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Intralesional Gardasil-9 for the Treatment of Recalcitrant Warts
Sponsor: Rush University Medical Center
Summary
This study will evaluate whether Gardasil-9, a vaccine normally used to prevent human papillomavirus (HPV) infection, may be effective for treating recurring warts that have not responded to standard treatments. In this study, Gardasil-9 will be injected directly into a wart rather than into a muscle, which is an investigational use of the vaccine. Participants will be randomly assigned to receive injections of either Gardasil-9 or sterile saline (placebo) directly into a wart. Neither the participant nor the clinician administering the injection will know which treatment is being given. The study will evaluate participants during treatment and follow-up visits to assess their warts and quality of life.
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Intralesional Gardasil-9 Vaccine for the Treatment of Recalcitrant Verrucae
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2025-09-02
Completion Date
2027-06
Last Updated
2026-09-08
Healthy Volunteers
No
Conditions
Interventions
9-valent human papillomavirus vaccine
9-valent human papillomavirus (HPV) vaccine administered by intralesional injection directly into the selected wart or warts. Up to three warts may be treated during a treatment visit. Participants may receive additional treatments at approximately 4-6 week intervals if the treated wart or warts have not resolved. Participants may elect to receive lidocaine for local anesthesia prior to administration of the study intervention.
Sterile Saline
Sterile saline administered by intralesional injection as the placebo comparator during the double-blind treatment period.
Locations (1)
Rush University Medical Center
Chicago, Illinois, United States