NCT05625633

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

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Western Institute for Veterans Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 improvement. An efficacious therapy for cutaneous warts is sorely needed and treatment with HPV vaccination is being increasingly reported. Notably, individual cases and case series have reported complete resolution of multiple treatment refractory warts after treatment with the quadrivalent HPV vaccine. Even more encouraging, a larger retrospective study of 30 patients found that up to 60% of patients had a complete or partial response after treatment with the HPV vaccine. Additional benefits of treatment with HPV vaccination include ease of use, less tissue destruction and pain, and the potential for less frequent medical office visits. Despite these promising preliminary data, a larger, randomized controlled study has yet to be performed. This will be a multi-center, double-blinded, randomized, placebo-controlled trial with 120 participants. Enrolled participants will be randomized to treatment with either HPV vaccination or placebo. Participants will receive injections with the 9-valent HPV vaccine or placebo at 0, 4, and 20 weeks and follow up until 24 weeks to determine their treatment response, quality of life and the safety and tolerability of HPV vaccination.

Conditions

• Warts

Interventions

Type	Name	Description
BIOLOGICAL	Human Papillomavirus 9-valent Vaccine, Recombinant	0.5-mL suspension of 9-valent Gardasil administered as intramuscular injection at weeks 0, 4, and 20
OTHER	Normal Saline	0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20

Timeline

• Start date: 2024-03-25
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2022-11-23
• Last updated: 2024-04-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study