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ASSESSMENT OF TRISTETRAPROLIN EXPRESSION IN LESIONAL SKIN OF PATIENTS WITH NON SEGMENTAL VITILIGO

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ClinicalTrials.gov Identifier: NCT05990309
Recruitment Status : Not yet recruiting
First Posted : August 14, 2023
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
marwa khaled mahmoud, Sohag University

Study Description
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Brief Summary:
Vitiligo is characterized by the selective loss of melanocytes, which in turn leads to totally amelanotic, non-scaly, chalky-white macule with distinct margins Vitiligo is the most common depigmenting skin disorder, with an estimated prevalence of 0.5-2% of the population in both adults and children worldwide Tumor necrosis factor (TNF-α), a pro-inflammatory cytokine is necessary for Th1 mediated response and immune homeostasis and the up-regulation of TNF-α can result in chronic inflammatory and autoimmune diseases . previous studies revealed a rise in transcript and protein levels of TNF-α in vitiligo patients The prime location of melanocytes, keratinocytes and fibroblasts is the epidermal microenvironment and these cells are capable of TNF-α expression and secretion TNF-α acts as an autocrine as well as a paracrine manner to suppress the melanocyte growth and proliferation ( Tristetraprolin (TTP) zinc finger protein 36 (ZFP36) is Ribonucleic acid (RNA) binding protein that preferentially binds to Adenylate-uridylate-rich (AU-rich) regions in the 3' untranslated regions (3'UTR) of target genes . Additionally, Tristetraprolin functions by destabilizing mRNAs encoding for oncogenes, cytokines (as TNFα), and chemokines involved in the inflammatory processes, by favoring their degradation and/or preventing their efficient translation The expression of proinflammatory mediator genes is tightly controlled by post-transcriptional regulation, which is mediated by a set of immune-related RNA binding proteins, such as tristetraprolin, Roquin, and Regnase

Condition or disease Intervention/treatment Phase
Non-segmental Vitiligo Diagnostic Test: skin biopsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: ASSESSMENT OF TRISTETRAPROLIN EXPRESSION IN LESIONAL SKIN OF PATIENTS WITH NON SEGMENTAL VITILIGO
Estimated Study Start Date : August 2023
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: non-segmental vitiligo
patients with non-segmental vitiligo
 Diagnostic Test: skin biopsy
skin biopsy for immunohistochemical staining and assessment of tissue expression of tristetraprolin
Active Comparator: control group Diagnostic Test: skin biopsy
skin biopsy for immunohistochemical staining and assessment of tissue expression of tristetraprolin


Outcome Measures
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Primary Outcome Measures :
  1. tristetraprolin [ Time Frame: 12 months ]
    Tristetraprolin (TTP) zinc finger protein 36 (ZFP36) is Ribonucleic acid (RNA) binding protein that preferentially binds to Adenylate-uridylate-rich (AU-rich) regions in the 3' untranslated regions (3'UTR) of target genes (Brooks et al., 2013). Additionally, Tristetraprolin functions by destabilizing mRNAs encoding for oncogenes, cytokines (as TNFα), and chemokines involved in the inflammatory processes, by favoring their degradation and/or preventing their efficient translation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • This study will include adult patients>18 yrs with non -segmental vitiligo attending the dermatology outpatient clinics at Sohag University, Egypt. A group of participants will be included as a control group.This control group will be taken from patients seeking for abdominoplasty in plastic surgery department at Sohag University Hospital.

Exclusion Criteria:

- 1)Pregnancy. 2)Patients with chronic inflammatory skin disorders. 3)Patients on antioxidants or anti-inflammatory drugs. 4)Patients on topical or systemic treatment for vitiligo in the last 4 weeks prior to enrollment in the study.

5)Patients with other autoimmune diseases as thyroiditis. lupus erythematosus and rheumatoid arthritis 6)Patients with diabetes mellitus (DM).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05990309


Contacts
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Contact: marwa k mahmoud, resident 01015429755 marwa_khaled_post@med.sohag.edu.eg
Contact: ramadan s abdou, professor

Sponsors and Collaborators
Sohag University
More Information
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Publications:

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Responsible Party: marwa khaled mahmoud, Resident AT DERMATOLOGY department-sohag hospital university, Sohag University
ClinicalTrials.gov Identifier: NCT05990309    
Other Study ID Numbers: Soh-Med-23-07-11MS
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases