Verruca Viral
Conditions
Brief 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
Interventions
intralesional 0.1 ml every two weeks
DRUGBivalent Human Papilloma Virus Vaccine
Intralesional 0.1 ml every two weeks
DRUGSaline
intralesional into the largest warts every two weeks
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult Patients with recalcitrant multiple warts of any type. Warts were considered recalcitrant if they persisted for at least 6 months without any response to 2 different therapeutic modalities or more. * Immunocompetent patients. * Patients who do not receive any treatment of warts for at least 1 month before the start of study. * Patients who are able to understand and follow the study protocol and approve to sign the informed consent
Exclusion criteria
* Patients with acute febrile illness. * Past history of asthma. * Allergic skin disorders, such as generalized eczema, or severe urticaria. * Pregnancy or lactation * History of hypersensitivity to the treatment vaccines. * Children * Immunocompromised patients * Patients unable to follow the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic response | 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) | The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety measure | Through study completion every treatment session held at two weeks interval for a maximum of 5 sessions | Immediate adverse events recorded by the treating physician within 1 hour post injection |
| Recurrence | 6 months following the end of treatment sessions | Percentage of patients experiencing recurrences in each group |
Countries
Egypt
Outcome results
None listed