Intralesional Gardasil-9 for the Treatment of Recalcitrant Warts

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT07806617
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Verruca (Warts)
  • Verruca Vulgaris
  • Warts

Eligibility Criteria

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

Interventions

  • 9-valent human papillomavirus vaccine — BIOLOGICAL
    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 — OTHER
    Sterile saline administered by intralesional injection as the placebo comparator during the double-blind treatment period.

Study Details

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.

Key Dates

First listed
Sep 8, 2026
Start date
Sep 2, 2025
Status verified
Sep 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: Intralesional Gardasil-9
    Participants randomized to this arm will receive 9-valent human papillomavirus (HPV) vaccine (Gardasil-9) administered by intralesional injection into the selected wart or warts. Up to three warts may be treated during a treatment visit. Participants will return approximately every 4-6 weeks for evaluation and may receive additional treatment if the treated wart or warts have not resolved.
  • Placebo Comparator: Intralesional Sterile Saline Placebo
    Participants randomized to this arm will receive sterile saline administered by intralesional injection as the placebo comparator. Participants will return approximately every 4-6 weeks for evaluation and may receive additional blinded treatment if the treated wart or warts have not resolved. After completion of the blinded study period and disclosure of treatment assignment, participants who received sterile saline will have the option to receive intralesional Gardasil-9 during the open-label extension.

Primary Outcome Measure

Clearance of the Target Wart After Intralesional Gardasil-9 Treatment [ Time Frame: Baseline through 12-14 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
David C Reid, MD
[email protected]
(312) 942-2195
David C Reid, MD (PRINCIPAL_INVESTIGATOR)

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Rush University Medical Center· Chicago, IL

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