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

NCT05291845 | Recruiting Phase 2

• 1 other identifier: C.ag-vs-B.HPV.V
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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

Conditions

Warts; Human Papilloma Virus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• recurrence rate after recovery

  follow up for 6 months after recovery

Study Arms (3)

Candida antigen group

EXPERIMENTAL

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

Bivalent HPV vaccine

EXPERIMENTAL

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

both agents group

EXPERIMENTAL

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; Biological: Bivalent HPV vaccine

Interventions

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

Candida antigen group; both agents 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

Bivalent HPV vaccine; both agents group

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant female. Hypersensitivity to Candida antigen or bivalent HPV vaccine

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Reham Essam

Zagazig, Al Sharqia, 2543, Egypt

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Related 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

MeSH Terms

Conditions

Warts

Interventions

human papillomavirus vaccine, L1 type 16, 18

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Reham Essam, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

• Ahmad Nofal, MD

  Zagazig University

  STUDY DIRECTOR

Central Study Contacts

Reham Essam, MD

CONTACT

+201097709477; rereessam22@gmail.com

Reham Essam, MD

CONTACT

+201097709477; rekfarid@medicine.zu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 23, 2022
• Study Start: April 3, 2022
• Primary Completion: October 3, 2025
• Study Completion: December 6, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)