Intralesional Gardasil-9 for the Treatment of Recalcitrant Warts

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.

Timeline

Start

2025-09-02

Primary completion

2027-06

Completion

2027-06

Publications

• Background 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
• Background 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.
• Background Adusumilli 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 Scarbrough 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 Forman 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 Lawrence 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 Qi 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 Jiang 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 Phan 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 Moore 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 Batista 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 Ulschmid 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.
• Background Nofal 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.
• Background Mohammed 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.
• Background Balague 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.
• Background Nofal A, Nofal H, Alwirshiffani E, ElGhareeb MI. Treatment response and tolerability of intralesional quadrivalent versus bivalent human papillomavirus vaccine for recalcitrant warts: A randomized controlled trial. J Am Acad Dermatol. 2023 Nov;89(5):1051-1052. doi: 10.1016/j.jaad.2023.06.042. Epub 2023 Jul 6. No abstract available.
• Background Thomas R, Smith-Matthews S, Ho J. Giant condyloma of Buschke-Lowenstein in a patient with pemphigus vegetans treated with intralesional and systemic human papillomavirus vaccine. JAAD Case Rep. 2021 Dec 29;20:54-57. doi: 10.1016/j.jdcr.2021.12.024. eCollection 2022 Feb. No abstract available.
• Background Coordes A, Grund D, Mainka A, Olze H, Hanitsch L, von Bernuth H, Dommerich S. [Recurrent laryngeal papillomatosis]. HNO. 2023 Feb;71(2):77-82. doi: 10.1007/s00106-022-01250-1. Epub 2022 Dec 7. German.
• Background Bar-Ilan E, Bar J, Baniel A, Slodownik D, Artzi O, Samuelov L, Sprecher E, Mashiah J. Intralesional human papillomavirus vaccine for the treatment of recalcitrant cutaneous warts. J Dermatol. 2023 Nov;50(11):1373-1380. doi: 10.1111/1346-8138.16905. Epub 2023 Jul 27.
• Background Williamson AL. Recent Developments in Human Papillomavirus (HPV) Vaccinology. Viruses. 2023 Jun 26;15(7):1440. doi: 10.3390/v15071440.
• Background de Martel C, Plummer M, Vignat J, Franceschi S. Worldwide burden of cancer attributable to HPV by site, country and HPV type. Int J Cancer. 2017 Aug 15;141(4):664-670. doi: 10.1002/ijc.30716. Epub 2017 Jun 8.
• Background Serrano B, Brotons M, Bosch FX, Bruni L. Epidemiology and burden of HPV-related disease. Best Pract Res Clin Obstet Gynaecol. 2018 Feb;47:14-26. doi: 10.1016/j.bpobgyn.2017.08.006. Epub 2017 Sep 2.
• Background Salman S, Ahmed MS, Ibrahim AM, Mattar OM, El-Shirbiny H, Sarsik S, Afifi AM, Anis RM, Yakoub Agha NA, Abushouk AI. Intralesional immunotherapy for the treatment of warts: A network meta-analysis. J Am Acad Dermatol. 2019 Apr;80(4):922-930.e4. doi: 10.1016/j.jaad.2018.07.003. Epub 2018 Jul 10.

Drugs

Indications