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临床试验/NCT03158168
NCT03158168Unknown3 期

Intralesional Candidal Antigen Versus Intralesional Zinc Sulphate in Treatment of Cutaneous Warts, A Randomized Clinical Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
70
试验地点
1
主要终点
complete resolution of the injected wart

研究概览

简要总结

Warts are common and infectious viral diseases of the skin and are prevalent worldwide. Warts are caused by the human papilloma virus (HPV), which has more than 100 strains; some of them are known to be premalignant .Although warts can appear at any age, they are more common in children and adolescents. The prognosis of warts cannot be predicted. In some patients they may spontaneously disappear, whereas others show persistence and progression with spreading to other body sites, leading to physical and emotional distress to the patients. [ 1 ].

详细描述

Forty percent of children spontaneously clear in two years without treatment owing to natural immunity [ 2,3.]. However, warts can persist and increase in size and number [2] .

Warts may reflect a localized or systemic cell-mediated immune (CMI) deficiency to HPV. Various reasons like lack of production of memory T cells to target HPV infection, failure of clonal expansion of lymphocytes to adequate stimulation, inability of T lymphocytes to traffic to sites of infection and weak effector response mechanism have been hypothesized. [4] .] Consequently, warts are particularly exuberant in patients with Hodgkin's disease, AIDS and those on immunosuppressant [ 5 ].

The conventional modalities in treatment of warts include destructive therapies such as salicylic acid, trichloroacetic acid, cryotherapy, silver nitrate, phenol, canthiridin, electrocautary, surgical interventions and lasers; antiproliferative agents such as bleomycin, vitamin D analogs, podophyllin, and 5-fluro uracil; antiviral agents such as cidofovir and retinoids. Because of the cumbersome nature of these procedures and a high risk of recurrence, immunotherapy is becoming more and more popular, especially in the treatment of refractory cutaneous and genital warts [ 6 ] . It enhances recognition of the virus by the immune system. This allows not only clearing of the treated wart, and frequently warts at distant anatomic sites, but also may prevent future clinical infection [ 7 ] .

Immunotherapy in warts can be administered by various methods. The first method is topical application of certain inorganic molecules that are capable of eliciting a contact hypersensitivity reaction with secondary activation of an immunological response [ 8 ] . A second modality is the use of oral immune modulators such as cimetidine and zinc(10mg/kg/day for 2months) [ 9 , 10 ] .

A third method is Intralesional injection of immunotherapeutic agent that utilizes the ability of the immune system to mount a delayed type hypersensitivity response to various antigens and also the wart tissue leading to production of Th1 cytokines which activate cytotoxic and natural killer cells to eradicate HPV infection. This clears not only the local warts but also distant warts unlike traditional wart therapies [ 11 ] .

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
5 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients with ages ranging from 10 to 40 years with cutaneous common or planter wart ,
  • or were either resistant to treatment
  • or had relapsed at least once after treatment with any of the tissue-destructive modalities

排除标准

  • .- Patients with any evidence of immunosuppressant,
  • eczematous skin disorder,
  • those with any history of hypersensitivity to Candida albicans antigen,
  • pregnant or lactating women,
  • and those who received any wart treatment 1 month before the start of the study will be excluded from the study

研究组 & 干预措施

study group

Experimental

The first group will receive Intralesional injection of Candidal antigen with a dose of (0.1ml -0.3ml) by insulin syringe in the largest wart at the first visit.( Only those patients who showed a positive response to the Candida test antigen).I njections will be repeated for all patients into the same lesion every 3 weeks for three treatment sessions. Follow up for next six months for any recurrences.

Storage: A 1ml multidose vial of candidal antigen (Candin) which is an intradermal test antigen, stored between 2c-8c.

干预措施: Candida Antigen (Drug)

control group

Active Comparator

The second group will receive an IL injection of 2%Zn sulfate with a dose of (0.1ml-0.3ml) by insulin syringe ,in the largest one .the wart is injected with the solution till blanching or bleb formation. Subcutaneous injections and acral parts such as fingers and toes will be avoided, as it may cause vascular necrosis [19]. Injections will be repeated for all patients into the same lesion every 2 weeks for three treatment sessions.Follow up for next six months for any recurrences.

Preparation of 2% zinc sulfate: A measure of 2g. of zinc sulfate powder is to be dissolved in 100 ml of sterile distilled water and autoclaved at 95c for 20 min(20).

干预措施: Zinc Sulfate (Drug)

结局指标

主要结局

complete resolution of the injected wart

时间窗: 9 weeks

by photography

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

MAAbdelsalam

principle investigator

Assiut University

研究点 (1)

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