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临床试验/NCT06749665
NCT06749665尚未招募不适用

Efficacy and Safety of Intralesional Injections of Candida Antigen, Polidocanol Sclerotherapy and Combined Candida Antigen With Polidocanol in Treatment of Patients With Common Warts

Sohag University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年12月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
75
试验地点
1
主要终点
size of warts

研究概览

简要总结

This study aims to evaluate the efficacy and safety of intralesional injections of candida antigen, polidocanol sclerotherapy and combined candida antigen with polidocanol in treatment of patients with common warts.

详细描述

Warts are benign proliferations of skin and mucosa caused by the human papillomavirus . Currently, more than 100 types of human papillomavirus have been identified, which is a non-enveloped double-stranded, circular, supercoiled DNA virus enclosed in an icosahedral capsid and comprising 72capsomers Immunotherapy in wart treatment is a type of biological therapy that uses substances to stimulate the immune system to help the body fight infected cells. This includes topical agents as imiquimod, sineacatechins, and Intralesional immunotherapy which become more preferred treatment line for several types of warts, several injectable agents have been examined such as vitamin D3, interferon alpha 2B and skin test antigens such as the candida antigen and purified protein derivatives or systemic immunotherapy as zinc, cimetidine.

Intralesional candida antigen has been successfully used in the treatment of warts with the potential advantages of promising efficacy, low cost, high safety profile, simple easy injection, association with distant response, absence of scarring and pigmentary changes and less pain than destructive therapies, and low or absent recurrence rates Treatments targeting and obliterating blood vessels such as pulsed dye laser and photodynamic therapy have been used in the treatment of common warts. Based on these observations, and the previous reports of the successful use of polidocanol in the treatment of various skin conditions with vascular components, the intralesional polidocanol therapy could be helpful in the treatment of common warts through the thrombotic occlusion and obliteration of blood vessels within the wart.

The complete and partial cure rates after intralesional polidocanol 3% injection in plantar warts were 60% and 25%, respectively

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age group: >18years.
  • Confirmed diagnosis by clinical and dermoscopic examination of common wart will be made.

排除标准

  • Patients who receive any treatment for wart in the last month before the study.
  • Patients with history of renal or liver disease.
  • Patients with any evidence of bleeding diathesis, vaso-occulusive or thrombo-embolic disorders.
  • Pregnant and lactating females.
  • Patients who receive immunosuppressive therapy.
  • Patients' refusal.
  • Patients with history or evidenced hypersensitivity to any component used in this study.

研究组 & 干预措施

Polidacanol

Active Comparator

will receive intralesional injection of (polidacanol 3% (Aethoxysklerol 3%,60mg/ ml ampoule, kreussler pharma, Germany) During the study, the dosage of the drug and frequency of treatment will be uniform in all patients. The base of each wart will inject until the lesion blanch using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until the resolution of warts or for a maximum of 6 sessions.

干预措施: polidacanol 3% (Drug)

Candida

Active Comparator

will receive intralesional injection of candida antigen at a dose of 0.2 ml. Each treatment will inject into the largest wart using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until complete clearance of warts or for a maximum of 6 treatment sessions.

干预措施: candida antigen (Biological)

Polidacanol and candida

Active Comparator

will receive intralesional candida antigen injection in the largest wart and intralesional injection of (polidacanol 3%) in all warts using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until complete clearance of warts or for a maximum of 6 treatment sessions

干预措施: polidacanol 3% (Drug)

Polidacanol and candida

Active Comparator

will receive intralesional candida antigen injection in the largest wart and intralesional injection of (polidacanol 3%) in all warts using an insulin syringe (29 Gage × 0.5-in) every 2 weeks until complete clearance of warts or for a maximum of 6 treatment sessions

干预措施: candida antigen (Biological)

结局指标

主要结局

size of warts

时间窗: session every 2 weeks until complete clearance of warts or for a maximum of 6 treatment sessions and one month after last session

measured by ruler) with photographic comparison at base line and before each session and one month after last session in relation to baseline lesion to detect response to therapy

次要结局

未报告次要终点

研究者

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

Heba Shawky Osman

Resident at Dermatology, Venereology, and Andrology Department Sohag University Hospital

Sohag University

研究点 (1)

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