Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Candida antigen vaccine, Bivalent HPV vaccine.
- Who it may be relevant to
- Registry conditions: Warts, Human Papilloma Virus. Basic parameters: from 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts: Monotherapy Versus Combined Therapy
Overview
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
- Biological Candida 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 - Biological Bivalent 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
Primary outcome measures
- complete response [Time frame: upto 3 months]
- partial response [Time frame: upto 3 months]
- no response [Time frame: upto 3 months]
Secondary outcome measures (1)
- recurrence rate after recovery [Time frame: follow up for 6 months after recovery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Reham Essam — Zagazig
Publications
- Nofal A, Marei A, Ibrahim AM, Nofal E, Nabil M. Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts. J Am Acad Dermatol. 2020 Jan;82(1):94-100. doi: 10.1016/j.jaad.2019.07.070. Epub 2019 Jul 29. PMID 31369771
- Nassar A, Alakad R, Essam R, Bakr NM, Nofal A. Comparative efficacy of intralesional Candida antigen, intralesional bivalent human papilloma virus vaccine, and cryotherapy in the treatment of common warts. J Am Acad Dermatol. 2022 Aug;87(2):419-421. doi: 10.1016/j.jaad.2021.08.040. Epub 2021 Aug 28. No abstract available. PMID 34464624
Identifiers
NCT: NCT05291845 · C.ag-vs-B.HPV.V