跳至主要内容
临床试验/NCT00558688
NCT00558688已完成不适用

A Photodynamic Therapy for Treatment of Actinic Keratoses

Northwestern University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年8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
20
试验地点
2
主要终点
Visual assessment of lesions

研究概览

简要总结

The purpose of this study is to compare the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs absence of treatment for actinic keratoses.

详细描述

This study seeks to evaluate the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs. absence of treatment for actinic keratoses

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Age greater than or equal to 18 years
  • Have a t least 4 nonhypertrophic AK lesions on the body
  • The subjects are in good health
  • The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate to the investigator

排除标准

  • Subjects who are pregnant or lactating
  • Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis
  • Subjects with use of photosensitizing drugs within 1 week of study start
  • Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
  • Subjects with systemic steroid therapy within 4 weeks before study entry
  • Subjects who received previous treatment of target AKs
  • Subjects with systemic treatment with chemotherapeutic agents, masoprocol (Actinex), immunotherapy, or retinoids within 2 months of study entry
  • Subjects with prior history of hypersensitivity reactions to lidocaine
  • Subjects who are unable to understand the protocol or to give informed consent

结局指标

主要结局

Visual assessment of lesions

时间窗: 4 weeks

次要结局

  • Patient subjective assessment and Safety(4 weeks)

研究者

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

Murad Alam

Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery

Northwestern University

研究点 (2)

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