Spatial Frequency Domain Imaging, Comparison of a Novel Method to Quantify Skin Fibrosis With Currently Used Methods in Scleroderma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Baseline SFDI measurements of skin thickness
研究概览
简要总结
Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased mortality. Currently imprecise and subjective methods that varies amongst different doctors for the same patient are available to quantify skin fibrosis in patients, by "pinching" their skin and assessing how thick it is; this is the method used to determine the modified Rodnan skin score (mRSS).
Skin thickness and the amount of fibrosis can change over time due to disease progression or in response to therapy. In this research, longitudinal measurements will be taken to determine if spatial frequency domain imaging (SFDI) can detect changes in skin thickness that occur over time in response to therapy or from disease progression in scleroderma patients.
This study will compare SFDI with other clinical outcome assessments of skin thickness and fibrosis in scleroderma patients including mRSS, skin biopsy histology, scleroderma skin patient reported outcome (SSPRO), ultrasound, and durometry (durometer measures skin hardness). SFDI information will also be compared with capillaroscopy (allows for non-invasive imaging of the nailfold capillaries) if available from the electronic medical record. If SFDI correlates well with other clinical outcome assessments, it may be used in the future as a rapid, non-invasive tool for monitoring disease activity in scleroderma patients.
详细描述
The overall objective of this study is to determine if a light emitting diode (LED) -based SFDI instrument can be used to detect changes in skin thickness over time in SSc patients.
Number of subjects:
60 patients with scleroderma and 32 control subjects without scleroderma
Study procedures:
All subjects will have 6 areas of the body, right and left fingers, hands, and forearms, measured with an LED-based SFDI instrument every 3 months for the first 12 months and then every 6 months through 36 months. The right and left upper arms of subjects may be measured with the SFDI instrument if subjects are able to comfortably extend their arms.
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
- 是
入选标准
- •Participants must meet at least one of the following:
- •Have SSc as defined by the American College of Rheumatology (SSc subjects only)
- •Suspected of having SSc based on clinical symptoms as determined by their physician (SSc subjects only)
- •Defined as a healthy control (does not have SSc or another known disease that in the opinion of the investigator could confound the results)
排除标准
- •Diagnosis of skin malignancy within the previous 2 years, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ.
- •Presence of wounds or skin rashes at the site of Spatial frequency domain imaging (SFDI) measurement or skin biopsy
- •Presence of other co-morbid illnesses with an estimated median life expectancy < 5 years.
研究组 & 干预措施
Scleroderma Participants
Participants in this arm will be asked to complete the Fitzpatrick skin type questionnaire to quantify skin tone and will have measurements taken with a colorimeter on the right and left forearms, hands, and fingers to quantify skin tone at the first study visit. Participants will be asked to complete the SSPRO questionnaire at the time of enrollment and every three months for the first 12 months and then every six months until the end of the study. At each study visit, a physician will measure the mRSS, which is a method of quantifying skin fibrosis; SFDI measurements, ultrasound, and durometry will then be done. Skin biopsies will be collected from the forearm of each subject annually. A small amount of blood will also be collected from subjects once per year to explore serum biomarkers of fibrosis.
干预措施: Spatial-frequency domain imaging (SFDI) (Other)
Healthy controls
Participants in this arm will be asked to complete the Fitzpatrick skin type questionnaire to quantify skin tone and will have measurements taken with a colorimeter on the right and left forearms, hands, and fingers to quantify skin tone at the first study visit. At each study visit, SFDI measurements, ultrasound, and durometry will be done. Skin biopsies will be collected from the forearm of each subject annually. A small amount of blood will also be collected from subjects once per year to explore serum biomarkers of fibrosis.
干预措施: Spatial-frequency domain imaging (SFDI) (Other)
结局指标
主要结局
Baseline SFDI measurements of skin thickness
时间窗: baseline
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
6 months SFDI measurements of skin thickness
时间窗: 6 months
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
12 months SFDI measurements of skin thickness
时间窗: 12 months
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
18 months SFDI measurements of skin thickness
时间窗: 18 months
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
24 months SFDI measurements of skin thickness
时间窗: 24 months
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
30 months SFDI measurements of skin thickness
时间窗: 30 months
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
36 months SFDI measurements of skin thickness
时间窗: 36 months
SFDI measurements will be obtained on the right and left fingers, hands, and upper arms and forearms
次要结局
- Serum fibrosis biomarkers, Chemokines that promote fibrosis(baseline and every 12 months up to 36 months)
- histopathological assessments of skin collagen content(baseline and every 12 months up to 36 months)
- Serum fibrosis biomarkers, Pro-inflammatory cytokines involved in immune cell migration(baseline and every 12 months up to 36 months)
- Serum fibrosis biomarkers, Matricellular proteins(baseline and every 12 months up to 36 months)