Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05502796
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2022-08-13
Brief Title:
Natural History and Pathogenesis of Alopecia in Children and Adults
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History and Pathogenesis of Alopecia in Children and Adults
Status:
RECRUITING
Status Verified Date:
2024-06-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
Tertiary objectives To develop prognostic biomarkers that help predict the risk of severity and progression in patients with alopecia
Endpoints
1 Record demographics including age sex age of onset severity of disease based on clinical examination concomitant autoimmune disease personal history of other medical disease including anxiety and depression family history of autoimmune and medical disease
2 Whole genome sequencing to identify variations in the protein-coding region of any gene that may be disease causing
3 Assess peripheral blood and local scalp skin to assess immunogenicity of disease by using leukocyte subset analysis using flow cytometry markers of disease using cytokine signaling assays and single cell RNA sequencing
4 Define skin microbiome using sequencing at baseline and with time
5 Identify potential biomarkers of disease progression or severity that may impact therapeutic choices
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
Tertiary objectives To develop prognostic biomarkers that help predict the risk of severity and progression in patients with alopecia
Endpoints
1 Record demographics including age sex age of onset severity of disease based on clinical examination concomitant autoimmune disease personal history of other medical disease including anxiety and depression family history of autoimmune and medical disease
2 Whole genome sequencing to identify variations in the protein-coding region of any gene that may be disease causing
3 Assess peripheral blood and local scalp skin to assess immunogenicity of disease by using leukocyte subset analysis using flow cytometry markers of disease using cytokine signaling assays and single cell RNA sequencing
4 Define skin microbiome using sequencing at baseline and with time
5 Identify potential biomarkers of disease progression or severity that may impact therapeutic choices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000827-AR | None | None | None |