Polymorphism of Janus Kinase 1 and 2 (JAK 1&2) in Patients With Alopecia Areata

May 12, 2023 updated by: Susanna Fayez Fanos, Sohag University

Introduction Alopecia areata (AA) is a complex inflammatory disease characterized by cellular infiltration of T- lymphocytes targeting hair follicles, disrupting the anagen phase, with spontaneous remission, recurrence, and exacerbation, making it very unpredictable and emotionally disturbing . It affects nearly 1-2% of the general population with a lifetime risk of 2%, The onset of AA might be at any age; however, most patients develop the disease before 40 years of age . Early-onset AA (a mean age of onset at 5-10 years) predominantly presents as a more severe subtype, such as alopecia universalis . Alopecia areata presents clinically as a non-scarring patchy hair loss primarily on the scalp, and/or other hairy areas and may progress to total scalp hair loss (alopecia totalis, AT ) or complete body hair loss (alopecia universalis, AU ) . Approximately 5- 10% of AA patients will progress into AT/AU . The course of AA varies greatly, the strongest predictors of a poor prognosis include AT, AU, or ophiasis pattern hair loss, as well as earlier age of onset . Severe and recurrent AA disturbs quality of life of patients and may also lead to depression, changed self-image,and interferes with social activities . Currently, the hypotheses for AA development mostly focus on the collapse of immune privilege properties of the hair follicles(HFs) and the nature of self-antigen presentation (follicular antigens) that result in the induction and subsequent attack of activated lymphocytes . Activation of the lymphocytes mainly CD8+NKG2D+induces release of severalTh1 cytokines; interleukin (IL)-1α , IL-1β , and tumor necrosis factor (TNF) alpha, capable of inhibiting (HF) growth with early termination of anagen . AA is a polygenic disorder in which several major genes dictate susceptibility to disease, up to 28% of patients report at least one affected family member, monozygotic twins have exhibited similar times of onset and patterns of hair loss.

Genes loci for Human leucocyte antigens (HLA)DRB1* 1104 and DQB1* 03 are detected in patients with AA. The Janus kinases (JAKs) and signal transducer and activator of transcription (STAT); (JAK/STAT) pathway play an important role in inflammatory processes as they are involved in signaling for over 50 cytokines and growth factors. The JAK/STAT pathway transduces multiple extracellular signals involved in cell proliferation, differentiation, migration, and apoptosis .

The JAK family is constituted by four types of cytoplasmic tyrosine kinases:

JAK1, JAK2, JAK3, and TYK2 . STAT, of which there are seven different subtypes (STAT1, STAT2, STAT3, STAT4, STAT5a, STAT5b, and STAT6) (17), is the other fundamental component of the cascade . After being phosphorylated by JAK, STAT translocates to the nucleus to induce the transcription of specific genes. Alterations in the JAK/STAT pathway have been related to the pathophysiology of atopic dermatitis (AD), vitiligo, and AA.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Essam El Din A Nada, Professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University hospitals
        • Contact:
          • Magdy M Amin, professor

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All types of AA.

Exclusion Criteria:

  • 1. Pregnancy . 2. Lactation . 3. Systemic diseases . 4. Dermatological disease as vitiligo , psoriasis , atopy . 5. Patient on skin medication affect hair growth as chemotherapy , antithyroid drugs .

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
Under complete sterile precautions, 3mL of blood will be withdrawn by venipuncture and put in EDTA tube; DNA extraction will be done after centrifugation and used for genotyping assay of (JAK 1 and JAK2) gene with the polymerase chain reaction(PCR).
Genetic: Janus Kinase 1 and 2
Under complete sterile precautions, 3mL of blood will be withdrawn by venipuncture and put in EDTA tube; DNA extraction will be done after centrifugation and used for genotyping assay of (JAK 1 and JAK2) gene with the polymerase chain reaction(PCR).
Active Comparator: cases
Under complete sterile precautions, 3mL of blood will be withdrawn by venipuncture and put in EDTA tube; DNA extraction will be done after centrifugation and used for genotyping assay of (JAK 1 and JAK2) gene with the polymerase chain reaction(PCR).
Genetic: Janus Kinase 1 and 2
Under complete sterile precautions, 3mL of blood will be withdrawn by venipuncture and put in EDTA tube; DNA extraction will be done after centrifugation and used for genotyping assay of (JAK 1 and JAK2) gene with the polymerase chain reaction(PCR).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
janus kinase 1 and 2 (JAK 1&2) polymorphism is a risk factor for development of alopecia areata .
Time Frame: 12 months
different janus kinase 1 and 2 (JAK 1&2) genotypes in alopecia areata in comparison to healthy control.
12 months

Collaborators and Investigators

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

Sponsor

Sohag 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)

April 30, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-04-08MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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 Janus Kinase 1 and 2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe