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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Western Institute for Veterans Research
Study ID
NCT05625633
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Warts

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 25, 2024
Status verified
Apr 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HPV Vaccine
    0.5-mL suspension of 9-valent Gardasil vaccine administered as intramuscular injection at weeks 0, 4, and 20
  • Placebo Comparator: Placebo
    0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20

Primary Outcome Measure

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 [ Time Frame: Response to treatment assessments will occur 24 weeks after first dose of vaccine/placebo (primary endpoint) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Utah Midvalley Health CenterSalt Lake CityUtah84107
Lowell Nicholson, MD
[email protected]
801-581-2121
Lowell Nicholson, MD (PRINCIPAL_INVESTIGATOR)
Jamie Rhoads, MD (SUB_INVESTIGATOR)
Stephanie Klein, MD (SUB_INVESTIGATOR)
VA Salt Lake City Health Care SystemSalt Lake CityUtah84148
Jamie Rhoads, MD
[email protected]
801-582-1565
Jamie Rhoads, MD (PRINCIPAL_INVESTIGATOR)
Lowell Nicholson, MD (SUB_INVESTIGATOR)
Stephanie Klein, MD (SUB_INVESTIGATOR)

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By research site
University of Utah Midvalley Health Center· Salt Lake City, UTVA Salt Lake City Health Care System· Salt Lake City, UT

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