Human Papillomavirus (HPV) Vaccination for the Treatment of Refractory Cutaneous Warts: A Randomized, Placebo-Controlled, Double-Blinded Trial
Western Institute for Veterans Research
Summary
This double-blinded clinical trial randomly assigns participants with refractory cutaneous warts to receive either treatment with the human papillomavirus (HPV) vaccine or a placebo to assess the efficacy of HPV vaccination for the treatment of refractory cutaneous warts.
Description
Cutaneous warts are a common cause for medical office visits and are frequently encountered in dermatology practice. Despite their benign nature, cutaneous warts can be painful, disfiguring, persistent and may be associated with significant morbidity. Numerous therapeutic options are available, including local destruction, virucidal agents, topical and systemic antiproliferative medications, and immunotherapy. Unfortunately, no single therapy is uniformly effective, and patients often receive multiple courses of treatment (cryotherapy, curettage, Candida antigen injection, etc.) without improv…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Pre…
Interventions
- BiologicalHuman Papillomavirus 9-valent Vaccine, Recombinant
0.5-mL suspension of 9-valent Gardasil administered as intramuscular injection at weeks 0, 4, and 20
- OtherNormal Saline
0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20
Locations (2)
- University of Utah Midvalley Health CenterSalt Lake City, Utah
- VA Salt Lake City Health Care SystemSalt Lake City, Utah