Natural History and Pathogenesis of Alopecia in Children and Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Describe the natural history of alopecia based on demographics, whole exome sequencing, and microbiome and immunologic signals
研究概览
简要总结
Background:
Alopecia is the loss of hair or lack of hair growth. It is often related to an immune disorder that disrupts the growth of hair. Hair loss can affect a person s physical and mental health. The causes of alopecia are not well understood. This natural history study will examine causes of alopecia so better treatments can be developed.
Objective:
To learn why some people have alopecia. This study will look at factors related to genes, the immune system, and the bacteria, viruses, and fungi that live on the skin.
Eligibility:
People aged 2 years and older with immune-mediated alopecia that affects 50% of their scalp hair.
Design:
Participants will have at least 1 visit to the clinic. Some will have follow-up visits once a year for up to 5 years. Each visit will last 2 to 4 hours.
Participants will have a physical exam. They will have blood drawn from a vein. They will answer questions about the medications they take, their allergies, and their family history. Photographs of their skin and scalp will be taken. Soft cotton swabs will be rubbed on their skin to pick up organisms that live there.
Two pieces of skin from the scalp will be cut away. The pieces will be no more than a quarter of an inch in size. The area will first be numbed with an injectable anesthetic. The wound will be closed with stitches or gel foam. The biopsy is optional in children younger than 12.
Participants will take a questionnaire about how hair loss affects their quality of life.
详细描述
Study Description:
This is a study to detail the characteristics (genetic, immunologic, biological and demographic) of individuals who present in childhood and adulthood with alopecia and how alopecia impacts skin and systemic symptoms.
Objectives:
Primary objective: Comprehensively evaluate patients with immune mediated alopecia from clinical, microbiome, immunologic and genetic standpoint to understand the factors that contribute to clinical phenotypes.
Secondary objective: To follow patients with immune-mediated alopecia to see how disease impacts local skin microbiome, immune system changes and autoimmune and other comorbidities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Stated willingness to comply with study procedures including skin biopsy of the scalp (except in those under the age of 12 years) and availability for the duration of the study
- •Willing to avoid using antibacterial cleansers for 1 week prior to sampling
- •Male or female, aged 2 years and older
- •Clinical Diagnosis of immune- mediated alopecia
- •Ability of subject or Parent/legal guardian to understand and the willingness to sign a written informed consent document.
排除标准
- •Non-immune mediated alopecia including androgenetic alopecia, radiation induced alopecia, trauma induced alopecia, chemotherapy induced alopecia
- •Concomitant medical, surgical, or other conditions for which adequate facilities or funds are not available to support their care at the NIH.
- •Any other co-existing condition/circumstances that would make a subject unsuitable to participate in the study, as deemed by the investigators.
- •Pregnant women
研究组 & 干预措施
Patient
Male and female ages 2-45 years old
结局指标
主要结局
Describe the natural history of alopecia based on demographics, whole exome sequencing, and microbiome and immunologic signals
时间窗: 5 years
次要结局
- Explore immune system, microbiome signals during flares and quiescence as well as during therapy(5 years)