Serum Gasdermin D in VitiligoNCT06584643
Evaluation of Serum Gasdermin D Level As a Potential Biomarker of Disease Activity in Vitiligo Patients
An observational study of Serum Gasdermin D in Vitiligo, run by Assiut University.
Trial summary
Assessment the serum level of Gasdermin D level in vitiligo patients. Correlate its level with disease activity scores using Vitiligo Area Severity Index (VASI) and Vitiligo Disease Activity (VIDA) scores and with different disease parameters. Read more about this study
- Who is it for?
- Ages 10 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Serum Gasdermin D in Vitiligo
- What is being tested?
- gasdermin d
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Dec 2025
- Phase
- Observational
- 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 10 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: For every patient, a full history will be taken recording age, gender, education, residence, special habits, age at onset of vitiligo, duration of vitiligo, stability of vitiligo and family history. A detailed cutaneous examination will be performed including skin phototype, Koebner phenomenon, vitiligo clinical type, leukotrichia, Vitiligo Area Severity Index (VASI) and Vitiligo Disease Activity (VIDA) scores.
Who may be able to join
- All clinically diagnosed cases of vitiligo (segmental and non-segmental).
Who cannot join
- patients with inflammatory diseases.
- patients with autoimmne diseases.
- patients with neurodegenerative diseases.
- patients with HIV or COVID19 infection or any other type of infections.
- patients with systemic diseases as liver diseases or having tumors.
- patients who received systemic treatment in the last 3 months or topical treatment 1 month prior to the study.
Trial locations and contacts
No sites are listed yet.
About this study
Assessment the serum level of Gasdermin D level in vitiligo patients. Correlate its level with disease activity scores using Vitiligo Area Severity Index (VASI) and Vitiligo Disease Activity (VIDA) scores and with different disease parameters.
Read the detailed description
Vitiligo, a common depigmenting skin disorder, has an estimated prevalence of 0.5-2% of the population worldwide. The disease is characterized by the selective loss of melanocytes which results in typical nonscaly, chalky-white macules. In recent years, considerable progress has been made in our understanding of the pathogenesis of vitiligo which is now clearly classified as an autoimmune disease .
The destruction of melanocyte is thought to be of multifactorial causation. Genome-wide associated studies have identified single-nucleotide polymorphisms in a panel of susceptible loci as risk factors in melanocyte death. But vitiligo onset can't be solely attributed to a susceptive genetic background .
Oxidative stress triggered by elevated levels of reactive oxygen species accounts for melanocytic molecular and organelle dysfunction, in addition to the self-responsive immune function directly contributes to the bulk of melanocyte deaths in vitiligo .
Moreover, apoptosis is the most extensively documented way of melanocyte demise, with few melanocytes undergo necrosis. But forms of cell death are not merely restricted to apoptosis and necrosis. Cells may die from accidental cell death (ACD) or regulated cell death (RCD). ACD, like necrosis, is biologically uncontrolled, whereas RCD (apoptosis, necroptosis, pyroptosis, oxeiptosis, ferroptosis, parthanatos, etc.) involves precise signaling cascade and molecular mechanisms .
Pyroptosis is mechanistically distinct from other forms of cell death with gasdermin D (GSDMD) and caspase-1/4/5/11 activation as its defining feature . Upon being stimulated by damage-associated molecular patterns molecules (DAMPs), pathogen-associated molecular patterns molecules or altered homeostasis, caspases are activated to cleave the downstream GSDMD. GSDMD fragment with membrane pore-forming activity yields plasma membrane rupture, cytosolic content release, and concurrent cell swelling and lysis
Gasdermins belong to the pore-forming protein family and consist of six gasdermin proteins, including gasdermins A-E. The members of the gasdermin family have two domains: an N-terminal domain and a C-terminal domain linked by a flexible peptide. Upon activation, the cleaved N-terminal domain is responsible for inducing pyroptosis . GSDMD, the most extensively studied executive pyroptosis-executing protein with the clearest mechanism.
In a previous study, scRNA-seq datasets of skin-derived cells from healthy donors and patients with vitiligo were analysed. Results demonstrated that CASP1, CASP4, CASP6, CASP8, and GSDMD expression was significantly upregulated in melanocytes of patients with vitiligo. These results indicated that pyroptosis signaling is an important pathway in the development of vitiligo .
