NCT05990309

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 6, 2023

Last Update Submit

August 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • tristetraprolin

    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

    12 months

Study Arms (2)

non-segmental vitiligo

ACTIVE COMPARATOR

patients with non-segmental vitiligo

Diagnostic Test: skin biopsy

control group

ACTIVE COMPARATOR
Diagnostic Test: skin biopsy

Interventions

skin biopsyDIAGNOSTIC_TEST

skin biopsy for immunohistochemical staining and assessment of tissue expression of tristetraprolin

control groupnon-segmental vitiligo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Alghamdi KM, Khurrum H, Taieb A, Ezzedine K. Treatment of generalized vitiligo with anti-TNF-alpha Agents. J Drugs Dermatol. 2012 Apr;11(4):534-9.

    PMID: 22453596BACKGROUND
  • Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.

    PMID: 21839315BACKGROUND
  • Alkhateeb A, Fain PR, Thody A, Bennett DC, Spritz RA. Epidemiology of vitiligo and associated autoimmune diseases in Caucasian probands and their families. Pigment Cell Res. 2003 Jun;16(3):208-14. doi: 10.1034/j.1600-0749.2003.00032.x.

    PMID: 12753387BACKGROUND
  • Brooks SA, Blackshear PJ. Tristetraprolin (TTP): interactions with mRNA and proteins, and current thoughts on mechanisms of action. Biochim Biophys Acta. 2013 Jun-Jul;1829(6-7):666-79. doi: 10.1016/j.bbagrm.2013.02.003. Epub 2013 Feb 18.

    PMID: 23428348BACKGROUND

Central Study Contacts

marwa k mahmoud, resident

CONTACT

ramadan s abdou, professor

CONTACT

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 AT DERMATOLOGY department-sohag hospital university

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 14, 2023

Study Start

August 1, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

August 14, 2023

Record last verified: 2023-08