Cutaneous JAK in Vitiligo and Acne Vulgaris.

June 11, 2017 updated by: Yasmin Mostafa Tawfik, Assiut University

Cutaneous JAK Expression in Vitiligo and Acne Vulgaris.

The Janus kinase/signal transducer and activator of transcription (JAK-STAT) cytokine signaling pathway is an emerging area of interest in dermatology, and emerging evidence suggests that this pathway may play a crucial role in pathogenesis of inflammatory skin disorders.

Recent advances on the role of cytokines in the pathophysiology of immune mediated inflammatory diseases lead to the understanding that many pro inflammatory interleukins use JAK/STAT components for signal transduction .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The JAK/STAT signaling pathway transmits information from extracellular chemical signals to the nucleus resulting in DNA transcription. Binding of ligands, such as interferon and interleukins, to their specific transmembrane receptors activate associated JAKs. Phosphorylation of STAT follows, and the phosphorylated STAT translocates to the cell nucleus and activates transcription or suppression of target genes .

The JAK family of non-receptor intracellular tyrosine kinases is comprised of four members, JAK1, JAK2, JAK3 and tyrosine kinase (TyK)2. The JAKs are selectively activated by different receptors and have, therefore, distinct in vivo roles. JAK1 is mainly activated by type II cytokine receptors. JAK2 is crucial in transducing signals for cytokine receptors involved in hematopoiesis (erythropoietin, thrombopoietin and haematopoietic cell development cytokines). JAK3 is mainly expressed in B and T lymphocytes, and TYK2 associates commonly with other JAKs.

Cutaneous JAK overexpression has already been demonstrated in a number of inflammatory skin diseases (ISDs) including psoriasis, lichen planus (LP), atopic dermatitis (AD), pyoderma gangrenosum (PG) and alopecia areata (AA); indicating its crucial role in inflammatory keratinocytes.

Furthermore, the recent discovery of the JAK/STAT signaling pathway opened a new window of opportunity for the treatment of ISDs and promoted the development of drugs that block JAK activation.

JAK inhibitors in oral and topical formulations have shown beneficial results in psoriasis and alopecia areata. Patients suffering from vitiligo might also benefit from JAK inhibition. Recently, significant repigmentation was reported in a patient with vitiligo after treatment with tofacitinib, an oral JAK 1/3 inhibitor . However, the knowledge of the cutaneous JAK involvement in vitiligo is scarce. Similarly, little is known about cutaneous JAK expression in acne vulgaris.

Considering the previous findings, there is a need for further elucidation of the JAK signaling in other skin diseases as vitiligo and acne vulgaris.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A group of 20 patients with vitiligo and 20 patients with acne vulgaris and another control group of 20 age and sex matched healthy volunteers.

Description

Inclusion Criteria:

  • patients with vitiligo and acne vulgaris.

Exclusion Criteria:

  • patients below 12 years of age, or receiving systemic treatments in the last month

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with acne vulgaris
Clinical evaluation including full history taking and dermatological examination will be done for all patients. Assessment of disease severity will be performed using Global acne severity grading for acne vulgaris Skin biopsies will be taken from lesional and non-lesional skin .immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3.
Diagnostic test: skin biopsy

Clinical evaluation including full history taking and dermatological examination will be done for all patients. Assessment of disease severity will be performed using VASI score for vitiligo and Global acne severity grading for acne vulgaris Skin biopsies will be taken from lesional and non-lesional skin of patients as well as controls. immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3.

Additionally, biopsies will be preserved in RNA later solution at -20°C. RNA isolation and real-time qPCR analysis will be performed for measurement of cutaneous JAK1, JAK2 and JAK3 gene expression.
patients with vitiligo
Clinical evaluation including full history taking and dermatological examination will be done . Assessment of disease severity will be performed using VASI score Skin biopsies will be taken from lesional and non-lesional skin .immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3..
Diagnostic test: skin biopsy

Clinical evaluation including full history taking and dermatological examination will be done for all patients. Assessment of disease severity will be performed using VASI score for vitiligo and Global acne severity grading for acne vulgaris Skin biopsies will be taken from lesional and non-lesional skin of patients as well as controls. immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3.

Additionally, biopsies will be preserved in RNA later solution at -20°C. RNA isolation and real-time qPCR analysis will be performed for measurement of cutaneous JAK1, JAK2 and JAK3 gene expression.
control

Skin biopsies will be taken from skin of controls.

. Five micron thick sections will be cut from paraffin blocks for immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3.
Diagnostic test: skin biopsy

Clinical evaluation including full history taking and dermatological examination will be done for all patients. Assessment of disease severity will be performed using VASI score for vitiligo and Global acne severity grading for acne vulgaris Skin biopsies will be taken from lesional and non-lesional skin of patients as well as controls. immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3.

Additionally, biopsies will be preserved in RNA later solution at -20°C. RNA isolation and real-time qPCR analysis will be performed for measurement of cutaneous JAK1, JAK2 and JAK3 gene expression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To analyze the cutaneous JAK expression in vitiligo and acne vulgaris, assess cutaneous JAK expression in relation to disease severity in vitiligo and acne vulgaris compared to controls
Time Frame: 1 year

Skin biopsies will be taken from lesional and non-lesional skin of patients as well as from healthy volunteers as controls.

All biopsies will be derived from untreated skin lesions for a minimum of 15 days before the biopsy The biopsies will be fixed and paraffin embedded. Five micron thick sections will be cut from paraffin blocks for immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3.

Additionally, biopsies will be preserved in RNA later solution at -20°C. RNA isolation and real-time qPCR analysis will be performed for measurement of cutaneous JAK1, JAK2 and JAK3 gene expression.
1 year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Amira Abdel Motaleb, MD, Assiut 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 (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

June 11, 2017

First Submitted That Met QC Criteria

June 11, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 11, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJEIVAA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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