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

NCT ID: NCT05291845

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-03

Study Completion Date

2025-12-06

Brief Summary

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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

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* 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

Conditions

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Warts Human Papilloma Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Candida antigen vaccine

Intervention Type 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

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.

Group Type EXPERIMENTAL

Bivalent HPV vaccine

Intervention Type 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

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.

Group Type EXPERIMENTAL

Candida antigen vaccine

Intervention Type 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

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Reham Essam

Lecturer of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reham Essam, MD

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Ahmad Nofal, MD

Role: STUDY_DIRECTOR

Zagazig University

Locations

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Reham Essam

Zagazig, Al Sharqia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Reham Essam, MD

Role: CONTACT

+201097709477

Reham Essam, MD

Role: CONTACT

+201097709477

Facility Contacts

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Reham Essam

Role: primary

01097709477

References

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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.

Reference Type BACKGROUND
PMID: 31369771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34464624 (View on PubMed)

Related Links

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https://doi.org/10.1016/j.jaad.2019.07.070

Intralesional versus intramuscular bivalent human papillomavirus vaccine in the treatment of recalcitrant common warts

https://doi.org/10.1016/j.jaad.2021.08.040

Comparative efficacy of intralesional Candida antigen, intralesional bivalent human papilloma virus vaccine, and cryotherapy in the treatment of common warts

Other Identifiers

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C.ag-vs-B.HPV.V

Identifier Type: -

Identifier Source: org_study_id

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