Clinical trial NCT06720467: Immunotherapy in Eyelid Viral Papilloma
Official title: Role of Immunotherapy in the Treatment of Eyelid Viral Papilloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Eye Infections
Keywords: eyelid warts, candida antigen, eyelid papilloma
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-12-06
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: complete response
timeFrame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
Secondary outcomes:
measure: partial response
timeFrame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
measure: Failure
timeFrame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
measure: complications
timeFrame: after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt
name: Ayman Marie, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, Egypt
name: Ghada Boghdadi, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.