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临床试验/NCT05902624
NCT05902624尚未招募早期 1 期

Evaluation of the Efficacy of Cryotherapy Combined With Intralesional Hepatitis B Virus Vaccine Versus Either Therapy in the Treatment of Multiple Cutaneous Warts :a Comparative Study

Assiut University0 个研究点目标入组 60 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
尚未招募
入组人数
60
主要终点
Compare the efficacy and safety of the combined treatment versus either therapy in the treatment of multiple cutaneous warts.

研究概览

简要总结

  1. investigate the efficacy and safety of combined cryotherapy with intralesional HBV vaccine injection in the treatment of multiple common warts.
  2. compare the efficacy and safety of the combined treatment versus either therapy in the treatment of multiple cutaneous warts.

详细描述

Introduction:

Warts are common, benign and epithelial proliferations and growths affecting the skin and/or the mucosa (Sterling JC,et al.,2014) caused by human papilloma virus (HPV) which is a double stranded DNA virus with a worldwide distribution(Pérez-González et al., 2022).

There are approximately 218 types of HPV identified as causing infections in humans (Magalhães et al., 2021).

Infection occurs predominantly via direct contact, although skin lesions can be transmitted indirectly, via contaminated surfaces, Abrasions and microtraumas expose the basal layer keratinocytes and facilitate contagion (EgawaN,et al 2015 and Vlahovic T.C.et al,2016).

The clinical manifestations of HPV-related diseases vary depending upon the HPV type and the site of inoculation (Burlamaqui et al., 2017).Extragenital cutaneous warts can present as common warts, plane warts, plantar warts (Abeck D. et al, 2019).HPV infection is one of the most common sexually transmitted infections with the most common manifestation of HPV in the genital area is anogenital warts or condylomata acuminate (Gofur, 2022). Infections due to these viruses may result in a wide spectrum of clinical manifestations in the skin and mucosa(Cubie, 2013).

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 (Participant)

入排标准

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

入选标准

  • Any patients with multiple cutaneous warts of any site.
  • Patients age above 10 years old
  • No concurrent systemic or topical treatment of warts

排除标准

  • Pregnancy and lactation.
  • History of any bleeding, clotting disorder or using anticoagulants
  • Chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and cardiovascular disorders.
  • Concurrent use of systemic or topical treatments of warts.
  • Patients with history of neuropathy or peripheral ischemia.
  • Patients with signs of inflammation or infection.
  • Patients with history of a serious systemic or anaphylactic reaction or allergy to a prior dose of HBV vaccine or to any of its components.

研究组 & 干预措施

Group intralesional injection of HBV vaccine

Other

Group 1: will include 20 patients with multiple cutaneous warts. They will be treated by intralesional injection of HBV vaccine into the largest wart by an insulin syringe every 2-weeks until complete clearance or for a maximum of 5 sessions.

干预措施: Hepatitis B Virus Vaccine(HBV) (Drug)

Group cryotherapy

Other

Group 2: will include 20 patients with multiple cutaneous warts. They will be treated by cryotherapy every 2-weeks until complete clearance or for a maximum of 5 sessions.

干预措施: Hepatitis B Virus Vaccine(HBV) (Drug)

Group cryotherapy with intralesional injection of HBV vaccine

Other

Group 3: will include 20 patients with multiple cutaneous warts. They will be treated by cryotherapy with intralesional injection of HBV vaccine into the largest wart by an insulin syringe every 2-weeks until complete clearance or for a maximum of 5 sessions.

干预措施: Hepatitis B Virus Vaccine(HBV) (Drug)

结局指标

主要结局

Compare the efficacy and safety of the combined treatment versus either therapy in the treatment of multiple cutaneous warts.

时间窗: 10 weeks

number of cutaneous warts will be measured every visit

Investigate the efficacy and safety of combined cryotherapy with intralesional HBV vaccine injection in the treatment of multiple common warts.

时间窗: 10 weeks

size of cutaneous warts in millimeters will be measured every visit

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

Maria Awny Armia

Principal Investigator

Assiut University

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