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临床试验/NCT01444989
NCT01444989已完成不适用

Development and Validation of a Quality of Life Instrument for Actinic Keratosis

Wake Forest University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年9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
150
试验地点
2
主要终点
Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosis

研究概览

简要总结

Actinic keratoses (AKs) are some of the most common lesions seen by dermatologists. Flesh colored to erythematous, these lesions often present with scaling or crusting in sun damaged regions of the body. While they are physically visible and often palpable, these changes can also result in psychosocial changes in patients, including embarrassment about their skin or reduction in leisure activities to avoid further sun exposure. At the same time, AKs are known to progress in a significant number of cases to squamous cell carcinoma (SCC), a concern in terms of its metastatic potential.

The primary purpose of developing this questionnaire is to examine how well it can potentially identify patients with actinic keratoses. However, since AK is associated with significant detriment to quality of life for validity/reliability assessment, the investigators propose to give a compilation of four self-assessment questionnaires (not specific to AK but validated for skin health in general) to subjects with at least one actinic keratosis and age- and sex- matched participants without AKs, defined as the control population. These will include the SKINDEX-16, the DLQI and the Skin Health Calculator, as well as a questionnaire composed of items specific to predisposition to AKs to be able to better assess the discriminatory power of the questionnaire.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

  • Male or female, age 18 years or older being seen in a dermatology clinic
  • Informed consent of participation must be given by subject

排除标准

  • Inability to complete all study questionnaires.
  • Subjects who are unable to read and write English

结局指标

主要结局

Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosis

时间窗: Baseline

We are developing an actinic keratosis risk assessment questionnaire and is designed to distinguish patients who have a higher likelihood of having a diagnosis of actinic keratosis. The outcome measure is the difference in scores between those with actinic keratosis and those without.

次要结局

  • The correlation between the AKRQ and Skin Health Calculator scores.(Baseline)
  • Correlation between AKRQ and DLQI scores(Baseline)
  • The correlation between AKRQ and Skindex-16 scores(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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