Actively Recruiting
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
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
W
Western Institute for Veterans Research
Lead Sponsor
U
University of Utah
Collaborating Sponsor
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 vaccine's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 weeks
Participants receive either the HPV vaccine or a placebo through intramuscular injections at weeks 0, 4, and 20.
5 visits (in-person) at weeks 0, 4, 8, 20, and 24 for injections and assessments
Duration - 4 weeks
Participants are monitored for treatment response, quality of life, and safety up to 24 weeks after the first dose.
1 visit (in-person) at week 24
Trial Site Locations
Total: 2 locations
1
University of Utah Midvalley Health Center
Salt Lake City, Utah, United States, 84107
Actively Recruiting
2
VA Salt Lake City Health Care System
Salt Lake City, Utah, United States, 84148
Actively Recruiting
Research Team
L
Lowell Nicholson, MD
J
Jamie Rhoads, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here