Dermatomyositis Skin Disease Severity Measure Validation

皮肌炎皮肤病严重程度测量验证

• 批准号: 6533464
• 负责人: JOSPEH L JORIZZO
• 金额: $ 7.2万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-05 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6533464
• 关键词: FK506; biopsy; chloroquine; chronic disease /disorder; clinical research; dermatomyositis; drug screening /evaluation; histology; human subject; inflammation; measurement; patient oriented research; pigmentation; pruritis; psoriasis; quality of life; skin disorder chemotherapy; skin pharmacology; skin ulcer; topical drug application

DESCRIPTION (provided by applicant): Dermatomyositis is an inflammatory myopathy of unknown cause accompanied by a characteristic cutaneous eruption. Despite the frequently debilitating severity of the skin involvement, most studies have focused on the muscle disease and no controlled studies have been done to study systematically the skin disease in dermatomyositis or its treatment. This is in part due to the lack of standard methods for evaluating the skin involvement of dermatomyositis. Validated measures that can be used to judge the severity of skin involvement of patients with dermatomyositis and to evaluate and compare different therapies are not available yet. The purpose of this study is to validate a dermatomyositis skin disease severity measure (DSSI) developed based on the Psoriasis Area and Severity Index (PASI), to determine the clinical significance of changes in the DSSI, and to collect data on the expected effect size and variability of two common treatments. The hypothesis is that a modified version of the psoriasis severity measure can be used to accurately measure the severity of skin disease in patients with dermatomyositis. The successful completion of the study will permit future studies that assess the effectiveness of different treatments for dermatomyositis skin disease and provide data that could be used for power analysis calculations for designing future full-scale studies.

描述（由申请人提供）：皮肌炎是一种原因不明的炎性肌病，伴有特征性皮疹。尽管皮肤受累的严重程度经常使人衰弱，但大多数研究都集中在肌肉疾病上，没有进行对照研究来系统地研究皮肌炎中的皮肤疾病或其治疗。这部分是由于缺乏标准的方法来评估皮肌炎的皮肤受累。可用于判断皮肌炎患者皮肤受累的严重程度以及评估和比较不同治疗方法的有效措施尚不可用。 本研究的目的是验证皮肌炎皮肤病严重程度测量（DSSI）的基础上开发的PSSI面积和严重程度指数（PASI），以确定在DSSI的变化的临床意义，并收集数据的预期效果大小和变异性的两种常见的治疗。假设是银屑病严重程度测量的修改版本可用于准确测量皮肌炎患者皮肤疾病的严重程度。 该研究的成功完成将允许未来的研究评估皮肌炎皮肤病的不同治疗方法的有效性，并提供可用于设计未来全面研究的功效分析计算的数据。