Human Papilloma Virus, Warts
Conditions
Brief summary
To follow up the efficacy and safety of Candida antigen, bivalent HPV vaccine in treatment of common warts either mono or combined intralesional therapy
Detailed description
* Group A: 54 patients will be treated with Candida antigen. All patients will be directly injected with Candida antigen into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. * Group B: 54 patients will be treated with bivalent HPV vaccine solution intralesional into the largest wart using an insulin syringe. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. * Group C: 54 patients will be treated with both agents intralesionally into the largest wart using an insulin syringe at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. it is thought that candida antigen act through a cell-mediated immune response and bivalent HPV vaccine act mainly through humoral immunity, so we want to study their effect as single or mixed agents
Interventions
BIOLOGICALCandida antigen vaccine
we will study the efficacy and safety of agent in the treatment of multiple warts, we will follow up the recurrence rate of each group
BIOLOGICALBivalent HPV vaccine
we will study the efficacy and safety of agent in the treatment of multiple warts, we will follow up the recurrence rate of each group
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with multiple, recalcitrant, or non-recalcitrant common warts of different sites, sizes, duration, and with or without distant lesions will be enrolled in the study
Exclusion criteria
* Pregnant female. Hypersensitivity to Candida antigen or bivalent HPV vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete response | upto 3 months | if there is disappearance of warts and return of the normal skin markings |
| partial response | upto 3 months | if warts regressed in size by 50-99% (the size will be measured as the summation of size of all lesions in cm) |
| no response | upto 3 months | if there is \< 50% decrease in wart size. (the size will be measured as the summation of size of all lesions in cm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recurrence rate after recovery | follow up for 6 months after recovery | appearance of new lesions or recurrence of previous one |
Countries
Egypt
Contacts
Primary ContactReham Essam, MD
Backup ContactReham Essam, MD
Outcome results
None listed