VitiligoNCT06261086
Evaluation of Pyroptosis-related Indicators in the Pathogenesis of Vitiligo:Across-sectional Comparative Study
A study testing evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18) in people with Vitiligo, run by Sohag University.
Trial summary
Vitiligo is an acquired pigmentary disorder on skin and/or mucosae, which is characterized by death of melanocytes (MCs), affecting 0.5%-2% of the population worldwide (1). It doesn't affect the health of patients but it has marked social pressure and greatly interfere with their quality of life (2,3). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2024to 24 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
- Patients with vitiligo ≥ 18 years old, both male and female patients will be included.
Who cannot join
- Patients with the following criteria will be excluded from our study:
- Pregnancy and breast-feeding women
- patients on antioxidants or anti-inflammatory drugs
- Patients on topical/systemic treatment for vitiligo in the last 4weeks prior to enrollment in the study
- Patients with other dermatological diseases as psoriasis, lichen planus, viral infection, etc.
- Patients suffering from chronic medical illness such as; diabetes mellitus, thyroid disease, and cancer.
Trial locations and contacts
No sites are listed yet.
essam eldin A nada, professor contact
About this study
Vitiligo is an acquired pigmentary disorder on skin and/or mucosae, which is characterized by death of melanocytes (MCs), affecting 0.5%-2% of the population worldwide (1). It doesn't affect the health of patients but it has marked social pressure and greatly interfere with their quality of life (2,3). It presents with well circumscribed milky white patches that occur secondary to destruction of melanocyte, it may appear at any age and affect both sexes equally.
It can affect ethnic groups and people of all skin types with no predilection (4).
Clinically, several types of vitiligo are distinguished according to the distribution of the achromic lesions. One or more lesions in a dermatomal pattern are characteristic for segmental vitiligo (SV) while this segmental distribution is absent in non-segmental vitiligo (NSV). The latter variety includes both the focal type and the generalized type (5). Numerous previous studies tried to illustrate the pathogenesis behind the disease, but the exact pathophysiology is still not fully understood. It is a multifactorial disease. Factors include, neural theory, oxidative stress theory, autoimmune hypothesis, intrinsic theory, melanocytorrhagy hypothesis (6). Many theories tried to explain the mechanisms of MC destruction in vitiligo. Apoptosis is one of the most widely studied cell death pathways. In addition, the other two forms of cell death, conventional necrosis and autophagy seem to be involved in the death of vitiligo MCs under certain situations. Moreover, new types of regulated cell death including necroptosis, pyroptosis, and ferroptosis may also participate in the pathogenesis (7). Pyroptosis is a highly inflammatory form of necrosis cell death NCD regulated mainly by caspase-1, which is initiated following large supramolecular complex ermed inflammasome activation (8). The inflammasome-activated Caspases then cleave the pyroptosis-inducing protein Gasdermin D (GSDMD), which forms a pore in the plasma membrane and causes cell lysis as well as the secretion of IL-1β typically (9). Another study suggests that inflammasome activation could be a useful marker for assessing disease progression of vitiligo (10). However, the link between vitiligo and inflammasome activation is still unclear. The inflammasome regulates cell death and inflammation via activation of caspase-1 (11). The activation of caspase-1 promotes the secretion of proinflammatory cytokines IL-1β and IL-18, as well as the initiation of pyroptosis (12). So, evaluation of pyroptosis-related indicators (GASDM-D, IL 1β \& IL-18) may help understanding the obscure inflammasome pathway involvement in the pathogenesis of Vitiligo.
- Conditions
- Vitiligo
- Being tested
- evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18)
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18)Diagnostic test
2 ml blood will be collected from all participants (patients and controls) by aseptic venipuncture into plain tubes. Then the samples will be allowed to coagulate during 10-20 minutes. Serum will be obtained by centrifugation at speed of 2000-3000 cycle/min for 20 minutes. Then we collect the supernatant which immediately be frozen at -80°C until analyzed to determine serum levels of pyroptosis-related indicators (GASDM-D, IL 1β \& IL-18). Serum concentration will be assessed by a commercially available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit
| Study group | Role | What they receive |
|---|---|---|
| patient with vitiligo group | Active comparator | Patients with vitiligo ≥ 18 years old, both male and female patients will be included.
