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Cancer Vaccine

HPV Vaccine for Warts

Phase 2 & 3

Recruiting

Led By Lowell Nicholson, MD

Research Sponsored by Western Institute for Veterans Research

Eligibility Criteria Checklist

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

Must have

Clinical diagnosis of cutaneous warts

Age 18 or older

Must not have

Anogenital warts

Active acute illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up quality of life assessments will occur at 0 (baseline), 4, 8, and 24 weeks (primary endpoint)

Summary

This trial tests if HPV vaccine can treat warts that don't respond to other treatments.

Who is the study for?

This trial is for adults over 18 with stubborn skin warts that haven't gone away after treatments like freezing, acids, or injections. Participants must understand the study and agree to it in writing. People can't join if they have genital or oral warts, are very sick right now, have a weak immune system, are allergic to HPV vaccines, might get pregnant, or had wart treatment in the last month.

What is being tested?

The study tests if the HPV vaccine can treat tough-to-remove skin warts compared to a placebo (a harmless saline solution). It's a double-blind trial where neither participants nor researchers know who gets the real vaccine or placebo until after results are collected.

What are the potential side effects?

Possible side effects of the HPV vaccine may include pain at injection site, headache, fever, nausea and dizziness. Severe allergic reactions are rare but possible for those sensitive to ingredients in the vaccine.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with skin warts.

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I am 18 years old or older.

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I have tried treatments for skin warts before.

Exclusion Criteria

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

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I have warts in the genital or anal area.

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I am currently experiencing a severe illness.

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I have warts in my mouth.

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I have skin warts that haven't been treated.

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I am on immunosuppressive therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ safety assessment will occur at 0, 4, 8, 20, and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~safety assessment will occur at 0, 4, 8, 20, and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and safety assessment will occur at 0, 4, 8, 20, and 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 24 weeks

Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 4 weeks

Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 8 weeks

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events

Skindex-16