To the best of our knowledge, no previous studies have evaluated the serum level of Gasdermin D as a potential biomarker in vitiligo patients.
- Conditions
- Serum Gasdermin D in Vitiligo
- Being tested
- gasdermin d
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gasdermin dDiagnostic test
evaluation of serum gasdermin d in vitligo patients and healthy controls
| Study group | Role | What they receive |
|---|---|---|
| case group | For every patient, a full history will be taken recording age, gender, education, residence, special habits, age at onset of vitiligo, duration of vitiligo, stability of vitiligo and family history. A detailed cutaneous examination will be performed including skin phototype, Koebner phenomenon, vitiligo clinical type, leukotrichia, Vitiligo Area Severity Index (VASI) and Vitiligo Disease Activity (VIDA) scores. Receives: Diagnostic Test: gasdermin d | |
| healthy control | age and gender matched healthy volunteers as controls Receives: Diagnostic Test: gasdermin d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment the serum level of Gasdermin D level in vitiligo patients
estimate the serum level of Gasdermin D level in vitiligo patients and correlate its level with disease activity and various disease parameters.
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Serum Gasdermin D in VitiligoStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ashraf Sayed Abdelghany, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584643
- Sponsor's protocol ID
- Serum Gasdermin D in vitiligo
- Status last verified
- Nov 2023
- First submitted
- 18 Dec 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergqvist C, Ezzedine K. Vitiligo: A Review. Dermatology. 2020;236(6):571-592. doi: 10.1159/000506103. Epub 2020 Mar 10.
PubMed 32155629Chen J, Li S, Li C. Mechanisms of melanocyte death in vitiligo. Med Res Rev. 2021 Mar;41(2):1138-1166. doi: 10.1002/med.21754. Epub 2020 Nov 17.
PubMed 33200838Shi J, Gao W, Shao F. Pyroptosis: Gasdermin-Mediated Programmed Necrotic Cell Death. Trends Biochem Sci. 2017 Apr;42(4):245-254. doi: 10.1016/j.tibs.2016.10.004. Epub 2016 Dec 5.
PubMed 27932073Broz P, Pelegrin P, Shao F. The gasdermins, a protein family executing cell death and inflammation. Nat Rev Immunol. 2020 Mar;20(3):143-157. doi: 10.1038/s41577-019-0228-2. Epub 2019 Nov 5.
PubMed 31690840Shi J, Zhao Y, Wang K, Shi X, Wang Y, Huang H, Zhuang Y, Cai T, Wang F, Shao F. Cleavage of GSDMD by inflammatory caspases determines pyroptotic cell death. Nature. 2015 Oct 29;526(7575):660-5. doi: 10.1038/nature15514. Epub 2015 Sep 16.
PubMed 26375003Rogers C, Fernandes-Alnemri T, Mayes L, Alnemri D, Cingolani G, Alnemri ES. Cleavage of DFNA5 by caspase-3 during apoptosis mediates progression to secondary necrotic/pyroptotic cell death. Nat Commun. 2017 Jan 3;8:14128. doi: 10.1038/ncomms14128.
PubMed 28045099Zhang D, Li Y, Du C, Sang L, Liu L, Li Y, Wang F, Fan W, Tang P, Zhang S, Chen D, Wang Y, Wang X, Xie X, Jiang Z, Song Y, Guo R. Evidence of pyroptosis and ferroptosis extensively involved in autoimmune diseases at the single-cell transcriptome level. J Transl Med. 2022 Aug 12;20(1):363. doi: 10.1186/s12967-022-03566-6.
PubMed 35962439Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677.
PubMed 15210457Rossiter ND, Chapman P, Haywood IA. How big is a hand? Burns. 1996 May;22(3):230-1. doi: 10.1016/0305-4179(95)00118-2.
PubMed 8726264Kawakami T, Hashimoto T. Disease severity indexes and treatment evaluation criteria in vitiligo. Dermatol Res Pract. 2011;2011:750342. doi: 10.1155/2011/750342. Epub 2011 May 22.
PubMed 21747840Njoo MD, Das PK, Bos JD, Westerhof W. Association of the Kobner phenomenon with disease activity and therapeutic responsiveness in vitiligo vulgaris. Arch Dermatol. 1999 Apr;135(4):407-13. doi: 10.1001/archderm.135.4.407.
