Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts
- Conditions
- WartsHuman Papilloma Virus
- Interventions
- Biological: Candida antigen vaccineBiological: Bivalent HPV vaccine
- Registration Number
- NCT05291845
- Lead Sponsor
- Zagazig University
- 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: 18 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: 18 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: 18 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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
- Pregnant female. Hypersensitivity to Candida antigen or bivalent HPV vaccine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Candida antigen group Candida antigen vaccine 25 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. both agents group Bivalent HPV vaccine 25 patients will be treated with Both agents at the same session. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. Bivalent HPV vaccine Bivalent HPV vaccine 25 patients will be treated with the Bivalent HPV vaccine. All patients will be directly injected with the vaccine 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. both agents group Candida antigen vaccine 25 patients will be treated with Both agents at the same session. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. Candida antigen group Candida antigen vaccine 18 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. Bivalent HPV vaccine Bivalent HPV vaccine 18 patients will be treated with the Bivalent HPV vaccine. All patients will be directly injected with the vaccine 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. both agents group Candida antigen vaccine 18 patients will be treated with Both agents at the same session. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. both agents group Bivalent HPV vaccine 18 patients will be treated with Both agents at the same session. Injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method recurrence rate after recovery follow up for 6 months after recovery appearance of new lesions or recurrence of previous one
Trial Locations
- Locations (1)
Reham Essam
🇪🇬Zagazig, Al Sharqia, Egypt