RecruitingPhase 2Phase 3NCT05625633

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


Sponsor

Western Institute for Veterans Research

Enrollment

120 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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.)

Exclusion Criteria9

  • 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

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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 Center

Salt Lake City, Utah, United States

VA Salt Lake City Health Care System

Salt Lake City, Utah, United States

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NCT05625633


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