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临床试验/NCT06720467
NCT06720467已完成2 期

Role of Immunotherapy in the Treatment of Eyelid Viral Papilloma

Zagazig University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年6月11日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
22
试验地点
2
主要终点
complete response

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

complete response

时间窗: 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

次要结局

  • partial response(after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions)
  • Failure(after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions)
  • complications(after maximum 6 treatment sessions of intralesional injection with 2 weeks between the successive sessions)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Marwa Ahmed Khairy Elsayed Essa

Principle investigator, lecturer of ophthalmology, Faculty of Medicine, Zagazig University, Zagazig, Egypt

Zagazig University

研究点 (2)

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Immunotherapy in Eyelid Viral Papilloma | 临床试验