitivity or idiosyncratic reactions to the study drug or related compounds

I have warts in certain areas I choose not to treat.

I have not taken immunosuppressive medications in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment

Participants receive YCANTH (VP-102) or Vehicle treatment for common warts, with applications every 21 days for 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, with assessments at Day 105 and Day 147

9 weeks

2 visits (in-person)

Long-Term Follow-up

Participants may transition into a long-term follow-up study for continued treatment and monitoring

54 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VP-102

Trial Overview The study tests VP-102, a formulation containing cantharidin, against a placebo (vehicle) to see if it's effective and safe in treating common warts. It's a Phase 3 trial where participants are randomly assigned to receive either the treatment or placebo without knowing which one they get.

How Is the Trial Designed?

Group I: VP-102 Experimental Treatment 1 Intervention

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.

Group II: Vehicle Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Verrica Pharmaceuticals Inc.

Lead Sponsor

Trials

6

Recruited

810+

Torii Pharmaceutical Co. Ltd.

Collaborator

Medidata Solutions

Industry Sponsor

Trials

25

Recruited

25,600+

Canfield Scientific Inc.

Collaborator

Trials

3

Recruited

1,500+

Myonex LLC

Collaborator

Veeva Systems

Industry Sponsor

Trials

7

Recruited

3,400+

Allucent (US) LLC

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8484407/

COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy ... VP-102 under occlusion showed efficacy in complete clearance of common warts from baseline to day 84, as well as at follow-up visits out to day 147. The most ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07246590?locStr=United+States&country=United+States

Cantharidin Application in Patients With Common Warts ... This is a Phase 3, double-blind, randomized, vehicle-controlled study (Study number VP-CW-301; referred to as COVE-2 [Cantharidin and ...

3. verrica.com verrica.com/press_release/verrica-pharmaceuticals-achieves-positive-topline-results-in-phase-2-clinical-study-of-vp-102-in-patients-with-common-warts/

Verrica Pharmaceuticals Achieves Positive Topline Results ... 51% of subjects in Cohort 2 achieved complete clearance of all treatable warts. VP-102 was well-tolerated with no serious adverse events reported.

4. 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.

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/212905Orig1s000MultidisciplineR.pdf

212905Orig1s000 - accessdata.fda.gov Overall, the PK results indicate that there is a minimal systemic exposure of cantharidin following topical application of VP-102 0.7% solution ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/212905Orig1s000RiskR.pdf

212905Orig1s000 - accessdata.fda.gov 12. Verrica Pharmaceuticals Inc. Safety Update Report for Ycanth (cantharidin 0.7%) topical solution, NDA 212905. January 13, 2023.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07246590?aggFilters=funderType%3Aindustry%2Cstatus%3Anot%2CstudyType%3Aint&start=2025-01-01_

Cantharidin Application in Patients With Common Warts ... No partial treatment of treatable common warts is permitted, unless a subject would be required to exceed the maximum number of 2 applicators ...

8. jcadonline.com jcadonline.com/cantharidin-molluscum-contagiosum-body-region-post-hoc-analysis/

Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in ... Multiple treatment reviews for molluscum advise that compounded cantharidin should not be used in sensitive skin areas, such as the face or groin.7,11,17–21 It ...

9. ctv.veeva.com ctv.veeva.com/study/cantharidin-application-in-patients-with-common-warts-verruca-vulgaris-cove2

Cantharidin Application in Patients With Common Warts ... YCANTH (VP-102) or Vehicle will be applied by the Investigator or qualified member of the research team. Study drug will be applied to treatable ...