- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06410898
Assessment of Hypoxia Inducible Factor and Autophagy Related Genes in Patients With Non-Segmental Vitiligo
May 7, 2024 updated by: Rania Hassan Metwaly, Sohag University
The present study will aim to evaluate:
- The presence of Hypoxia Inducible Factor in vitiligo patient
- Defect of Autophagy Related Genes in vitiligo patient
- The cross relation between Autophagy Related Genes and Hypoxia Inducible Factor in the pathogenesis of vitiligo among Egyptian patients in Sohag Governorate
Study Overview
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rania H Metwally, Resident
- Phone Number: 01018845428
- Email: rania_hassan_post@med.sohag.edu.eg
Study Contact Backup
- Name: Reham E El-Sharkawy, Professor
- Phone Number: 01006809003
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag University hospitals
-
Contact:
- Magdy M Amin, Professor
- Phone Number: 0934602963
- Email: Portal@med.sohag.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adult >18 years
- With non segmental vitiligo
- A group of participants will be included as a control group
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: skin biopsy from vitiligo lesion in vitiligo patient
punch biopsy 5mm from vitiligo patch in vitiligo patient
|
Disinfect the skin, inject local anesthesia ,insert the punch and extract the biopsy
|
|
Active Comparator: skin biopsy from normal skin in vitiligo patient
punch biopsy 5mm from normal skin patch in vitiligo patient
|
Disinfect the skin, inject local anesthesia ,insert the punch and extract the biopsy
|
|
Active Comparator: skin biopsy from normal skin in normal person
punch biopsy 5mm from normal skin patch in normal person
|
Disinfect the skin, inject local anesthesia ,insert the punch and extract the biopsy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Autophagy Related genes in Vitiligo patients
Time Frame: 2 months
|
Assess Autophagy Related genes levels in skin biopsy of vitiligo patient
|
2 months
|
|
Assessment of Hypoxia Inducible Factor in Vitiligo patients
Time Frame: 2 months
|
Assess level of Hypoxia Inducible factor in skin biopsy of vitiligo patient
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2024
Primary Completion (Estimated)
July 25, 2024
Study Completion (Estimated)
July 25, 2024
Study Registration Dates
First Submitted
May 2, 2024
First Submitted That Met QC Criteria
May 7, 2024
First Posted (Actual)
May 13, 2024
Study Record Updates
Last Update Posted (Actual)
May 13, 2024
Last Update Submitted That Met QC Criteria
May 7, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-24-04-014MS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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