NCT07806617 Intralesional Gardasil-9 for the Treatment of Recalcitrant Warts
| NCT ID | NCT07806617 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rush University Medical Center |
| Condition | Warts |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2025-09-02 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 55 participants in total. It began in 2025-09-02 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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, active TB - latent or previous history of these would not exclude patients) * Previous severe reaction to HPV vaccination or known allergy to any vaccine component.
Frequently Asked Questions
Who can join the NCT07806617 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Warts. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07806617 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07806617 currently recruiting?
Yes, NCT07806617 is actively recruiting participants. Visit ClinicalTrials.gov or contact Rush University Medical Center to inquire about joining.
Where is the NCT07806617 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07806617 clinical trial?
NCT07806617 is sponsored by Rush University Medical Center. The trial plans to enroll 55 participants.