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临床试验/NCT04288817
NCT04288817Unknown3 期

Efficacy of Cryotherapy Combined With Intralesional Tuberculin Purified Protein Derivative (PPD) Versus Interlesional Tuberculin PPD Monotherapy in the Treatment of Multiple Common Warts

Assiut University0 个研究点目标入组 40 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
3 期
入组人数
40
主要终点
Number of lesions

研究概览

简要总结

The investigate the efficacy and safety of combined 'cryo-immuno-therapy' versus intralesional tuberculin purified protein derivative (PPD) antigen immunotherapy alone for multiple common warts

详细描述

Common warts are benign skin lesions caused by the human papillomavirus (HPV). The dorsal surface of the hands and fingers are the main predilection sites. Cryotherapy is frequently used to eradicate common warts via necrotic destruction of HPV-infected keratinocytes or by inducing of an effective cell-mediated immune response. However, the cure rates of cryotherapy are only around (44-47%) .

Intralesional antigen immunotherapy represents a promising therapeutic approach for the treatment of different types of warts, particularly if multiple and/or recalcitrant.

The investigate the efficacy and safety of combined 'cryo-immuno-therapy' versus intralesional tuberculin purified protein n immunotherapy alone for multiple common warts.

Although intralesional immunotherapy - compared to conventional therapeutic methods - has been generally along with better outcome, lower incidence of side effects and less recurrence, it is not still approved as a standard method of treatment in patients with wart , because the majority of available studies are open-labeled and randomized, placebo-controlled trials are very scarce.

The immune system plays an important role in the spontaneous resolution of warts. The immune mechanisms against HPV include the development of cell-mediated immune response with activation of T helper1 (Th1) lymphocytes resulting in long-term immunity . Stimulation of the immune system would clear warts in other locations, eliminating the need for the local treatment for each individual wart .

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • A dults older than 18 years
  • multiple (>3 warts) common warts .
  • not currently using other treatments for a wart .
  • not had relapsed at least once after treatment with any of the tissue-destructive modalities.
  • Positive tuberculin skin test.

排除标准

  • Acute febrile illness, history of asthma, allergic skin disorders.-1 2- Pregnancy or lactation. 3- Cold-induced diseases. 4- Immunosuppression.

结局指标

主要结局

Number of lesions

时间窗: 4 months

The following grading system will be used to evaluate treatment response: \*Complete response: responders who show 100% improvement (disappearance of all warts and return to normal skin markings). Marked response: responders who show 76 to 99% decrease in number and/or decrease in apparent size, as assessed by a clinician and photographic evaluation also known as near-complete response. * Moderate response: partial responders show 25 to 75% improvement. * No or minimal response: less than 25% decrease in size/numbers of all warts. the study

Size of lesions

时间窗: Two months

By decreasing in size after treatment and compare the response of the lesions tow treatment lines

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

Hiba A H alshaaby

Principal investigator

Assiut University

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