VitiligoNCT06410898
Assessment of Hypoxia Inducible Factor and Autophagy Related Genes in Patients With Non-Segmental Vitiligo
A study testing Punch Biopsy 5mm in people with Vitiligo, run by Sohag University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- Punch Biopsy 5mm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2024to 25 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult >18 years
- With non segmental vitiligo
- A group of participants will be included as a control group
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Reham E El-Sharkawy, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor, 0934602963, portal@med.sohag.edu.eg
About this study
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
- Conditions
- Vitiligo
- Being tested
- Punch Biopsy 5mm
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punch Biopsy 5mmDevice
Disinfect the skin, inject local anesthesia ,insert the punch and extract the biopsy
| Study group | Role | What they receive |
|---|---|---|
| skin biopsy from vitiligo lesion in vitiligo patient | Active comparator | punch biopsy 5mm from vitiligo patch in vitiligo patient Receives: Device: Punch Biopsy 5mm |
| skin biopsy from normal skin in vitiligo patient | Active comparator | punch biopsy 5mm from normal skin patch in vitiligo patient Receives: Device: Punch Biopsy 5mm |
| skin biopsy from normal skin in normal person | Active comparator | punch biopsy 5mm from normal skin patch in normal person Receives: Device: Punch Biopsy 5mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Autophagy Related genes in Vitiligo patients
Assess Autophagy Related genes levels in skin biopsy of vitiligo patient
Measured: 2 months
Assessment of Hypoxia Inducible Factor in Vitiligo patients
Assess level of Hypoxia Inducible factor in skin biopsy of vitiligo patient
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start25 Apr 2024
- Primary completion25 Jul 2024 (estimated)
- Study completion25 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hassan Metwaly, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410898
- Sponsor's protocol ID
- Soh-Med-24-04-014MS
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 32503939Artika 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 36553654Bastonini 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 33767135Ezzedine 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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hypoxia Inducible Factor and Autophagy Related Genes in Patients With Non-Segmental Vitiligo
- ClinicalTrials.gov ID
- NCT06410898
- Acronym / sponsor ID
- Soh-Med-24-04-014MS
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 25 Jul 2024 (estimated)
- Study completion
- 25 Jul 2024 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| skin biopsy from vitiligo lesion in vitiligo patient | Active comparator | Device: Punch Biopsy 5mmpunch biopsy 5mm from vitiligo patch in vitiligo patient |
| skin biopsy from normal skin in vitiligo patient | Active comparator | Device: Punch Biopsy 5mmpunch biopsy 5mm from normal skin patch in vitiligo patient |
| skin biopsy from normal skin in normal person | Active comparator | Device: Punch Biopsy 5mmpunch biopsy 5mm from normal skin patch in normal person |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult >18 years
- With non segmental vitiligo
- A group of participants will be included as a control group
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Punch Biopsy 5mmDisinfect the skin, inject local anesthesia ,insert the punch and extract the biopsy | Device | skin biopsy from normal skin in normal person, skin biopsy from normal skin in vitiligo patient, skin biopsy from vitiligo lesion in vitiligo patient |
Primary outcome
Assessment of Autophagy Related genes in Vitiligo patients
Time frame: 2 months
Assess Autophagy Related genes levels in skin biopsy of vitiligo patient
Assessment of Hypoxia Inducible Factor in Vitiligo patients
Time frame: 2 months
Assess level of Hypoxia Inducible factor in skin biopsy of vitiligo patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 32503939Agarwal 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.
- Background: PubMed 36553654Artika 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.
- Background: PubMed 33767135Bastonini 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.
- Background: PubMed 22417114Ezzedine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham E El-Sharkawy, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Punch Biopsy 5mm in people with Vitiligo, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania H Metwally, Resident (01018845428, rania_hassan_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Autophagy Related genes in Vitiligo patients (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06410898, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.