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

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.

Study Overview

• Status: Recruiting
• Conditions: Warts
• Intervention / Treatment: Biological: Human Papillomavirus 9-valent Vaccine, Recombinant; Other: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Lowell Nicholson, MD; Phone Number: 801-581-2121; Email: lowell.nicholson@hsc.utah.edu
• Study Contact Backup: Name: Jamie Rhoads, MD; Phone Number: 801-581-2121; Email: jamie.rhoads@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84148
      • Recruiting
      • VA Salt Lake City Health Care System
      • Principal Investigator: Jamie Rhoads, MD
      • Sub-Investigator: Stephanie Klein, MD
      • Contact: Jamie Rhoads, MD; Phone Number: 801-582-1565; Email: jamie.rhoads@hsc.utah.edu
      • Sub-Investigator: Lowell Nicholson, MD
    • Salt Lake City, Utah, United States, 84107
      • Recruiting
      • University of Utah Midvalley Health Center
      • Contact: Lowell Nicholson, MD; Phone Number: 801-581-2121; Email: lowell.nicholson@hsc.utah.edu
      • Principal Investigator: Lowell Nicholson, MD
      • Sub-Investigator: Jamie Rhoads, MD
      • Sub-Investigator: Stephanie Klein, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPV Vaccine; 0.5-mL suspension of 9-valent Gardasil vaccine administered as intramuscular injection at weeks 0, 4, and 20	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 Names: Gardasil 9; 9-valent Gardasil
Placebo Comparator: Placebo; 0.5-mL normal saline 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 24 weeks	Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts, classified as: (1) complete response (CR; complete clearance of warts); (2) partial response (PR; any decrease in lesion number or size); or (3) no response (NR; no change or increase in lesion number or size)	Response to treatment assessments will occur 24 weeks after first dose of vaccine/placebo (primary endpoint)
Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 4 weeks	Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts, classified as: (1) complete response (CR; complete clearance of warts); (2) partial response (PR; any decrease in lesion number or size); or (3) no response (NR; no change or increase in lesion number or size)	Response to treatment assessments will occur 4 weeks after first dose of vaccine/placebo
Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 8 weeks	Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts, classified as: (1) complete response (CR; complete clearance of warts); (2) partial response (PR; any decrease in lesion number or size); or (3) no response (NR; no change or increase in lesion number or size)	Response to treatment assessments will occur at 8 weeks after first dose of vaccine/placebo

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skindex-16	Assessing for changes in quality of life, as indicated by the Skindex-16 questionnaire	Quality of life assessments will occur at 0 (baseline), 4, 8, and 24 weeks (primary endpoint)
Incidence of Treatment-Emergent Adverse Events	Assessing the safety and tolerability of HPV vaccination via adverse event reporting	Safety assessment will occur at 0, 4, 8, 20, and 24 weeks

Collaborators and Investigators

• Sponsor: Western Institute for Veterans Research
• Collaborators: Merck Sharp & Dohme LLC; University of Utah
• Investigators: Principal Investigator: Lowell Nicholson, MD, University of Utah Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: HPV vaccine; Refractory cutaneous warts; Human Papillomavirus (HPV) Vaccination
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: IRB_00152954

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No