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Immunotherapy in Eyelid Viral Papilloma

Role of Immunotherapy in the Treatment of Eyelid Viral Papilloma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06720467
Enrollment
22
Registered
2024-12-06
Start date
2024-06-11
Completion date
2025-06-15
Last updated
2025-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Infections

Keywords

eyelid warts, candida antigen, eyelid papilloma

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

Interventions

BIOLOGICALIntralesional 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.

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
complete responseafter maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessionsto 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

MeasureTime frameDescription
partial responseafter maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessionsto report Partial response which will be considered when wart regress in size by 50%-99%.
Failureafter maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessionsto report failure which will be considered if less than 50% decrease in wart size.
complicationsafter maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessionsto report any complications in the form of hypersensitivity reaction, erythema, or induration

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026