What is the human papillomavirus (HPV) vaccine studying for refractory cutaneous warts?

This trial is studying the HPV vaccine to see if it can help treat difficult-to-treat cutaneous warts. Researchers want to find out if the vaccine can reduce or clear these warts and improve quality of life. The study is sponsored by the Western Institute for Veterans Research.

Who may be eligible for this warts clinical trial?

Adults aged 18 or older with a diagnosis of cutaneous warts who have tried prior treatments may be eligible. Both men and women can participate. Important factors include not having untreated warts, not being pregnant, and no recent wart treatments. Please review eligibility criteria for more details.

Is there any cost to participate in this warts clinical trial?

Study-related care, including the study vaccine or placebo and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID05625633

Human Papillomavirus HPV Vaccination for the Treatment of Refractory Cutaneous Warts A Randomized, Placebo-Controlled, Double-Blinded Trial

Led by Western Institute for Veterans Research · Updated on 2024-04-05

120

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of the human papillomavirus HPV vaccine for treating refractory cutaneous warts, which are common skin growths that can be painful, persistent, and difficult to treat. This randomized, double-blinded, placebo-controlled trial aims to determine if HPV vaccination can be an effective therapy for these stubborn warts, as current treatments often fail and warts can cause significant discomfort and distress. Participants will be randomly assigned to receive either the 9-valent HPV vaccine or a placebo. Injections are given as a 0.5-mL intramuscular dose at weeks 0, 4, and 20. The study includes 120 participants and follows them for 24 weeks to assess the vaccines effect on wart resolution and participants quality of life. During the trial, participants will have regular evaluations including assessments of their wart response at 4, 8, and 24 weeks after the first dose. Quality of life will be measured at multiple time points using the Skindex-16 questionnaire. Safety will be monitored throughout the study by recording any adverse events. The entire study duration for participants is 24 weeks, during which they will attend scheduled visits for injections and evaluations.

CONDITIONS

Brief Title

Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Must be able to understand and provide written informed consent
Age 18 or older
Clinical diagnosis of cutaneous warts
Must have received prior treatment for cutaneous warts (such as curettage, cryotherapy, salicylic acid, intralesional Candida antigen injection, etc.)

You will not qualify if you...

Untreated cutaneous warts
Anogenital warts
Oral warts
Treatment for cutaneous warts in the past 4 weeks
Active acute illness
Immunosuppression
Known hypersensitivity to HPV vaccination
Subjects may not receive any other investigational treatment
Pregnancy or planned pregnancy during the study period

Research Team

Lowell Nicholson, MD

Jamie Rhoads, MD

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