跳至主要内容
临床试验/NCT05652998
NCT05652998进行中(未招募)4 期

Comparative Study Between Intralesional Injection of Autologous Plasma Rich Platelets Versus Candida Antigen in Patients With Plane Warts

South Valley University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年10月15日最近更新:
适应症

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Treatment of plane wart

研究概览

简要总结

To compare the efficacy of intralesional injection of autologous plasma rich platelets and candida antigen in treatment of patients with plane warts .

详细描述

Cutaneous warts are benign tumors caused by infection of keratinocytes by different serotypes of human papillomavirus(HPV). Its incidence increases during the school years to reach a peak in adolescence and early adulthood, then declines rapidly through the twenties and more gradually thereafter.

Plane warts are mainly caused by HPV serotypes 3, 10, 28, and 41, presenting mainly in children and young adults. They present as skin colored or may be hyperpigmented smooth-surfaced, slightly elevated or flat-topped papules. They are polygonal or round in shape and range in sizes from 1 to 5 mm. The main sites of predilection for the plane warts are the face, dorsal aspects of the hands and forearms, often in a linear array.

Platelet rich plasma (PRP) is an autologous blood-derived product enriched in platelets. Platelets, also called thrombocytes, are blood cells that cause blood clots and other necessary growth healing functions. PRP represents a new bio technology that is part of the growing interest in tissue engineering and cellular therapy today. While it is of autologous origin, it reduces the possibility of adverse effects and transfusion-transmitted infections, so it is well-tolerated therapy for the patients. PRP has been used in the treatment of many cutaneous diseases such as alopecia and acne vulgaris. Its utility has been extended to other cutaneous diseases as melasma, hyperpigmentation, and burns, wherever it elicits tissue repair and regeneration.

Intralesional immunotherapy depends on the ability of the immune system to recognize certain viral, bacterial, and fungal antigens, such as Candida or Trichophyton antigens that induce a delayed-type hypersensitivity reaction, not only to the antigen but also against the wart virus, which in turn increases the ability of the immune system to recognize and eradicate HPV. This stimulated immune response could then subsequently destroy all the injected and noninjected lesions on the body, rather than the locally treated lesion.

Intralesional antigen immunotherapy has recently received increased attention and is considered by many authors a promising modality for the treatment of different types of warts, including the recurrent and recalcitrant variants.

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
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients proved as having clinically evident plane warts.
  • Patients with both sexes with no age limits.

排除标准

  • Patient receiving immune suppressive drugs.
  • Patients with major comorbidities or concomitant malignancies.
  • Patients with any evidence of immunosuppression including HIV infection.
  • Patients with any eczematous skin disorder
  • Those with any history of hypersensitivity to Candida albicans antigen.
  • Patients with chronic systemic medical diseases and bleeding disorders .

结局指标

主要结局

Treatment of plane wart

时间窗: 6 months

Evaluation of the efficacy of intradermal injection of candida albicans antigen versus autologous platelet rich plasma in treatment of plane warts

次要结局

  • Treatment of plane wart(6 Months)

研究者

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

Randa Abd Al-naser Hussien Kamel

principal investigator

South Valley University

研究点 (1)

Loading locations...

相似试验