The Role of Bacterial Toxins in Human Skin Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To determine the molecular mechanisms by which cytokines in atopic dermatitis skin alters differentiation of skin keratinocytes
研究概览
简要总结
Atopic dermatitis and psoriasis are two skin diseases often associated with bacterial infections and inflammation. Studies indicate that skin cells from these patients may have some changes that make these patients more susceptible to bacterial infections. Inflammatory environment may have an effect on the function of skin cells.
The purpose of this study is to learn more about skin cells (keratinocytes and fibroblasts) and how they regulate skin barrier function. To study this we need to establish skin cells that can be grown in the laboratory. We will use small skin biopsies from patients with atopic dermatitis, psoriasis and healthy people as a source of these cells. Since these skin cells have a limited lifetime when grown in laboratory as part of the project we would like to modify them, which allows them to grow for long time in the research laboratory. Some of the collected skin biopsies and isolated skin cells will be used to examine what gene products they make.
详细描述
Visit 1 (if needed). Study subjects will be asked to read and sign the informed consent. At that time the study inclusion and exclusion criteria for the study will be reviewed. Subject will be given instructions to stop taking certain medications for 7 days prior to the next study visit. Alternatively, if Visit 1 will be done over the phone, subjects may be contacted via phone using a phone script to provide instructions for stopping these medications. In this case, the informed consent will be obtained by the subject at visit 2 prior to any study procedures being done.
If the subject takes occasional Aspirin (not taken daily), it will need to be withheld for seven days prior to visit 2.
If the subject takes oral antihistamines, it will need to be withheld for seven days prior to the subject's first appointment.
If the subject takes oral antibiotics, inform the subject the appointment can be scheduled seven days after their last dose of antibiotic has been taken.
If the subject takes topical medications including (but not restricted to), cyclosporine, Elidel, Protopic, topical corticosteroids and topical antibiotics, it will need to be withheld seven days prior to the subject's first appointment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •If subjects takes occasional Aspirin (not taken daily), it will need to be withheld for seven days prior to Visit
- •If subjects takes oral antihistamines, it will need to be withheld for seven days prior to the subject's first appointment
- •If subjects takes topical medications including (but not restricted to), cyclosporine, Elidel, Protopic, topical corticosteroids and topical antibiotics, it will need to withheld seven days prior to the subject's first appointment.
排除标准
- •Women can not be pregnant or become pregnant during the study
- •Oral corticosteroids:
- •Any systemic immunosuppressive or immunomodulatory medication in the last 28 days.
- •Patients who have received immunotherapy in the past year.
- •Patients using anxiolytics or antidepressants
- •Antiviral therapies
- •Anticoagulants
- •Allergic to lidocaine
- •Daily Aspirin use
结局指标
主要结局
To determine the molecular mechanisms by which cytokines in atopic dermatitis skin alters differentiation of skin keratinocytes
时间窗: one year
次要结局
未报告次要终点
研究者
Donald Leung, MD, PhD
Principal Investigator
National Jewish Health