A Phase 2 interventional study of 9-valent human papillomavirus vaccine and Sterile Saline in Warts, Verruca (Warts) and Verruca Vulgaris, sponsored by Rush University Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Rush University Medical Center · Phase 2, Interventional, and Treatment
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 resolve after two standard therapies. Examples of prior therapies may include cryotherapy, electrodesiccation, salicylic acid, or over-the-counter treatments. Participants must be healthy and not immunocompromised. Participants will be randomized in a 2:1 ratio to receive either intralesional Gardasil-9 or sterile saline placebo. Two-thirds of participants will be assigned to Gardasil-9 and one-third will be assigned to placebo. The study coordinator will prepare the assigned treatment in a separate location so that both the participant and the clinician administering the injection remain blinded to treatment assignment. At the initial treatment visit, study investigators will confirm that the participant has at least one wart that has failed two or more previous treatments. Photographs will be taken to document the participant's warts before treatment. Participants will also complete the Dermatology Life Quality Index (DLQI) to assess the impact of their skin condition on their quality of life. The participant may select the wart or warts to be treated, and up to three warts may be injected during a treatment visit. The study clinician will inject the assigned study treatment, either Gardasil-9 or sterile saline, directly into the selected wart or warts. Participants may elect to receive lidocaine for local anesthesia prior to administration of the study treatment. Following treatment, a member of the study team will contact the participant within approximately one week to assess any reported changes to the treated wart or warts or any new reactions. Participants will return for an in-person follow-up visit approximately 4-6 weeks after treatment. At the follow-up visit, photographs will again be taken to document the warts. If the treated wart or warts have not resolved or have only partially resolved, additional treatment may be administered. Participants will return approximately 4-6 weeks later for further evaluation and may receive a third treatment if the wart or warts have not resolved. At the completion of the blinded treatment period, participants will complete the DLQI again and will be informed whether they received Gardasil-9 or sterile saline. After completion of the blinded portion of the study, participants who were assigned to sterile saline will have the opportunity to receive intralesional Gardasil-9 during an open-label extension. Participants initially assigned to Gardasil-9 whose warts have not completely cleared after the initial treatment period may also continue to receive additional Gardasil-9 injections during the open-label extension. Participants may receive up to six total treatments at approximately 4-6 week intervals as part of the study and open-label extension.
171 studies on the registry are indexed under Warts; 35 are open to participants now.
This study's planned enrollment of 55 is below the median of 70 across 155 interventional studies indexed under Warts.
Browse Warts studies →Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
cryotherapy, electrodesiccation, keratolytic agents, bleomycin, salicylic acid, excision.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: 9-valent human papillomavirus vaccine
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.
Other: Sterile Saline
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.
Also known as: Gardasil-9
Sterile saline administered by intralesional injection as the placebo comparator during the double-blind treatment period.
Also known as: placebo
Clearance of the Target Wart After Intralesional Gardasil-9 Treatment
Clinical response of the target wart will be assessed using standardized photographs obtained before and after treatment. Short and long diameters of the wart will be measured from digital photographs, and changes in lesion area will be evaluated. Clinical response will also be assessed using the Physician Global Assessment (PGA) scale, ranging from 0 (complete response) to 4 (poor response), based on percentage improvement.
Time frame: Baseline through 12-14 weeks
Incidence and Severity of Treatment-Related Adverse Reactions
Safety will be assessed by documenting adverse reactions following intralesional treatment. Adverse reactions will be classified as mild, moderate, or severe based on their impact on participants' daily functioning and the need for clinician intervention.
Time frame: From first treatment through 12-14 weeks
Change in Dermatology Life Quality Index (DLQI) Score
Change in Dermatology Life Quality Index (DLQI) score from baseline to completion of treatment. The DLQI is a 10-item questionnaire with a total score ranging from 0 to 30. Higher scores indicate greater impairment in dermatology-related quality of life, while lower scores indicate less impairment. The DLQI is administered before the first intralesional injection and again after completion of treatment to assess the impact of the participant's skin condition on quality of life.
Time frame: Baseline through completion of treatment
Clinical Response of Non-Injected Warts
Clinical response of warts that were not directly injected will be evaluated using standardized photographs. Short and long diameters of non-injected lesions will be measured to assess changes following treatment.
Time frame: Baseline through 12-14 weeks
Plan to share: No — De-identified individual participant data collected during this study are not planned to be shared with researchers outside the primary research group.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Human Papillomavirus Recombinant Vaccine nonavalent
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