WartsPhase 2NCT07806617
Intralesional Gardasil-9 for the Treatment of Recalcitrant Warts
A Phase 2 study testing 9-valent human papillomavirus vaccine and Sterile Saline in people with Warts and Verruca (Warts), run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Warts, Verruca (Warts), Verruca Vulgaris
- What is being tested?
- 9-valent human papillomavirus vaccine and Sterile Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Immunocompetent (no history of organ transplantation, active malignancy requiring immunosuppressive therapy, or HIV (human immunodeficiency virus) positive status)
- At least one wart that has been refractory to treatment
- At least two treatment modalities failed, including but not limited to:
- cryotherapy, electrodesiccation, keratolytic agents, bleomycin, salicylic acid, excision.
Who cannot join
- Unable to provide informed consent.
- Younger than 18 years of age.
- Pregnant.
- Prisoner.
- Vulnerable populations, including immunocompromised status (active cancer, active tuberculosis (TB) - latent or previous history of these would not exclude patients)
- Previous severe reaction to HPV vaccination or known allergy to any vaccine component.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Intralesional Gardasil-9 Vaccine for the Treatment of Recalcitrant Verrucae
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.
Read the detailed description
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.
- Conditions
- Warts, Verruca (Warts), Verruca Vulgaris
- Being tested
- 9-valent human papillomavirus vaccine, Sterile Saline
- Keywords
- Recalcitrant Warts, Recalcitrant Verrucae, Verruca Vulgaris, Human Papillomavirus, Gardasil-9, Intralesional Immunotherapy, Intralesional HPV Vaccine, HPV
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9-valent human papillomavirus vaccineBiological
Also called Gardasil-9
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 SalineOther
Also called placebo
Sterile saline administered by intralesional injection as the placebo comparator during the double-blind treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Intralesional Gardasil-9 | Experimental | 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. Receives: Biological: 9-valent human papillomavirus vaccine |
| Intralesional Sterile Saline Placebo | Placebo comparator | 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. Receives: Other: Sterile Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From first treatment through 12-14 weeks
Secondary outcomes (1)
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.
Measured: Baseline through completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start2 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for WartsStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to receive intralesional Gardasil-9 or sterile saline during the double-blind, placebo-controlled treatment period. Following completion of the blinded treatment period and disclosure of treatment assignment, eligible participants may receive intralesional Gardasil-9 during an open-label extension.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Department of Dermatology
- Responsible party
- Principal investigator, David Christopher Reid, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806617
- Sponsor's protocol ID
- ORA#: 25042701-IRB01
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data collected during this study are not planned to be shared with researchers outside the primary research group.
Publications
Kumar, S., Singh, O., Brar, S. K. & Gill, S. K. (2021). Efficacy and safety of intralesional quadrivalent human papillomavirus vaccine as immunotherapy in management of recalcitrant genital warts in a tertiary health care center of North India. National Journal of Physiology, Pharmacy and Pharmacology, 11 (5), 540-543. doi:10.5455/njppp.2021.11.03083202115032021
Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
PubMed 8033378Adusumilli N, Shoen E, Friedman A. Psychosocial Burden of Verruca Vulgaris: A Cross-Sectional Survey. J Drugs Dermatol. 2022 Jun 1;21(6):614-617. doi: 10.36849/JDD.6773.
PubMed 35674752Scarbrough Lefebvre CD, Van Kriekinge G, Goncalves MA, de Sanjose S. Appraisal of the burden of genital warts from a healthcare and individual patient perspective. Public Health. 2011 Jul;125(7):464-75. doi: 10.1016/j.puhe.2011.01.016. Epub 2011 Jun 30.
PubMed 21722930Forman D, de Martel C, Lacey CJ, Soerjomataram I, Lortet-Tieulent J, Bruni L, Vignat J, Ferlay J, Bray F, Plummer M, Franceschi S. Global burden of human papillomavirus and related diseases. Vaccine. 2012 Nov 20;30 Suppl 5:F12-23. doi: 10.1016/j.vaccine.2012.07.055.
PubMed 23199955Lawrence S, Walzman M, Sheppard S, Natin D. The psychological impact caused by genital warts: has the Department of Health's choice of vaccination missed the opportunity to prevent such morbidity? Int J STD AIDS. 2009 Oct;20(10):696-700. doi: 10.1258/ijsa.2009.009120.
PubMed 19815914Qi SZ, Wang SM, Shi JF, Wang QQ, Chen XS, Sun LJ, Liu A, Zhang N, Jiang N, Siva P, Xu XL, Qiao YL. Human papillomavirus-related psychosocial impact of patients with genital warts in China: a hospital-based cross-sectional study. BMC Public Health. 2014 Jul 21;14:739. doi: 10.1186/1471-2458-14-739.
