Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts
1 other identifier
interventional
120
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2022
CompletedFirst Posted
Study publicly available on registry
November 23, 2022
CompletedStudy Start
First participant enrolled
March 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedApril 5, 2024
April 1, 2024
1.7 years
November 7, 2022
April 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Skindex-16
Quality of life assessments will occur at 0 (baseline), 4, 8, and 24 weeks (primary endpoint)
Incidence of Treatment-Emergent Adverse Events
Safety assessment will occur at 0, 4, 8, 20, and 24 weeks
Study Arms (2)
HPV Vaccine
EXPERIMENTAL0.5-mL suspension of 9-valent Gardasil vaccine administered as intramuscular injection at weeks 0, 4, and 20
Placebo
PLACEBO COMPARATOR0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20
Interventions
0.5-mL suspension of 9-valent Gardasil administered as intramuscular injection at weeks 0, 4, and 20
0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Western Institute for Veterans Researchlead
- University of Utahcollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (2)
University of Utah Midvalley Health Center
Salt Lake City, Utah, 84107, United States
VA Salt Lake City Health Care System
Salt Lake City, Utah, 84148, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lowell Nicholson, MD
University of Utah Health Care System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Investigators and Nurses share the role as Care Provider. Investigators will be blinded to the treatment allocation. Nurses, however, will be aware of the treatment allocation as they are administering the injections. Nurses are not involved in the study conduct in any other way.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2022
First Posted
November 23, 2022
Study Start
March 25, 2024
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
April 5, 2024
Record last verified: 2024-04