Immunotherapy in Eyelid Viral Papilloma

Phase 2CompletedNCT06720467

Zagazig University22 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eye Infections

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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zagazig University

Zagazig, Zagazig, Egypt

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

partial response

to report Partial response which will be considered when wart regress in size by 50%-99%.

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

Failure

to report failure which will be considered if less than 50% decrease in wart size.

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

complications

to report any complications in the form of hypersensitivity reaction, erythema, or induration

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

Data from ClinicalTrials.gov

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