A Phase 3 interventional study of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine and Bivalent Human Papilloma Virus Vaccine in Verruca Viral, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by Zagazig University · Phase 3, Interventional, and Treatment
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
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
180 studies on the registry are indexed under Warts; 28 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 159 interventional studies indexed under Warts.
Browse Warts studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who do not receive any treatment of warts for at least 1 month before the start of study.
Exclusion Criteria:
Pregnancy or lactation
Patient receive 0.1 ml of quadrivalent HPV vaccine intralesional every two weeks
Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Patient received 0.1 ml of bivalent HPV vaccine intralesional once every two weeks
Drug: Bivalent Human Papilloma Virus Vaccine
Patient received 0.1 ml of intralesional saline once every two weeks
Drug: Saline
intralesional 0.1 ml every two weeks
Intralesional 0.1 ml every two weeks
intralesional into the largest warts every two weeks
Therapeutic response
The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions
Time frame: Through study completion for a maximum of 12 weeks, evaluation held at two weeks interval and at the end of treatment sessions (12th week visit)
Safety measure
Immediate adverse events recorded by the treating physician within 1 hour post injection
Time frame: Through study completion every treatment session held at two weeks interval for a maximum of 5 sessions
Safety measure
Delayed adverse events reported by the patients in between sessions
Time frame: Through study completion for a maximum of 12 weeks held every two weeks till the end of the treatment sessions (12th week visit)
Recurrence
Percentage of patients experiencing recurrences in each group
Time frame: 6 months following the end of treatment sessions
Plan to share: Yes
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Zagazig University