PubMed 25048000Jiang F, Shao J, Chen L, Yang N, Liu J, Li Z. Successful treatment of periungual warts with local hyperthermia: report of two cases. J Dermatolog Treat. 2022 Jun;33(4):2380-2382. doi: 10.1080/09546634.2021.1961995. Epub 2021 Aug 1.
PubMed 34334094Phan K, Lin MJ. Intralesional Human Papillomavirus Vaccine Therapy for Recalcitrant Plantar Wart Triggers Gout Flare. Cutis. 2022 Aug;110(2):E13-E14. doi: 10.12788/cutis.0595. No abstract available.
PubMed 36219651Moore AY. Clinical applications for topical 5-fluorouracil in the treatment of dermatological disorders. J Dermatolog Treat. 2009;20(6):328-35. doi: 10.3109/09546630902789326.
PubMed 19954388Batista CS, Atallah AN, Saconato H, da Silva EM. 5-FU for genital warts in non-immunocompromised individuals. Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD006562. doi: 10.1002/14651858.CD006562.pub2.
PubMed 20393949Ulschmid CM, Patel J, Pan AY, Liegl M, Holland KE. Intralesional measles, mumps, and rubella vaccine after failure of intralesional Candida antigen for the treatment of recalcitrant pediatric warts. Pediatr Dermatol. 2023 Nov-Dec;40(6):1057-1059. doi: 10.1111/pde.15415. Epub 2023 Aug 19.
PubMed 37596908Nofal A, Adel L, Fawzy M, Elkholy BM. Intralesional immunotherapy for multiple recalcitrant plantar warts: Candida antigen is superior to intralesional purified protein derivative. Dermatol Ther. 2022 Jun;35(6):e15440. doi: 10.1111/dth.15440. Epub 2022 Apr 9.
PubMed 35285995Mohammed GF, Al-Dhubaibi MS, Bahaj SS, Elneam AIA. Systemic immunotherapy for the treatment of warts: A literature review. J Cosmet Dermatol. 2022 Nov;21(11):5532-5536. doi: 10.1111/jocd.15330. Epub 2022 Aug 31.
PubMed 36017650Balague N, Vostrel P, Beaulieu JY, van Aaken J. Third degree formic acid chemical burn in the treatment of a hand wart: a case report and review of the literature. Springerplus. 2014 Aug 5;3:408. doi: 10.1186/2193-1801-3-408. eCollection 2014.
PubMed 25140289
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of Intralesional Gardasil-9 Vaccine for the Treatment of Recalcitrant Verrucae
- ClinicalTrials.gov ID
- NCT07806617
- Acronym / sponsor ID
- ORA#: 25042701-IRB01
- Conditions
- Warts, Verruca (Warts), Verruca Vulgaris
- Keywords
- Recalcitrant Warts, Recalcitrant Verrucae, Verruca Vulgaris, Human Papillomavirus, Gardasil-9, Intralesional Immunotherapy, Intralesional HPV Vaccine, HPV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Rush University Department of Dermatology
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants are randomized to receive intralesional Gardasil-9 or sterile saline during the double-blind, placebo-controlled treatment period. Following completion of the blinded treatment period and disclosure of treatment assignment, eligible participants may receive intralesional Gardasil-9 during an open-label extension.
| Arm | Type | Receives |
|---|---|---|
| Intralesional Gardasil-9 | Experimental | Biological: 9-valent human papillomavirus vaccineParticipants 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. |
| Intralesional Sterile Saline Placebo | Placebo comparator | Other: Sterile SalineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- Immunocompetent (no history of organ transplantation, active malignancy requiring immunosuppressive therapy, or HIV (human immunodeficiency virus) positive status)
- At least one wart that has been refractory to treatment
- At least two treatment modalities failed, including but not limited to:
- cryotherapy, electrodesiccation, keratolytic agents, bleomycin, salicylic acid, excision.
Key exclusion criteria (6 listed)
- Unable to provide informed consent.
- Younger than 18 years of age.
- Pregnant.
- Prisoner.
- Vulnerable populations, including immunocompromised status (active cancer, active tuberculosis (TB) - latent or previous history of these would not exclude patients)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9-valent human papillomavirus vaccineAlso: Gardasil-99-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. | Biological | Intralesional Gardasil-9 |
| Sterile SalineAlso: placeboSterile saline administered by intralesional injection as the placebo comparator during the double-blind treatment period. | Other | Intralesional Sterile Saline Placebo |
Primary outcome
Clearance of the Target Wart After Intralesional Gardasil-9 Treatment
Time frame: Baseline through 12-14 weeks
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.
