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临床试验/NCT02880904
NCT02880904终止不适用

Development of a Vulvar Scarring Grading Scale for Lichen Sclerosus

Northwestern University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
1
主要终点
Scarring severity grading scale for vulvar lichen sclerosus

研究概览

简要总结

The study aims to validate a vulvar scarring grading scale for lichen sclerosus (LS).

详细描述

Utilizing the vulvar disorders registry, protocol #STU00001056, the research team seeks to analyze the medical record data, including standard of care vulvar photographs, of the vulvar LS population at Northwestern Memorial Hospital (NMH) and the outpatient clinics of Northwestern Medicine (NM). These photographs will be used to develop a vulvar scarring grading scale for LS. The objective measurement of scarring severity in LS deidentified standard-of-care patient photographs will be correlated with clinical examination findings to assess validity of the grading scale. The development of an objective and standardized grading scale will assist with the longitudinal evaluation of individual disease, assessment of impact of therapy on scarring, and inform treatment modifications. Further, objective grading of scarring would also provide the opportunity to search for potential correlation between QoL scores and severity of clinical states in scarring dermatoses.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

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

入选标准

  • Patients seen at Northwestern Medicine Department of Dermatology and/or Department of Obstetrics and Gynecology, who were seen by Dr. Bethanee Schlosser, and/or other members of the Vulvar Mucosal Specialty Clinic team in any of their respective clinic settings and underwent complete mucocutaneous examination.
  • Patients with histologically confirmed vulvar LS.

排除标准

  • Patients who refuse complete mucocutaneous examination.
  • Patients who refuse recommended diagnostic procedures.
  • Pregnant women or prisoners.

结局指标

主要结局

Scarring severity grading scale for vulvar lichen sclerosus

时间窗: one year

次要结局

  • Correlation of severity of vulvar LS scarring, as documented at time of clinical examination and compared to scores on the LS grading scale, with the patient quality of life at the time of examination.(one year)

研究者

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

Stephanie Rangel

Research Assistant Professor of Dermatology

Northwestern University

研究点 (1)

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