Exclusion criteria:
Patients with the following criteria will be excluded from our study:
1. Pregnancy and breast-feeding women.
2. patients on antioxidants or anti-inflammatory drugs
3. Patients on topical/systemic treatment for vitiligo in the last 4weeks prior to enrollment in the study
4. Patients with other dermatological diseases as psoriasis, lichen planus, viral infection, etc.
5. Patients suffering from chronic medical illness such as; diabetes mellitus, thyroid disease, and cancer. Receives: Diagnostic Test: evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18) |
| control group | Active comparator | control criteria with the following criteria will be excluded from our study:
1- Pregnancy and breast-feeding women. Receives: Diagnostic Test: evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GASDM-D
Evaluartion of serum level of (GASDM-D) in patients with Vitiligo as well as in control health group. 2- To correlate level of GASDM-D with severity of the disease.
Measured: 6 months
IL 1β
Evaluation of serum level of IL 1β in patients with Vitiligo as well as in control health group 2- To correlate level of IL 1β with severity of the disease.
Measured: 6 months
IL-18
Evaluation of serum level of IL-18 in patients with Vitiligo as well as in control health group 2- To correlate level of IL-18 with severity of the disease.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start24 Feb 2024 (estimated)
- Primary completion24 Aug 2024 (estimated)
- Study completion24 Aug 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Abdelmawla Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261086
- Sponsor's protocol ID
- soh-med-24-01-06MS
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kruger C, Schallreuter KU. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. Int J Dermatol. 2012 Oct;51(10):1206-12. doi: 10.1111/j.1365-4632.2011.05377.x. Epub 2012 Mar 27.
PubMed 22458952Salman A, Kurt E, Topcuoglu V, Demircay Z. Social Anxiety and Quality of Life in Vitiligo and Acne Patients with Facial Involvement: A Cross-Sectional Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):305-11. doi: 10.1007/s40257-016-0172-x.
PubMed 26818062Osinubi O, Grainge MJ, Hong L, Ahmed A, Batchelor JM, Grindlay D, Thompson AR, Ratib S. The prevalence of psychological comorbidity in people with vitiligo: a systematic review and meta-analysis. Br J Dermatol. 2018 Apr;178(4):863-878. doi: 10.1111/bjd.16049. Epub 2018 Feb 7.
PubMed 28991357Alikhan 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 21839315
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pyroptosis-related Indicators in the Pathogenesis of Vitiligo:Across-sectional Comparative Study
- ClinicalTrials.gov ID
- NCT06261086
- Acronym / sponsor ID
- soh-med-24-01-06MS
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 24 Feb 2024 (estimated)
- Primary completion
- 24 Aug 2024 (estimated)
- Study completion
- 24 Aug 2024 (estimated)
- First posted
- 15 Feb 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.
Vitiligo is an acquired pigmentary disorder on skin and/or mucosae, which is characterized by death of melanocytes (MCs), affecting 0.5%-2% of the population worldwide (1). It doesn't affect the health of patients but it has marked social pressure and greatly interfere with their quality of life (2,3). It presents with well circumscribed milky white patches that occur secondary to destruction of melanocyte, it may appear at any age and affect both sexes equally.
It can affect ethnic groups and people of all skin types with no predilection (4).