PubMed 10206047
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Gasdermin D Level As a Potential Biomarker of Disease Activity in Vitiligo Patients
- ClinicalTrials.gov ID
- NCT06584643
- Acronym / sponsor ID
- Serum Gasdermin D in vitiligo
- Conditions
- Serum Gasdermin D in Vitiligo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Sep 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.
Assessment the serum level of Gasdermin D level in vitiligo patients. Correlate its level with disease activity scores using Vitiligo Area Severity Index (VASI) and Vitiligo Disease Activity (VIDA) scores and with different disease parameters.
Detailed description
Vitiligo, a common depigmenting skin disorder, has an estimated prevalence of 0.5-2% of the population worldwide. The disease is characterized by the selective loss of melanocytes which results in typical nonscaly, chalky-white macules. In recent years, considerable progress has been made in our understanding of the pathogenesis of vitiligo which is now clearly classified as an autoimmune disease .
The destruction of melanocyte is thought to be of multifactorial causation. Genome-wide associated studies have identified single-nucleotide polymorphisms in a panel of susceptible loci as risk factors in melanocyte death. But vitiligo onset can't be solely attributed to a susceptive genetic background .
Oxidative stress triggered by elevated levels of reactive oxygen species accounts for melanocytic molecular and organelle dysfunction, in addition to the self-responsive immune function directly contributes to the bulk of melanocyte deaths in vitiligo .
Moreover, apoptosis is the most extensively documented way of melanocyte demise, with few melanocytes undergo necrosis. But forms of cell death are not merely restricted to apoptosis and necrosis. Cells may die from accidental cell death (ACD) or regulated cell death (RCD). ACD, like necrosis, is biologically uncontrolled, whereas RCD (apoptosis, necroptosis, pyroptosis, oxeiptosis, ferroptosis, parthanatos, etc.) involves precise signaling cascade and molecular mechanisms .
Pyroptosis is mechanistically distinct from other forms of cell death with gasdermin D (GSDMD) and caspase-1/4/5/11 activation as its defining feature . Upon being stimulated by damage-associated molecular patterns molecules (DAMPs), pathogen-associated molecular patterns molecules or altered homeostasis, caspases are activated to cleave the downstream GSDMD. GSDMD fragment with membrane pore-forming activity yields plasma membrane rupture, cytosolic content release, and concurrent cell swelling and lysis
Gasdermins belong to the pore-forming protein family and consist of six gasdermin proteins, including gasdermins A-E. The members of the gasdermin family have two domains: an N-terminal domain and a C-terminal domain linked by a flexible peptide. Upon activation, the cleaved N-terminal domain is responsible for inducing pyroptosis . GSDMD, the most extensively studied executive pyroptosis-executing protein with the clearest mechanism.
In a previous study, scRNA-seq datasets of skin-derived cells from healthy donors and patients with vitiligo were analysed. Results demonstrated that CASP1, CASP4, CASP6, CASP8, and GSDMD expression was significantly upregulated in melanocytes of patients with vitiligo. These results indicated that pyroptosis signaling is an important pathway in the development of vitiligo .
To the best of our knowledge, no previous studies have evaluated the serum level of Gasdermin D as a potential biomarker in vitiligo patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: gasdermin dFor every patient, a full history will be taken recording age, gender, education, residence, special habits, age at onset of vitiligo, duration of vitiligo, stability of vitiligo and family history. A detailed cutaneous examination will be performed including skin phototype, Koebner phenomenon, vitiligo clinical type, leukotrichia, Vitiligo Area Severity Index (VASI) and Vitiligo Disease Activity (VIDA) scores. |
| healthy control | – | Diagnostic Test: gasdermin dage and gender matched healthy volunteers as controls |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For every patient, a full history will be taken recording age, gender, education, residence, special habits, age at onset of vitiligo, duration of vitiligo, stability of vitiligo and family history. A detailed cutaneous examination will be performed including skin phototype, Koebner phenomenon, vitiligo clinical type, leukotrichia, Vitiligo Area Severity Index (VASI) and Vitiligo Disease Activity (VIDA) scores.
Key inclusion criteria (1 listed)
- All clinically diagnosed cases of vitiligo (segmental and non-segmental).
