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Completed

NCT Number: NCT06720467

Immunotherapy in Eyelid Viral Papilloma

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

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Key information

Conditions

Eye Infections Eye Diseases Infections

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zagazig University

Zagazig, 44519, Egypt

About this study

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:

  • To determine the efficacy of intralesional injection of Candida antigens in the treatment of eyelids wart
  • To determine the safety of intralesional injection of Candida antigens in the treatment of eyelids wart
  • To report complications of intralesional injection of Candida antigens in the treatment of eyelids wart

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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%.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Role of Immunotherapy in the Treatment of Eyelid Viral Papilloma

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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