Clinical trial · Interventional
Intralesional Gardasil-9 for the Treatment of Recalcitrant Warts
A Randomized, Double-Blind, Placebo-Controlled Trial of Intralesional Gardasil-9 Vaccine for the Treatment of Recalcitrant Verrucae
NCT07806617CI-TRIAL-00126132active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Verruca Vulgaris | Verruca Vulgaris | ONTOLOGY_EXACT | 0.98 |
| Verruca (Warts) | Verrucous Lesion | ALIAS | 0.85 |
| Warts | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 9-valent human papillomavirus vaccine | Biological | — | UNRESOLVED |
| Sterile Saline | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intralesional Gardasil-9
- description
- 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.
- interventionNames
- Biological: 9-valent human papillomavirus vaccine
- type
- PLACEBO_COMPARATOR
- label
- Intralesional Sterile Saline Placebo
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (23)
- 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
- BACKGROUNDFinlay 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. PMID 8033378
- BACKGROUNDAdusumilli 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. PMID 35674752
- BACKGROUNDScarbrough 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. PMID 21722930
- BACKGROUNDForman 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. PMID 23199955
- BACKGROUNDLawrence 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. PMID 19815914
- BACKGROUNDQi 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.