NCT03082560Unknown不适用
Design and Validation of a New Assessment Tool for Lichen Planopilaris, the Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)
研究概览
简要总结
The study's Primary Objective is to design and validate a grading system for objective and accurate assessment of lichen planopilaris.
Secondary Objectives:
- To assess change in symptoms such as pain and itch using a Numeric Rating Scale(NRS) scores and quality of life using the Dermatology Life Quality Index (DLQI) scores
- To correlate this grading system with patient skin biopsies evaluating disease activity on a microscopic level
- To correlate this grading system with digital global photography and trichoscopy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects in general good health between the ages of 18 and 80 years old
- •Clinical and histologic diagnosis of lichen planopilaris
- •Subject is able to understand and sign informed consent
- •Subject is able to complete the study and comply with study procedures
- •Subject has no known allergy to non-toxic ink
- •Subjects should be managed by an Massachusetts General Hospital dermatologist for their lichen planopilaris for the duration of the study
排除标准
- •Eligible subjects will be excluded from participation if they meet any of the following criteria:
- •Presence of dermatoses that might interfere with LPP diagnosis and/or evaluation such as seborrheic dermatitis or psoriasis
- •Other selected concomitant causes of hair loss, including discoid lupus erythematosus, central centrifugal cicatricial alopecia (CCCA), telogen effluvium
- •Abnormal TSH laboratory value >1 standard deviation above normal within last year
- •Any significant medical condition that may prevent the patient from participating in the study according to the investigator's assessment
- •Any known allergy to non-toxic ink Related to Biopsy
- •History of poor wound healing or blood-clotting abnormality
- •History of keloid formation or hypertrophic scarring
- •Regular intake of high doses of aspirin or anti-coagulant medications
- •Hypersensitivity to local anesthetics
- •History of poorly controlled diabetes mellitus
- •Pregnant, nursing or planning a pregnancy
结局指标
主要结局
Boston Grade of Activity in Lichen Planopilaris (Boston GOAL)
时间窗: 6 months
Design and validate a grading system for objective and accurate assessment of lichen planopilaris.
次要结局
未报告次要终点
研究者
Maryanne Makredes Senna
Dermatologist
Massachusetts General Hospital
研究点 (1)
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