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

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

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

Study Overview

• Status: Recruiting
• Conditions: Warts; Human Papilloma Virus
• Intervention / Treatment: Biological: Candida antigen vaccine; Biological: Bivalent HPV vaccine

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

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Reham Essam, MD; Phone Number: +201097709477; Email: rekfarid@medicine.zu.edu.eg
• Study Contact Backup: Name: Reham Essam, MD; Phone Number: +201097709477; Email: rereessam22@gmail.com

Study Locations

• Egypt
  • Al Sharqia
    • Zagazig, Al Sharqia, Egypt, 2543
      • Recruiting
      • Reham Essam
      • Contact: Reham Essam; Phone Number: 01097709477; Email: rereessam22@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Candida antigen group; 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.	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
Experimental: Bivalent HPV vaccine; 54 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; 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
Experimental: both agents group; 54 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Study Director: Ahmad Nofal, MD, Zagazig University; Principal Investigator: Reham Essam, MD, Zagazig University

Publications and helpful links

General 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.
• 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.

Helpful Links

• Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts
• Comparative efficacy of intralesional Candida antigen, intralesional bivalent human papilloma virus vaccine, and cryotherapy in the treatment of common warts

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2022
• Primary Completion (Estimated): October 3, 2025
• Study Completion (Estimated): December 6, 2025

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Infections; Virus Diseases; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; DNA Virus Infections; Skin Diseases; Neoplasms, Squamous Cell; Skin Diseases, Infectious; Tumor Virus Infections; Skin Diseases, Viral; Papillomavirus Infections; Papilloma; Warts; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: C.ag-vs-B.HPV.V

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No