Clinically, several types of vitiligo are distinguished according to the distribution of the achromic lesions. One or more lesions in a dermatomal pattern are characteristic for segmental vitiligo (SV) while this segmental distribution is absent in non-segmental vitiligo (NSV). The latter variety includes both the focal type and the generalized type (5). Numerous previous studies tried to illustrate the pathogenesis behind the disease, but the exact pathophysiology is still not fully understood. It is a multifactorial disease. Factors include, neural theory, oxidative stress theory, autoimmune hypothesis, intrinsic theory, melanocytorrhagy hypothesis (6). Many theories tried to explain the mechanisms of MC destruction in vitiligo. Apoptosis is one of the most widely studied cell death pathways. In addition, the other two forms of cell death, conventional necrosis and autophagy seem to be involved in the death of vitiligo MCs under certain situations. Moreover, new types of regulated cell death including necroptosis, pyroptosis, and ferroptosis may also participate in the pathogenesis (7). Pyroptosis is a highly inflammatory form of necrosis cell death NCD regulated mainly by caspase-1, which is initiated following large supramolecular complex ermed inflammasome activation (8). The inflammasome-activated Caspases then cleave the pyroptosis-inducing protein Gasdermin D (GSDMD), which forms a pore in the plasma membrane and causes cell lysis as well as the secretion of IL-1β typically (9). Another study suggests that inflammasome activation could be a useful marker for assessing disease progression of vitiligo (10). However, the link between vitiligo and inflammasome activation is still unclear. The inflammasome regulates cell death and inflammation via activation of caspase-1 (11). The activation of caspase-1 promotes the secretion of proinflammatory cytokines IL-1β and IL-18, as well as the initiation of pyroptosis (12). So, evaluation of pyroptosis-related indicators (GASDM-D, IL 1β \& IL-18) may help understanding the obscure inflammasome pathway involvement in the pathogenesis of Vitiligo.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with vitiligo group | Active comparator | Diagnostic Test: evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18)Patients with vitiligo ≥ 18 years old, both male and female patients will be included. Exclusion criteria: Patients with the following criteria will be excluded from our study: 1. Pregnancy and breast-feeding women. 2. patients on antioxidants or anti-inflammatory drugs 3. Patients on topical/systemic treatment for vitiligo in the last 4weeks prior to enrollment in the study 4. Patients with other dermatological diseases as psoriasis, lichen planus, viral infection, etc. 5. Patients suffering from chronic medical illness such as; diabetes mellitus, thyroid disease, and cancer. |
| control group | Active comparator | Diagnostic Test: evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18)control criteria with the following criteria will be excluded from our study: 1- Pregnancy and breast-feeding women. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with vitiligo ≥ 18 years old, both male and female patients will be included.
Key exclusion criteria (6 listed)
- Patients with the following criteria will be excluded from our study:
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 |
|---|---|---|
| evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18)2 ml blood will be collected from all participants (patients and controls) by aseptic venipuncture into plain tubes. Then the samples will be allowed to coagulate during 10-20 minutes. Serum will be obtained by centrifugation at speed of 2000-3000 cycle/min for 20 minutes. Then we collect the supernatant which immediately be frozen at -80°C until analyzed to determine serum levels of pyroptosis-related indicators (GASDM-D, IL 1β \& IL-18). Serum concentration will be assessed by a commercially available double antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit | Diagnostic test | control group, patient with vitiligo group |
Primary outcome
GASDM-D
Time frame: 6 months
Evaluartion of serum level of (GASDM-D) in patients with Vitiligo as well as in control health group. 2- To correlate level of GASDM-D with severity of the disease.
IL 1β
Time frame: 6 months
Evaluation of serum level of IL 1β in patients with Vitiligo as well as in control health group 2- To correlate level of IL 1β with severity of the disease.
IL-18
Time frame: 6 months
Evaluation of serum level of IL-18 in patients with Vitiligo as well as in control health group 2- To correlate level of IL-18 with severity of the disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 22458952Kruger C, Schallreuter KU. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. Int J Dermatol. 2012 Oct;51(10):1206-12. doi: 10.1111/j.1365-4632.2011.05377.x. Epub 2012 Mar 27.
- Background: PubMed 26818062Salman A, Kurt E, Topcuoglu V, Demircay Z. Social Anxiety and Quality of Life in Vitiligo and Acne Patients with Facial Involvement: A Cross-Sectional Controlled Study. Am J Clin Dermatol. 2016 Jun;17(3):305-11. doi: 10.1007/s40257-016-0172-x.
- Background: PubMed 28991357Osinubi O, Grainge MJ, Hong L, Ahmed A, Batchelor JM, Grindlay D, Thompson AR, Ratib S. The prevalence of psychological comorbidity in people with vitiligo: a systematic review and meta-analysis. Br J Dermatol. 2018 Apr;178(4):863-878. doi: 10.1111/bjd.16049. Epub 2018 Feb 7.
- 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.
- Individual participant dataSharing planned: Undecided
Related trials for Vitiligo
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo
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.
essam eldin A nada, professor contact
Questions about this trial
What is this clinical trial studying?
A study testing evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18) in people with 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 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 15 Feb 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 marwa A Mohammed, resident (01009160620, marwa.mohamed5@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GASDM-D (time frame: 6 months). The study lists 3 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 NCT06261086, 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 15 Feb 2024.