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临床试验/NCT06150144
NCT06150144招募中3 期

The Efficacy and Safety of Using Intralesional 5-fluorouracil for Basal Cell Carcinoma: Clinical Trail

University of Aleppo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
40
试验地点
1
主要终点
Histologic complete response rate

研究概览

简要总结

The investigators want to assess the safety and efficacy of using intralesional 5-FU for the management of different types of BCC (including all the types EXCEPT the infiltrative one), by estimating different outcomes after the intralesional administration of 5-FU to BCC patient. Patients are randomly selected from the outpatient dermatologic clinic in the Aleppo University Hospital (AUH) over a period of 12 months and then these patients are followed up over another 12 months.

详细描述

Brief Description: The investigatorswant to assess the safety and efficacy of using intralesional 5-FU for the management of different types of BCC (including all the types EXCEPT the infiltrative one), by estimating different outcomes after the intralesional administration of 5-FU to BCC patient. Patients are randomly selected from the outpatient dermatologic clinic in the Aleppo University Hospital (AUH) over a period of 12 months and then these patients are followed up over another 12 months.

Detailed Description: Clinicians routinely consider surgical removal as the best and sometimes the only cost-effective treatment of Basal cell carcinoma, but several studies have discussed other promising treatment approaches for BCC including 5% 5-FU cream which is indicated for the treatment of superficial BCC, in addition many studies have investigated the efficacy of the combination of 5-FU with Imiquimode or cryoablation presenting promising results, however when searching the medical literature there was only few studies dealing with types other than superficial BCC, in addition intralesional administration of 5-FU alone was not thoroughly assessed so far even though there are some studies showing positive results suggesting 5-FU to be a cost-effective alternative to surgical excision, but as these papers are asking for further studies and stronger evidence the invistigators decided to conduct this study in accordance with the best recommendations reached by latest medical literature.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 5 Years to 90 Years (Child, Adult, Older Adult).
  • Volunteer to participate in study
  • Superficial lesion
  • Nodular lesion (x ≤ 1.5 cm) patients are seen at the outpatient Department or in the dermatology wards at Aleppo University Hospital (AUH) over 12 months' period.

排除标准

  • Ulcerative.
  • Nodular lesion (x ≥ 1.5 cm)

研究组 & 干预措施

Patients with intralesional 5-fluorouracil.

Experimental

干预措施: 5-Fluorouracil (Drug)

Patients with Surgery

Active Comparator

干预措施: SURGERY (Other)

结局指标

主要结局

Histologic complete response rate

时间窗: 1 - 2 months

defined by absence of any tumor on the basis of histologic analysis of the excised specimen.

次要结局

  • Sides effect(1 year)

研究者

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

Ibrahim Arnaout

Principal Investigator

University of Aleppo

研究点 (1)

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