Immunotherapy in Eyelid Viral Papilloma

August 14, 2025 updated by: Marwa Ahmed Khairy Elsayed Essa, Zagazig University

Role of Immunotherapy in the Treatment of Eyelid Viral Papilloma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt, 44519
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete response
Time Frame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
to report the complete response defined by the efficacy of intralesional injection of Candida antigen in achieving complete disappearance of eyelid warts and return to normal skin
after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
partial response
Time Frame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
to report Partial response which will be considered when wart regress in size by 50%-99%.
after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
Failure
Time Frame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
to report failure which will be considered if less than 50% decrease in wart size.
after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
complications
Time Frame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
to report any complications in the form of hypersensitivity reaction, erythema, or induration
after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Ayman Marie, Professor, Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt
  • Study Chair: Ghada Boghdadi, Professor, Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2024

Primary Completion (Actual)

March 15, 2025

Study Completion (Actual)

June 15, 2025

Study Registration Dates

First Submitted

December 1, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • immunotherapy in eyelid warts

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eye Infections

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe