Non-segmental VitiligoNCT05990309
ASSESSMENT OF TRISTETRAPROLIN EXPRESSION IN LESIONAL SKIN OF PATIENTS WITH NON SEGMENTAL VITILIGO
A study testing skin biopsy in people with Non-segmental Vitiligo, run by Sohag University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-segmental Vitiligo
- What is being tested?
- skin biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Aug 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 5)Patients with other autoimmune diseases as thyroiditis. lupus erythematosus and rheumatoid arthritis 6)Patients with diabetes mellitus (DM).
Trial locations and contacts
No sites are listed yet.
ramadan s abdou, professor contact
About this study
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
- Conditions
- Non-segmental Vitiligo
- Being tested
- skin biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyDiagnostic test
skin biopsy for immunohistochemical staining and assessment of tissue expression of tristetraprolin
| Study group | Role | What they receive |
|---|---|---|
| non-segmental vitiligo | Active comparator | patients with non-segmental vitiligo Receives: Diagnostic Test: skin biopsy |
| control group | Active comparator | Not described Receives: Diagnostic Test: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 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 Non-segmental 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa khaled mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990309
- Sponsor's protocol ID
- Soh-Med-23-07-11MS
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22453596Alikhan 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.
PubMed 21839315Alkhateeb 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.
PubMed 12753387Brooks 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.
PubMed 23428348
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF TRISTETRAPROLIN EXPRESSION IN LESIONAL SKIN OF PATIENTS WITH NON SEGMENTAL VITILIGO
- ClinicalTrials.gov ID
- NCT05990309
- Acronym / sponsor ID
- Soh-Med-23-07-11MS
- Conditions
- Non-segmental Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 14 Aug 2023 (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.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-segmental vitiligo | Active comparator | Diagnostic Test: skin biopsypatients with non-segmental vitiligo |
| control group | Active comparator | Diagnostic Test: skin biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
- 5)Patients with other autoimmune diseases as thyroiditis. lupus erythematosus and rheumatoid arthritis 6)Patients with diabetes mellitus (DM).
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 |
|---|---|---|
| skin biopsyskin biopsy for immunohistochemical staining and assessment of tissue expression of tristetraprolin | Diagnostic test | control group, non-segmental vitiligo |
Primary outcome
tristetraprolin
Time frame: 12 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 22453596Alghamdi 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.
- Background: PubMed 21839315Alikhan 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.
- Background: PubMed 12753387Alkhateeb 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.
- Background: PubMed 23428348Brooks 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.
- Individual participant dataSharing planned: Undecided
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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.
ramadan s abdou, professor contact
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy in people with Non-segmental Vitiligo, run by Sohag University.
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 1 inclusion and 2 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 marwa k mahmoud, resident (01015429755, marwa_khaled_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?
tristetraprolin (time frame: 12 months). 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 NCT05990309, 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 14 Aug 2023.