Rush University Medical Center
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.
This is a randomized, double-blind, placebo-controlled study evaluating the use of intralesional Gardasil-9 for the treatment of recalcitrant verrucae. Gardasil-9 is approved by the U.S. Food and Drug Administration (FDA) for the prevention of disease caused by certain types of human papillomavirus (HPV) and is typically administered by intramuscular injection. In this study, Gardasil-9 will be injected directly into warts as an investigational treatment for warts that have not responded to standard therapies. Eligible participants will be adults with at least one wart that has failed to reso…
Inclusion Criteria: * Age 18 years or older. * Immunocompetent (no history of organ transplantation, active malignancy requiring immunosuppressive therapy, or HIV positive status) * At least one wart that has been refractory to treatment * At least two treatment modalities failed, including but not limited to: cryotherapy, electrodessication, keratolytic agents, bleomycin, salicylic acid, excision. Exclusion Criteria: * Unable to provide informed consent. * Younger than 18 years of age. * Pregnant. * Prisoner. * Vulnerable populations, including immunocompromised status (active cancer, act…
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 administered by intralesional injection as the placebo comparator during the double-blind treatment period.
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