Immunotherapy in Eyelid Viral Papilloma

Phase 2

Active, not recruiting

• Conditions: Eye Infections

• Registration Number: NCT06720467
• Lead Sponsor: Zagazig University

Brief Summary

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

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 Timeline

• Study Start: 2024-06-11
• Status Verified: 2024-12
• Study First Submitted: 2024-12-01
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-06
• Primary Completion: 2025-03-15
• Last Update Submitted: 2025-04-11
• Study Completion: 2025-04-15
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
complete response	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 Outcome Measures

Name	Time	Method
partial response	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%.
Failure	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.
complications	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

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Egypt