Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts

Study Overview
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Brief Summary
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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
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Group A: 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. Group B: 25 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: 25 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

Official Title
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Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts: Monotherapy Versus Combined Therapy

Conditions
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Warts, Human Papilloma Virus

Intervention / Treatment
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* Biological: Candida antigen vaccine
* Biological: Bivalent HPV vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Candida antigen group<br>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. | Biological: Candida antigen vaccine<br>* 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<br>|
| Experimental: Bivalent HPV vaccine<br>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. | Biological: Bivalent HPV vaccine<br>* 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<br>|
| Experimental: both agents group<br>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. | Biological: Candida antigen vaccine<br>* 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<br>Biological: Bivalent HPV vaccine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response | if there is disappearance of warts and return of the normal skin markings | upto 3 months | 
| partial response | if warts regressed in size by 50-99% (the size will be measured as the summation of size of all lesions in cm) | upto 3 months | 
| no response | if there is < 50% decrease in wart size. (the size will be measured as the summation of size of all lesions in cm) | upto 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate after recovery | appearance of new lesions or recurrence of previous one | follow up for 6 months after recovery |