Immunotherapy in Eyelid Viral Papilloma

NCT06720467 | Completed Phase 2 FDA Drug

• 1 other identifier: immunotherapy in eyelid warts
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eye Infections

Keywords

eyelid warts, candida antigen, eyelid papilloma

Outcome Measures

Primary Outcomes (1)

• complete response

  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 Outcomes (3)

• partial response

  after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions

• Failure

  after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions

• complications

  after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions

Study Arms (1)

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

EXPERIMENTAL

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.)

Interventions

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

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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Zagazig, 44519, Egypt

Location

Related Publications (3)

• 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.

  PMID: 31328869 BACKGROUND

• 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.

  PMID: 26991521 BACKGROUND

• 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.

  PMID: 33410249 BACKGROUND

MeSH Terms

Conditions

Eye Infections

Condition Hierarchy (Ancestors)

Infections; Eye Diseases

Study Officials

• Ayman Marie, Professor

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

  PRINCIPAL INVESTIGATOR

• Ghada Boghdadi, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, lecturer of ophthalmology, Faculty of Medicine, Zagazig University, Zagazig, Egypt

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 6, 2024
• Study Start: June 11, 2024
• Primary Completion: March 15, 2025
• Study Completion: June 15, 2025
• Last Updated: August 17, 2025

Record last verified: 2024-12

Locations

EG (1)