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临床试验/NCT00843323
NCT00843323已完成不适用

Histological and Immunohistochemical Study of Photodamaged Skin Submitted to MAL-PDT

University of Sao Paulo0 个研究点目标入组 26 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26

研究概览

简要总结

In this study, 26 patients were selected and included for full-face photodynamic therapy sessions. All patients presented signs of photoaging skin and multiple actinic keratosis. Photographs and Biopsies were taken before and after the procedure. Clinical and histological aspects as well as immunohistochemical aspects regarding neocollagen induction and tumor expression were evaluated.

详细描述

Study design:

Patients and methods:

26 patients (16 females, 8 males) age 35-90 years, mean 59,4 y Skin types I-IV, severely photodamaged facial skin Multiples Aks on the face ( total 268) minimum of 3 per patient Approved by local ethical committee and informed consent given

Treatment procedure:

Prior curettage Full-face MAL application ( Metvix ®, Galderma France) 1,5 tube per treatment Incubation time 3 hs - in the first treatment session; and 1,5 h - in the 2 nd and 3 rd sessions Illumination LED (Aktilite® Photocure, Norway) 635 nm 37 J/cm2 3 treatments performed, one month apart Pain monitoring: forced air cooling device

研究设计

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

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with severe photodamage and at least 3 actinic keratosis on the face

排除标准

  • Pregnancy, laser, chemical peel, imiquimod or 5-Fu treatment in the last year

研究者

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

Luis Antonio Torezan

ASSOCIATE PROFESSOR OF DERMATOLOGY

University of Sao Paulo

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