Incidence and Severity of Treatment-Related Adverse Reactions
Time frame: From first treatment through 12-14 weeks
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.
1 secondary outcome
Change in Dermatology Life Quality Index (DLQI) Score
Time frame: Baseline through completion of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- BackgroundKumar, S., Singh, O., Brar, S. K. & Gill, S. K. (2021). Efficacy and safety of intralesional quadrivalent human papillomavirus vaccine as immunotherapy in management of recalcitrant genital warts in a tertiary health care center of North India. National Journal of Physiology, Pharmacy and Pharmacology, 11 (5), 540-543. doi:10.5455/njppp.2021.11.03083202115032021
- Background: PubMed 8033378Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
- Background: PubMed 35674752Adusumilli N, Shoen E, Friedman A. Psychosocial Burden of Verruca Vulgaris: A Cross-Sectional Survey. J Drugs Dermatol. 2022 Jun 1;21(6):614-617. doi: 10.36849/JDD.6773.
- Background: PubMed 21722930Scarbrough Lefebvre CD, Van Kriekinge G, Goncalves MA, de Sanjose S. Appraisal of the burden of genital warts from a healthcare and individual patient perspective. Public Health. 2011 Jul;125(7):464-75. doi: 10.1016/j.puhe.2011.01.016. Epub 2011 Jun 30.
- Background: PubMed 23199955Forman D, de Martel C, Lacey CJ, Soerjomataram I, Lortet-Tieulent J, Bruni L, Vignat J, Ferlay J, Bray F, Plummer M, Franceschi S. Global burden of human papillomavirus and related diseases. Vaccine. 2012 Nov 20;30 Suppl 5:F12-23. doi: 10.1016/j.vaccine.2012.07.055.
- Background: PubMed 19815914Lawrence S, Walzman M, Sheppard S, Natin D. The psychological impact caused by genital warts: has the Department of Health's choice of vaccination missed the opportunity to prevent such morbidity? Int J STD AIDS. 2009 Oct;20(10):696-700. doi: 10.1258/ijsa.2009.009120.
- Background: PubMed 25048000Qi SZ, Wang SM, Shi JF, Wang QQ, Chen XS, Sun LJ, Liu A, Zhang N, Jiang N, Siva P, Xu XL, Qiao YL. Human papillomavirus-related psychosocial impact of patients with genital warts in China: a hospital-based cross-sectional study. BMC Public Health. 2014 Jul 21;14:739. doi: 10.1186/1471-2458-14-739.
- Background: PubMed 34334094Jiang F, Shao J, Chen L, Yang N, Liu J, Li Z. Successful treatment of periungual warts with local hyperthermia: report of two cases. J Dermatolog Treat. 2022 Jun;33(4):2380-2382. doi: 10.1080/09546634.2021.1961995. Epub 2021 Aug 1.
- Background: PubMed 36219651Phan K, Lin MJ. Intralesional Human Papillomavirus Vaccine Therapy for Recalcitrant Plantar Wart Triggers Gout Flare. Cutis. 2022 Aug;110(2):E13-E14. doi: 10.12788/cutis.0595. No abstract available.
- Background: PubMed 19954388Moore AY. Clinical applications for topical 5-fluorouracil in the treatment of dermatological disorders. J Dermatolog Treat. 2009;20(6):328-35. doi: 10.3109/09546630902789326.
- Background: PubMed 20393949Batista CS, Atallah AN, Saconato H, da Silva EM. 5-FU for genital warts in non-immunocompromised individuals. Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD006562. doi: 10.1002/14651858.CD006562.pub2.
- Background: PubMed 37596908Ulschmid CM, Patel J, Pan AY, Liegl M, Holland KE. Intralesional measles, mumps, and rubella vaccine after failure of intralesional Candida antigen for the treatment of recalcitrant pediatric warts. Pediatr Dermatol. 2023 Nov-Dec;40(6):1057-1059. doi: 10.1111/pde.15415. Epub 2023 Aug 19.
- Individual participant dataSharing planned: No. De-identified individual participant data collected during this study are not planned to be shared with researchers outside the primary research group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 9-valent human papillomavirus vaccine and Sterile Saline in people with Warts and Verruca (Warts), run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance of the Target Wart After Intralesional Gardasil-9 Treatment (time frame: Baseline through 12-14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07806617, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.