Immunotherapy in Eyelid Viral Papilloma

NCT ID: NCT06720467

Last Updated: 2025-08-17

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-11

Study Completion Date

2025-06-15

Brief Summary

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intralesional injection of Candida antigens for treating eyelid warts is supposed to have less destructive effect than other surgical interventions

Detailed Description

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Despite many surgical and interventional modalities of treating ocular warts, all have a destructive nature for this delicate tissue with a high recurrence rate. intralesional injection of Candida antigens was suggested to be an effective and safe treatment for such a condition aim: Providing safe and effective treatment of ocular wart. objective:

1. To determine the efficacy of intralesional injection of Candida antigens in the treatment of eyelids wart
2. To determine the safety of intralesional injection of Candida antigens in the treatment of eyelids wart
3. To report complications of intralesional injection of Candida antigens in the treatment of eyelids wart

Conditions

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Eye Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients with eyelid warts will receive treatment in the form of intralesional injection of Candida

Intralesional injection of 0.2 ml of 1/1000 solution of Candida albicans antigen using an insulin syringe directly into the warts; Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.). The same injection was repeated every 2 weeks until complete clearance for a maximum of six treatment sessions.

Group Type EXPERIMENTAL

Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.)

Intervention Type BIOLOGICAL

Intralesional injection of 0.2 ml of 1/1000 solution of Candida albicans antigen using an insulin syringe directly into the warts; Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.). The same injection was repeated every 2 weeks until complete clearance for a maximum of six treatment sessions.

Interventions

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Intralesional injection of Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.)

Intralesional injection of 0.2 ml of 1/1000 solution of Candida albicans antigen using an insulin syringe directly into the warts; Candida albicans 1:20 w/v 10 ml vial (Allergy Laboratories, INC. Oklahoma City, USA.). The same injection was repeated every 2 weeks until complete clearance for a maximum of six treatment sessions.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* patients with cutaneous eyelid viral warts whether single or multiple, with no concurrent systemic or topical treatment for warts. Patients aged more than 12 years, with sensitivity test, showed induration less than or equal to five mm. and patients can understand and comply with the requirements of the trials.

Exclusion Criteria

* pregnancy, breastfeeding, patients with immunodeficiency; like diabetics. In addition, patients with a history of hypersensitivity to any used component in this trial, asthma, or allergic skin diseases. Moreover, patients on any treatment modality for warts at least 1 month before the start of the study.
Minimum Eligible Age

12 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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Marwa Ahmed Khairy Elsayed Essa

Principle investigator, lecturer of ophthalmology, Faculty of Medicine, Zagazig University, Zagazig, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman Marie, Professor

Role: PRINCIPAL_INVESTIGATOR

Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt

Ghada Boghdadi, Professor

Role: STUDY_CHAIR

Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt

Locations

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Zagazig University

Zagazig, Zagazig, Egypt

Site Status

Countries

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Egypt

References

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Marei A, Nofal A, Alakad R, Abdel-Hady A. Combined bivalent human papillomavirus vaccine and Candida antigen versus Candida antigen alone in the treatment of recalcitrant warts. J Cosmet Dermatol. 2020 Mar;19(3):758-762. doi: 10.1111/jocd.13077. Epub 2019 Jul 22.

Reference Type BACKGROUND
PMID: 31328869 (View on PubMed)

Aldahan AS, Mlacker S, Shah VV, Kamath P, Alsaidan M, Samarkandy S, Nouri K. Efficacy of intralesional immunotherapy for the treatment of warts: A review of the literature. Dermatol Ther. 2016 May;29(3):197-207. doi: 10.1111/dth.12352. Epub 2016 Mar 15.

Reference Type BACKGROUND
PMID: 26991521 (View on PubMed)

Shaker ESE, Doghim NN, Hassan AM, Musafa SS, Fawzy MM. Immunotherapy in cutaneous warts: comparative clinical Study between MMR vaccine, tuberculin, and BCG Vaccine. J Cosmet Dermatol. 2021 Aug;20(8):2657-2666. doi: 10.1111/jocd.13921. Epub 2021 Jan 6.

Reference Type BACKGROUND
PMID: 33410249 (View on PubMed)

Other Identifiers

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immunotherapy in eyelid warts

Identifier Type: -

Identifier Source: org_study_id

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