ClinicalTrials.gg
Sign In
Status unknownNCT06410898Updated May 13, 2024

Assessment of Hypoxia Inducible Factor and Autophagy Related Genes in Patients With Non-Segmental Vitiligo

An interventional study of Punch Biopsy 5mm in Vitiligo, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-13.

Sponsored by Sohag University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The present study will aim to evaluate:

  1. The presence of Hypoxia Inducible Factor in vitiligo patient
  2. Defect of Autophagy Related Genes in vitiligo patient
  3. The cross relation between Autophagy Related Genes and Hypoxia Inducible Factor in the pathogenesis of vitiligo among Egyptian patients in Sohag Governorate
02

Conditions studied

  • Vitiligo

Browse trials for

03

In context

Vitiligo

306 studies on the registry are indexed under Vitiligo; 70 are open to participants now.

This study's planned enrollment of 30 is close to the median of 32 across 235 interventional studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

Sohag University is the lead sponsor of 1,220 studies on the registry; 629 are open to participants now.

Browse Sohag University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    skin biopsy from vitiligo lesion in vitiligo patient

    punch biopsy 5mm from vitiligo patch in vitiligo patient

    Device: Punch Biopsy 5mm

  • Active comparator
    skin biopsy from normal skin in vitiligo patient

    punch biopsy 5mm from normal skin patch in vitiligo patient

    Device: Punch Biopsy 5mm

  • Active comparator
    skin biopsy from normal skin in normal person

    punch biopsy 5mm from normal skin patch in normal person

    Device: Punch Biopsy 5mm

Interventions

  • DevicePunch Biopsy 5mm

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

06

What researchers measure

Primary outcomes

  1. Assessment of Autophagy Related genes in Vitiligo patients

    Assess Autophagy Related genes levels in skin biopsy of vitiligo patient

    Time frame: 2 months

  2. Assessment of Hypoxia Inducible Factor in Vitiligo patients

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

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
  • Sohag University hospitals
    Sohag, Egypt
    Recruiting
08

References and documents

Publications

  • 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. PubMed 32503939 ↗
  • 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. PubMed 36553654 ↗
  • 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. PubMed 33767135 ↗
  • 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. PubMed 22417114 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Jul 2024, 3 months after the start.

Of 59 non-industry interventional studies with no phase under Vitiligo, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 3 months is below that.

Counting every sponsor, half of 63 studies reached it within 15 months; a quarter within 7 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2024
First posted
May 13, 2024
StartActual
Apr 25, 2024
Primary completionEst.
Jul 25, 2024
CompletionEst.
Jul 25, 2024
Last update
May 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06410898
Lead sponsor
Sohag University
Responsible party
Rania Hassan Metwaly (Resident Dermatologist in Akhmim hospital, Sohag University) — Principal investigator
First posted
May 13, 2024
Start date
Apr 25, 2024
Primary completion
Jul 25, 2024 (estimated)
Completion
Jul 25, 2024 (estimated)
Last update
May 13, 2024

Study contacts

Rania H Metwally, Resident
Contact
rania_hassan_post@med.sohag.edu.eg
01018845428
Reham E El-Sharkawy, Professor
Contact
01006809003

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Vitiligo →

Other studies from this sponsor

Sohag University →

Start the discussion