Clinical trial NCT05291845: Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts
Official title: Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts: Monotherapy Versus Combined Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Warts
Human Papilloma Virus
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-03-23
Enrollment: 162
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: complete response
timeFrame: upto 3 months
measure: partial response
timeFrame: upto 3 months
measure: no response
timeFrame: upto 3 months
Secondary outcomes:
measure: recurrence rate after recovery
timeFrame: follow up for 6 months after recovery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Reham Essam
state: Al Sharqia
Study officials:
affiliation: Zagazig University
name: Reham Essam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zagazig University
name: Ahmad Nofal, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.