NCT05383625

Gardasil Versus Cervarix in the Treatment of Warts

Quadrivalent and Bivalent Human Papilloma Virus Vaccines in the Treatment of Common Recalcitrant Warts

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Warts are common, benign, epidermal proliferations caused by HPV infecting skin and mucous membranes. Treatment of warts poses a true challenge despite existing variable therapeutic modalities, whether destructive or immunotherapeutic. Human papilloma virus (HPV) vaccines are FDA approved for the prevention of genital warts and wart related precancerous and cancerous lesions but they are not indicated for treatment of preexisting warts yet

Detailed description

Approximately 35% of viral warts tend to be recalcitrant either showing no response to treatment or having prompt recurrences after treatment, causing frustration for both patients and physicians. Success rates vary significantly across patients and across different therapeutic interventions ranging from 7% to 90%. Immunotherapy is proposed to enhance virus recognition by the cell mediated immunity, which allows the clearance of both treated and untreated warts and helps to prevent recurrences through induction of a long-term acquired immunity to HPV. Few reports suggest the possibility of using quadrivalent or bivalent HPV vaccines as therapeutic modality rather than only preventive modality. This is a randomized controlled study to assess the efficacy and safety of quadrivalent and bivalent HPV vaccines in the treatment of warts

Conditions

• Verruca Viral

Interventions

Type	Name	Description
DRUG	Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine	intralesional 0.1 ml every two weeks
DRUG	Bivalent Human Papilloma Virus Vaccine	Intralesional 0.1 ml every two weeks
DRUG	Saline	intralesional into the largest warts every two weeks

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-10-01
• Completion: 2021-12-01
• First posted: 2022-05-20
• Last updated: 2022-05-20

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study