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RecruitingNCT05291845Updated Jun 12, 2025

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

A Phase 2 interventional study of Candida antigen vaccine and Bivalent HPV vaccine in Warts and Human Papilloma Virus, sponsored by Zagazig University. Recruiting at 1 site in Egypt. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.

Sponsored by Zagazig University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Apr 2022; still recruiting 4 years 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
9 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Warts
  • Human Papilloma Virus

Browse trials for

03

In context

Warts

171 studies on the registry are indexed under Warts; 35 are open to participants now.

This study's planned enrollment of 162 is above the median of 70 across 155 interventional studies indexed under Warts.

Browse Warts studies →

Lead sponsor

Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnant female. to Candida antigen or bivalent HPV vaccine
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
162 participants (estimated)

Study arms

  • 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

  • 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

  • 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 · Biological: Bivalent HPV vaccine

Interventions

  • BiologicalCandida 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

  • 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

06

What researchers measure

Primary outcomes

  1. complete response

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

    Time frame: upto 3 months

  2. 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)

    Time frame: upto 3 months

  3. 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)

    Time frame: upto 3 months

Secondary outcomes

  1. recurrence rate after recovery

    appearance of new lesions or recurrence of previous one

    Time frame: follow up for 6 months after recovery

07

Study locations

1 of 1 sites recruiting
  • Reham Essam
    Zagazig, Al Sharqia 2543, Egypt
    Recruiting
08

References and documents

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. PubMed 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. PubMed 34464624 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2022 (actual). Primary completion is estimated for Oct 2025, 42 months after the start.

Of 18 phase 2 interventional studies under Warts, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 23. This study's planned 42 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2022
First posted
Mar 23, 2022
StartActual
Apr 3, 2022
Primary completionEst.
Oct 3, 2025
CompletionEst.
Dec 6, 2025
Last update
Jun 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05291845
Lead sponsor
Zagazig University
Responsible party
Reham Essam (Lecturer of Dermatology, Zagazig University) — Principal investigator
First posted
Mar 23, 2022
Start date
Apr 3, 2022
Primary completion
Oct 3, 2025 (estimated)
Completion
Dec 6, 2025 (estimated)
Last update
Jun 12, 2025

Study contacts

Reham Essam, MD
Contact
rereessam22@gmail.com
+201097709477
Reham Essam, MD
Contact
rekfarid@medicine.zu.edu.eg
+201097709477
Reham Essam, MD
principal investigator · Zagazig University
Ahmad Nofal, MD
study director · Zagazig University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Human papillomavirus vaccine, L1 type 16, 18

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