Assessment of Serum Levels of Janus Kinase 1 and 2 in Patients With Cholinergic Urticaria

NCT06201780 | Unknown

• 1 other identifier: soh-Med-23-12-07MS
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Cholinergic Urticaria (CholU) is as a subtype of CIndU caused by an increase in the core body temperature, such as to activate the sweating reflex. It can occur in response to physical exercise, hot bathing and/or emotional stress. Clinically it appears as pinpointing and highly pruritic wheals with surrounding erythema, CholU can be accompanied by severe symptoms such as angioedema, respiratory symptoms or anaphylaxi CholU is frequently associated with atopic dermatitis (AD) The JAK-STAT is a mast cell (MC) signaling pathway activated downstream of IgE and IL-3 with important roles in MC homeostasis via regulation of proliferation, survival, and release of mediators. JAK-STAT activation is associated with polarization toward Th2, B cell isotype switching to IgE production, and IgE-dependent degranulation and cytokine release . Because both IL-4 and IL-13 use the IL-4Rα as a receptor component, these cytokines activate any common signaling pathways. Both of these cytokines use Janus kinases (JAKs) to initiate signaling and activate signal transducer and activator of transcription-6 (STAT6), which is a transcription factor required for many of their biologic functions. The non-receptor protein tyrosine kinases JAK1 and JAK3 associate with the IL-4Rα and γC, respectively. The binding of IL-4 to its receptor induces the transphosphorylation of JAK1 and JAK3, an event that activates these kinases and thereby initiates the early events of signal transduction .

Conditions

Cholinergic Urticaria

Outcome Measures

Primary Outcomes (1)

• serum levels of janus kinase 1

  assessment of serum levels of janus kinase 1

  1 year

Secondary Outcomes (1)

• serum levels of janus kinase 2

  1 year

Study Arms (2)

cases group

ACTIVE COMPARATOR

group of cases with cholinergic urticaria

Diagnostic Test: serum levels of Janus Kinase 1and 2

control group

ACTIVE COMPARATOR

control group not have cholinergic urticaria

Diagnostic Test: serum levels of Janus Kinase 1and 2

Interventions

serum levels of Janus Kinase 1and 2 DIAGNOSTIC_TEST

assessment of serum levels of Janus Kinase 1and 2 by ELISA

cases group; control group

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The study will include 45 adult patients complaining of CholU as well as 45 healthy controls.

You may not qualify if:

• Patients with one or more of the following criteria will be excluded:
• Pregnancy and lactation.
• Patients with systemic diseases especially those with autoimmune diseases and infections.
• Patients with skin diseases.
• Patients on medications such as: antibiotics, non-steroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, anticonvulsants, penicillin, combined oral contraceptives.
• Patient refusal

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• Altrichter S, Koch K, Church MK, Maurer M. Atopic predisposition in cholinergic urticaria patients and its implications. J Eur Acad Dermatol Venereol. 2016 Dec;30(12):2060-2065. doi: 10.1111/jdv.13765. Epub 2016 Jun 21.

  PMID: 27324252 BACKGROUND

• Altrichter S, Salow J, Ardelean E, Church MK, Werner A, Maurer M. Development of a standardized pulse-controlled ergometry test for diagnosing and investigating cholinergic urticaria. J Dermatol Sci. 2014 Aug;75(2):88-93. doi: 10.1016/j.jdermsci.2014.04.007. Epub 2014 May 1.

  PMID: 24837213 BACKGROUND

• Burchett JR, Dailey JM, Kee SA, Pryor DT, Kotha A, Kankaria RA, Straus DB, Ryan JJ. Targeting Mast Cells in Allergic Disease: Current Therapies and Drug Repurposing. Cells. 2022 Sep 27;11(19):3031. doi: 10.3390/cells11193031.

  PMID: 36230993 BACKGROUND

• Fricke J, Avila G, Keller T, Weller K, Lau S, Maurer M, Zuberbier T, Keil T. Prevalence of chronic urticaria in children and adults across the globe: Systematic review with meta-analysis. Allergy. 2020 Feb;75(2):423-432. doi: 10.1111/all.14037. Epub 2019 Oct 11.

  PMID: 31494963 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident-Dermatology department-sohag hospital university

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 11, 2024
• Study Start: December 15, 2023
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

EG (1)