NCT06410898

Brief Summary

The present study will aim to evaluate:

  1. 1.The presence of Hypoxia Inducible Factor in vitiligo patient
  2. 2.Defect of Autophagy Related Genes in vitiligo patient
  3. 3.The cross relation between Autophagy Related Genes and Hypoxia Inducible Factor in the pathogenesis of vitiligo among Egyptian patients in Sohag Governorate

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 25, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

May 2, 2024

Last Update Submit

May 7, 2024

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (2)

  • Assessment of Autophagy Related genes in Vitiligo patients

    Assess Autophagy Related genes levels in skin biopsy of vitiligo patient

    2 months

  • Assessment of Hypoxia Inducible Factor in Vitiligo patients

    Assess level of Hypoxia Inducible factor in skin biopsy of vitiligo patient

    2 months

Study Arms (3)

skin biopsy from vitiligo lesion in vitiligo patient

ACTIVE COMPARATOR

punch biopsy 5mm from vitiligo patch in vitiligo patient

Device: Punch Biopsy 5mm

skin biopsy from normal skin in vitiligo patient

ACTIVE COMPARATOR

punch biopsy 5mm from normal skin patch in vitiligo patient

Device: Punch Biopsy 5mm

skin biopsy from normal skin in normal person

ACTIVE COMPARATOR

punch biopsy 5mm from normal skin patch in normal person

Device: Punch Biopsy 5mm

Interventions

Punch Biopsy 5mmDEVICE

Disinfect the skin, inject local anesthesia ,insert the punch and extract the biopsy

skin biopsy from normal skin in normal personskin biopsy from normal skin in vitiligo patientskin biopsy from vitiligo lesion in vitiligo patient

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult \>18 years
  • With non segmental vitiligo
  • A group of participants will be included as a control group

You may not qualify if:

  • Pregnancy
  • Patient with chronic inflammatory skin disorders
  • patient on anti-oxidant or anti-inflammatory drugs
  • patient on topical or systemic treatment for vitiligo in last 4 weeks
  • patients with other autoimmune diseases
  • patients with diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

RECRUITING

Related Publications (4)

  • Agarwal S, Ganesh S. Perinuclear mitochondrial clustering, increased ROS levels, and HIF1 are required for the activation of HSF1 by heat stress. J Cell Sci. 2020 Jul 9;133(13):jcs245589. doi: 10.1242/jcs.245589.

    PMID: 32503939BACKGROUND

  • Artika IM, Dewi YP, Nainggolan IM, Siregar JE, Antonjaya U. Real-Time Polymerase Chain Reaction: Current Techniques, Applications, and Role in COVID-19 Diagnosis. Genes (Basel). 2022 Dec 16;13(12):2387. doi: 10.3390/genes13122387.

    PMID: 36553654BACKGROUND

  • Bastonini E, Kovacs D, Raffa S, Delle Macchie M, Pacifico A, Iacovelli P, Torrisi MR, Picardo M. A protective role for autophagy in vitiligo. Cell Death Dis. 2021 Mar 25;12(4):318. doi: 10.1038/s41419-021-03592-0.

    PMID: 33767135BACKGROUND

  • Ezzedine K, Lim HW, Suzuki T, Katayama I, Hamzavi I, Lan CC, Goh BK, Anbar T, Silva de Castro C, Lee AY, Parsad D, van Geel N, Le Poole IC, Oiso N, Benzekri L, Spritz R, Gauthier Y, Hann SK, Picardo M, Taieb A; Vitiligo Global Issue Consensus Conference Panelists. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012 May;25(3):E1-13. doi: 10.1111/j.1755-148X.2012.00997.x.

    PMID: 22417114BACKGROUND

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Rania H Metwally, Resident

CONTACT

01018845428rania_hassan_post@med.sohag.edu.eg

Reham E El-Sharkawy, Professor

CONTACT

01006809003

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Dermatologist in Akhmim hospital

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 13, 2024

Study Start

April 25, 2024

Primary Completion

July 25, 2024

Study Completion

July 25, 2024

Last Updated

May 13, 2024

Record last verified: 2024-05

Locations

EG(1)