HPV vaccination for treating stubborn skin warts
Human Papillomavirus (HPV) Vaccination for the Treatment of Refractory Cutaneous Warts: A Randomized, Placebo-Controlled, Double-Blinded Trial
This study is testing if the HPV vaccine can help adults with stubborn skin warts get better compared to a placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western Institute for Veterans Research Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Salt Lake City, Utah and 1 other locations) |
| Trial ID | NCT05625633 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the human papillomavirus (HPV) vaccine in treating refractory cutaneous warts by comparing it to a placebo. Participants aged 18 and older with a clinical diagnosis of cutaneous warts who have previously undergone treatment will be randomly assigned to receive either the HPV vaccine or a saline placebo. The study aims to assess the efficacy of the vaccine in resolving warts, which can be painful and disfiguring, and to provide a potentially less invasive treatment option. The trial will be conducted at multiple centers, ensuring a diverse participant pool.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a clinical diagnosis of refractory cutaneous warts who have previously received treatment.
Not a fit: Patients with untreated cutaneous warts, anogenital warts, or those who are immunosuppressed may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from persistent cutaneous warts.
How similar studies have performed: Preliminary data from smaller studies suggest that HPV vaccination may be effective for treating warts, but this is the first large-scale randomized controlled trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Must be able to understand and provide written informed consent 2. Age 18 or older 3. Clinical diagnosis of cutaneous warts 4. Must have received prior treatment for cutaneous warts (such as curettage, cryotherapy, salicylic acid, intralesional Candida antigen injection, etc.) Exclusion Criteria: 1. Untreated cutaneous warts 2. Anogenital warts 3. Oral warts 4. Treatment for cutaneous warts in the past 4 weeks 5. Active acute illness 6. Immunosuppression 7. Known hypersensitivity to HPV vaccination 8. Subjects may not receive any other investigational treatment 9. Pregnancy or planned pregnancy during the study period
Where this trial is running
Salt Lake City, Utah and 1 other locations
- University of Utah Midvalley Health Center — Salt Lake City, Utah, United States (Recruiting)
- VA Salt Lake City Health Care System — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Lowell Nicholson, MD — University of Utah Health Care System
- Study coordinator: Lowell Nicholson, MD
- Email: lowell.nicholson@hsc.utah.edu
- Phone: 801-581-2121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.