Retinol Binding Protein 4 Protein in Alopecia Areata Treated With Barcitinib

August 6, 2024 updated by: Marwa Alyan Abd-elaziz Mohammed, South Valley University

Retinol Binding Protein 4 Expression and Its Genetic Variants in Severe Alopecia Areata Treated With Barcitinib.

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 .

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 and/or 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 body's 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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • الكيلو 6 Qena - Safaga Rd, Qena, Qena Governorate
      • Qinā, الكيلو 6 Qena - Safaga Rd, Qena, Qena Governorate, Egypt, +20963211279
        • South Valley University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients at least 12 years old not more than 60 with severe alopecia areata, multiple or /with not responding to usual treatment

Exclusion Criteria:

  • Patients with scarring alopecia.
  • Patients less than 12 years old or more than 60.
  • Patients with active inflammatory disease or immuncompromised.
  • Patients with infection or malignancy .
  • Patients with antiepileptic drugs or psychotics .
  • Pregnancy and lactation .
  • Patients with abnormal lipid profile.
  • Patients with bleeding or thrombotic tendency.
  • Patients taking other JAK inhibitors or cyclosporine or immunosuppressive drugs.
  • Patients with active herpes zoster or have tendency for recurrence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
60 patient with sever alopecia areata
Drug: Baricitinib Oral Tablet
Baricitinib 2/4mg giving to patients with sever alopecia areata after assessment Retinol Binding Protein 4 and its genetic variations.
Placebo Comparator: group B
60 healthy individuals
Drug: Baricitinib Oral Tablet
Baricitinib 2/4mg giving to patients with sever alopecia areata after assessment Retinol Binding Protein 4 and its genetic variations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess serum and tissue retinol binding protein 4 in patients with severe alopecia
Time Frame: baseline
Assess serum and tissue retinol binding protein 4 in patients with severe alopecia in serum and tissue samples in response to Baricitinib .
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate genetic profile of retinol binding protein4 in severe alopecia areata patients
Time Frame: baseline
Estimate genetic variations of Retinol binding protein 4 in blood samples before and after Baricitinib.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Study Director: Mostafa Adam Ali El Tieb, professor, Aswan University
  • Study Director: Mohamed Hosny Hassan, professor, South Valley University
  • Study Director: Eisa Mohammed Hegazy, professor, South Valley University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBP4 in alopecia areata

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alopecia Areata

Clinical Trials on Baricitinib Oral Tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe