Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545110
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Retinol Binding Protein 4 Protein in Alopecia Areata Treated With Barcitinib
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Retinol Binding Protein 4 Expression and Its Genetic Variants in Severe Alopecia Areata Treated With Barcitinib
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Assess serum and tissue retinol binding protein 4 in patients with severe alopecia areata in correlation with healthy individuals
Estimate genetic profile of retinol binding protein4 in severe alopecia areata patients
Assess possible role of retinol binding protein 4 genetic mutation in response to barcitinib treatment in patients with severe alopecia areata
Estimate genetic profile of retinol binding protein4 in severe alopecia areata patients
Assess possible role of retinol binding protein 4 genetic mutation in response to barcitinib treatment in patients with severe alopecia areata
Detailed Description:
Alopecia areata is an autoimmune disorder characterized by transient non-scarring hair loss and preservation of the hair follicle It is a multifactorial disease in which environmental neuro-endocrinological immunological and genetic factors are involved AA affecting the hair follicle is the most common form through a breakdown in immune privilege of the hair follicle in the anagen hair growth phase by CD4 and CD8 T lymphocytes
Based on the degree of hair loss and variation in clinical presentation AA classified into patchy AA localized areas of hair loss on the scalp andor body totalis AT entire scalp hair loss and universalis AU entire scalp and body hair loss Several studies showed that genes involved in immune response inflammatory diseases infectious diseases The hair loss in AA involves changes in the hair growth cycle resulting in dystrophic anagen hair follicles together with increased frequency of telogen follicles
Retinol binding protein 4 RBP4 is a member of the lipocalin family and the major transport protein of the hydrophobic molecule retinol also known as vitamin A in the circulation Expression of RBP4 is highest in the liver where most of the bodys vitamin A reserves are stored as retinyl esters For the mobilization of vitamin A from the liver retinyl esters are hydrolyzed to retinol which then binds to RBP4 in the hepatocyte The pathogenesis of AA may be related to increased serum retinol-binding protein-4 RBP4 level Its level was found to be increasing in the outer root sheath during late anagen and remained as such throughout catagen RBP4 may contribute to inflammation by stimulating the expression of proinflammatory molecules involved in leukocyte recruitment and adherence to the endothelium
Baricitinib bar i sye ti nib is an orally available specific inhibitor Janus-associated kinases mainly JAK1 and JAK2 that is used to treat moderate-to-severe rheumatoid arthritis and alopecia areata The Janus kinases are critical steps in immune activation as well as in hematopoiesis JAK1 is a critical kinase in the cellular responses of interferon alpha while JAK2 is involved in pathways activated by interferon gamma The immunomodulatory effects of baricitinib have led to its evaluation in several autoimmune conditions interrupt cytokine signaling implicated in the pathogenesis of alopecia areata
Based on the degree of hair loss and variation in clinical presentation AA classified into patchy AA localized areas of hair loss on the scalp andor body totalis AT entire scalp hair loss and universalis AU entire scalp and body hair loss Several studies showed that genes involved in immune response inflammatory diseases infectious diseases The hair loss in AA involves changes in the hair growth cycle resulting in dystrophic anagen hair follicles together with increased frequency of telogen follicles
Retinol binding protein 4 RBP4 is a member of the lipocalin family and the major transport protein of the hydrophobic molecule retinol also known as vitamin A in the circulation Expression of RBP4 is highest in the liver where most of the bodys vitamin A reserves are stored as retinyl esters For the mobilization of vitamin A from the liver retinyl esters are hydrolyzed to retinol which then binds to RBP4 in the hepatocyte The pathogenesis of AA may be related to increased serum retinol-binding protein-4 RBP4 level Its level was found to be increasing in the outer root sheath during late anagen and remained as such throughout catagen RBP4 may contribute to inflammation by stimulating the expression of proinflammatory molecules involved in leukocyte recruitment and adherence to the endothelium
Baricitinib bar i sye ti nib is an orally available specific inhibitor Janus-associated kinases mainly JAK1 and JAK2 that is used to treat moderate-to-severe rheumatoid arthritis and alopecia areata The Janus kinases are critical steps in immune activation as well as in hematopoiesis JAK1 is a critical kinase in the cellular responses of interferon alpha while JAK2 is involved in pathways activated by interferon gamma The immunomodulatory effects of baricitinib have led to its evaluation in several autoimmune conditions interrupt cytokine signaling implicated in the pathogenesis of alopecia areata
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None