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临床试验/NCT04936932
NCT04936932已完成不适用

Laser Treatment of Basal Cell Carcinoma

Sciton2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Sciton
入组人数
3
试验地点
2
主要终点
Complete clearance of BCC

研究概览

简要总结

Laser treatment of Basal cell carcinoma

详细描述

The purpose of this pilot study is to examine the treatment of superficial basal cell carcinoma (BCC) with laser technology. The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC.

研究设计

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

入排标准

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

入选标准

  • Healthy subjects 18 years of age or older
  • Lesion is biopsy-proven superficial BCC <= 2.0 cm in largest diameter
  • BCC is on trunk or extremities
  • Seeks and is scheduled for treatment of BCC
  • Willing to have photographs taken of the treatment area
  • Ability to understand and the willingness to sign a written informed consent document
  • Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions

排除标准

  • Subjects with a BCC lesion that requires excision. This would include relatively larger lesions (>2.0 cm in diameter), high risk lesions as defined by American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases.
  • Subjects unable to follow-up for the full 12-months
  • Subjects not willing to have biopsy taken from the treatment area
  • Subjects with herpes simplex virus infection, impetigo or other disqualifying condition as determined by a dermatologist on the treatment area or effecting healing or outcome

结局指标

主要结局

Complete clearance of BCC

时间窗: 1 year

Histological confirmation of BCC clearance. Biopsy will be taken from the treatment site to confirm complete BCC clearance

次要结局

  • Cosmetic outcome(1 year)

研究者

发起方
Sciton
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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