Key exclusion criteria (6 listed)
- patients with inflammatory diseases.
- patients with autoimmne diseases.
- patients with neurodegenerative diseases.
- patients with HIV or COVID19 infection or any other type of infections.
- patients with systemic diseases as liver diseases or having tumors.
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 |
|---|---|---|
| gasdermin devaluation of serum gasdermin d in vitligo patients and healthy controls | Diagnostic test | case group, healthy control |
Primary outcome
Assessment the serum level of Gasdermin D level in vitiligo patients
Time frame: basline
estimate the serum level of Gasdermin D level in vitiligo patients and correlate its level with disease activity and various disease parameters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Background: PubMed 32155629Bergqvist C, Ezzedine K. Vitiligo: A Review. Dermatology. 2020;236(6):571-592. doi: 10.1159/000506103. Epub 2020 Mar 10.
- Background: PubMed 33200838Chen J, Li S, Li C. Mechanisms of melanocyte death in vitiligo. Med Res Rev. 2021 Mar;41(2):1138-1166. doi: 10.1002/med.21754. Epub 2020 Nov 17.
- Background: PubMed 27932073Shi J, Gao W, Shao F. Pyroptosis: Gasdermin-Mediated Programmed Necrotic Cell Death. Trends Biochem Sci. 2017 Apr;42(4):245-254. doi: 10.1016/j.tibs.2016.10.004. Epub 2016 Dec 5.
- Background: PubMed 31690840Broz P, Pelegrin P, Shao F. The gasdermins, a protein family executing cell death and inflammation. Nat Rev Immunol. 2020 Mar;20(3):143-157. doi: 10.1038/s41577-019-0228-2. Epub 2019 Nov 5.
- Background: PubMed 26375003Shi J, Zhao Y, Wang K, Shi X, Wang Y, Huang H, Zhuang Y, Cai T, Wang F, Shao F. Cleavage of GSDMD by inflammatory caspases determines pyroptotic cell death. Nature. 2015 Oct 29;526(7575):660-5. doi: 10.1038/nature15514. Epub 2015 Sep 16.
- Background: PubMed 28045099Rogers C, Fernandes-Alnemri T, Mayes L, Alnemri D, Cingolani G, Alnemri ES. Cleavage of DFNA5 by caspase-3 during apoptosis mediates progression to secondary necrotic/pyroptotic cell death. Nat Commun. 2017 Jan 3;8:14128. doi: 10.1038/ncomms14128.
- Background: PubMed 35962439Zhang D, Li Y, Du C, Sang L, Liu L, Li Y, Wang F, Fan W, Tang P, Zhang S, Chen D, Wang Y, Wang X, Xie X, Jiang Z, Song Y, Guo R. Evidence of pyroptosis and ferroptosis extensively involved in autoimmune diseases at the single-cell transcriptome level. J Transl Med. 2022 Aug 12;20(1):363. doi: 10.1186/s12967-022-03566-6.
- Background: PubMed 15210457Hamzavi I, Jain H, McLean D, Shapiro J, Zeng H, Lui H. Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 2004 Jun;140(6):677-83. doi: 10.1001/archderm.140.6.677.
- Background: PubMed 8726264Rossiter ND, Chapman P, Haywood IA. How big is a hand? Burns. 1996 May;22(3):230-1. doi: 10.1016/0305-4179(95)00118-2.
- Background: PubMed 21747840Kawakami T, Hashimoto T. Disease severity indexes and treatment evaluation criteria in vitiligo. Dermatol Res Pract. 2011;2011:750342. doi: 10.1155/2011/750342. Epub 2011 May 22.
- Background: PubMed 10206047Njoo MD, Das PK, Bos JD, Westerhof W. Association of the Kobner phenomenon with disease activity and therapeutic responsiveness in vitiligo vulgaris. Arch Dermatol. 1999 Apr;135(4):407-13. doi: 10.1001/archderm.135.4.407.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Serum Gasdermin D in Vitiligo, run by Assiut 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 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 5 Sep 2024. 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 Fatma Ashraf Sayed abdelgany, resisdant doctor (0882210622, fy23237@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment the serum level of Gasdermin D level in vitiligo patients (time frame: basline). 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 NCT06584643, which also lists 11 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 5 Sep 2024.