What side effects are associated with this type of intervention?

Common treatments for warts, such as topical salicylic acid, cryotherapy, and topical immunotherapy, have various side effects. Salicylic acid may cause skin irritation, peeling, and discomfort. Cryotherapy can result in pain, blistering, and potential scarring. Topical immunotherapy, like imiquimod, often leads to local skin reactions including redness, swelling, itching, and burning. Severe dermatitis is a notable side effect of topical immunotherapy, with other potential side effects including lymphadenopathy, urticaria, vitiligo, and dyschromia.

What prior FDA approvals exist?

The FDA has approved several treatments for warts, including topical agents like salicylic acid and imiquimod, which work by stimulating the immune system to fight the virus causing the warts. Additionally, cryotherapy using liquid nitrogen and laser treatments are also commonly used. Antiviral treatments such as cidofovir have shown efficacy in some cases. These treatments aim to remove the warts or boost the body's immune response to clear the infection.

What other types of research exist?

Promising novel alternatives to the VDMN-21 patch for treating warts include: 1) Beremagene geperpavec (B-VEC), a topical gene therapy that has shown efficacy in wound healing for epidermolysis bullosa, 2) Tacrolimus ointment, which has demonstrated effectiveness in reducing scarring and could potentially be repurposed for warts, and 3) Thymosin beta-4, which has shown enhancement in healing venous ulcers and may offer benefits for wart treatment.

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Virus Therapy

VDMN-21 Patch for Warts

Phase 2

Recruiting

Research Sponsored by Veradermics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is a male or non-pregnant female, 18 to 65 years of age

Females must be post-menopausal, surgically sterile, or use an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Baseline

Must not have

Subject used or will use oral zinc and/or cimetidine within 30 days prior to enrollment or during the course of the study

Subject has received 3 or more prior treatments to the Target Lesion without resolution

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to day 134

Summary

This trial tests the safety and effectiveness of the VDMN-21 patch for treating warts. It includes people with common warts that are difficult to treat. The patch works by applying medicine directly to the wart to help get rid of it.

Who is the study for?

This trial is for adults aged 18-65 with 1 to 8 common warts. Participants must be in good health, not pregnant, and willing to follow the study plan including telehealth visits. They can't have used certain wart treatments recently or be on immunosuppressive therapy, and they shouldn't have a history of significant eye inflammation or active cancer (except non-melanoma skin cancer).

What is being tested?

The trial tests two doses of VDMN-21 Patch against a placebo patch to see if they're safe and effective for treating common warts. Participants will receive repeated treatment sessions with one of these patches.

What are the potential side effects?

While specific side effects are not listed here, participants may experience reactions at the site where the patch is applied such as redness, itching, or irritation. Systemic side effects could occur depending on how the body absorbs ingredients from the patch.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old and not pregnant.

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I am a woman who cannot become pregnant or am using birth control and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have taken or will take zinc or cimetidine within 30 days before joining the study or during it.

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I've had 3 or more treatments for my specific cancer area without it getting better.

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I am not currently being treated for any cancer except nonmelanoma skin cancer.

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I have had serious eye inflammation, like uveitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to day 134

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to day 134

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 134 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of subjects with complete clinical resolution of the Target Lesion at end of treatment period

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment Group B (High Dose)Experimental Treatment1 Intervention

High does patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month).

Group II: Treatment Group A (Low Dose)Experimental Treatment1 Intervention

Low does patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month).

Group III: Treatment Group C (Vehicle)Placebo Group1 Intervention

Vehicle patch will be applied adjacent to the target wart and remain in place for 5 minutes then removed. There may be up to 6 treatments (approximately 1 per month).

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for warts include topical agents like salicylic acid, which works by exfoliating the infected skin and promoting immune response; cryotherapy, which involves freezing the wart tissue to cause cell destruction; and immunotherapy, which stimulates the body's immune system to attack the wart-causing virus. Understanding these mechanisms is crucial for patients as it helps them comprehend how the treatments work, the expected outcomes, and potential side effects, enabling informed decisions about their care.