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NCT Number: NCT05291845

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

To follow up the efficacy and safety of Candida antigen, bivalent HPV vaccine in treatment of common warts either mono or combined intralesional therapy

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Key information

Conditions

Warts DNA Virus Infections Human Papilloma Virus Infections Papillomavirus Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Virus Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Candida antigen vaccine

Biological

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

Bivalent HPV vaccine

Biological

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 outcomes

  1. complete response

    Time frame: upto 3 months

    if there is disappearance of warts and return of the normal skin markings

  2. partial response

    Time frame: 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)

  3. no response

    Time frame: 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 outcomes

  1. recurrence rate after recovery

    Time frame: follow up for 6 months after recovery

    appearance of new lesions or recurrence of previous one

Study contacts

Contact information is provided by the study sponsor or research team.

Reham Essam, MD

CONTACT

[email protected]

+201097709477

Reham Essam, MD

CONTACT

[email protected]

+201097709477

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 23, 2022
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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