Human Papillomavirus (HPV) Vaccination for the Treatment of Refractory Cutaneous Warts: A Randomized, Placebo-Controlled, Double-Blinded Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.)
Locations
United States
Utah
University of Utah Midvalley Health Center
RECRUITING
Salt Lake City
VA Salt Lake City Health Care System
RECRUITING
Salt Lake City
Contact Information
Primary
Lowell Nicholson, MD
lowell.nicholson@hsc.utah.edu
801-581-2121
Backup
Jamie Rhoads, MD
jamie.rhoads@hsc.utah.edu
801-581-2121
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2026-12
Participants
Target number of participants: 120
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC, University of Utah
Leads: Western Institute for Veterans Research