VitiligoNCT05869942
Histochemical Study of Vitiligo in Sohag University Hospital Patients
A study testing Light microscopic studies and Immunohistochemical studies in people with Vitiligo, run by Sohag University at 1 site in Egypt.
Trial summary
Vitiligo is a common acquired idiopathic disorder characterized by depigmentation of the skin, hair, and mucous membranes in the form of macules and patches due to selective melanocyte destruction . Incidence of Vitiligo is about 0.5% to 2% of the world's population, and its incidence continues to increase. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- Light microscopic studies and Immunohistochemical studies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2023to 15 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study will include patients with vitiligo aged 18-50 years old.
Who cannot join
- Pregnancy
- Lactation
- Patient on immunosuppressive treatment for vitiligo over the last month
- Skin diseases, other than vitiligo.
- Systemic diseases particulary endocrine disorders and autoimmune connective tissue diseases.
Trial locations and contacts
1 site in 1 country.
Samira M Mohamed, Lecturer contact
About this study
Official title: Histological and Histochemical Study of Vitiligo Pathogenesis in Sohag University Hospital Patients
Vitiligo is a common acquired idiopathic disorder characterized by depigmentation of the skin, hair, and mucous membranes in the form of macules and patches due to selective melanocyte destruction . Incidence of Vitiligo is about 0.5% to 2% of the world's population, and its incidence continues to increase. Vitiligo can appear at any age group especially in the second and third decades of life. About one-third of vitiligo patients are children under ten years old Vitiligo can be classified into non-segmental, segmental, mixed and unclassifiable/undetermined types. Vitiligo has a negative impact on patient's quality of life by decreasing their self-confidence and causing significant psychological distress.
Read the detailed description
The pathogenesis of vitiligo is still unclear but some theories can explain it such as oxidative stress, autoimmunity, autocytotoxicity, genetic factors, neural and melanocytorrhagy . Loss of pigment which occur in vitiligo may be due to two main causes: absence of melanocytes and/or the inability of melanocytes to produce and store melanin in melanosomes in the process of melanogenesis.
High mobility group box protein B1 (HMGB1) normally presents in the nucleus to maintain genomic stabilization and regulate gene transcription. but, HMGB1 can be released outside the cell due to exposure to stressful factors such as oxidative stress and function as a damage-associated molecular pattern (DAMP) protein leading to strong proinflammatory effects. Recent data showed that HMGB1 is overexpressed in both blood and lesional specimens from vitiligo patients. Moreover, oxidative stress triggers the release of HMGB1 from keratinocytes and melanocytes, indicating that HMGB1 may participate and play a crucial role in the pathological process of vitiligo.
HMGB1 Directly induces Melanocyte apoptosis through stimulation with reactive oxidative stress (ROS) or ultraviolet B (UVB) in vitro which significantly increases the release of HMGB1 from keratinocytes, which inhibits the expression of melanogenesis-related molecules such as microphthalmia- associated transcription factor (MITF), tyrosinase-related proteins and the gp100 protein in a paracrine manner and finally activate caspase-3 to trigger melanocyte apoptosis
- Conditions
- Vitiligo
- Being tested
- Light microscopic studies, Immunohistochemical studies
- Keywords
- vitiligo, autoimmunity, apoptosis, melanocytes
- Medical subject headings
- Vitiligo, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light microscopic studiesDiagnostic test
Under complete sterile precautions, Skin biopsy will be taken from healthy volunteers of the control group via 3 mm disposable punches and two biopsies will be taken from patients with vitiligo, one from vitiligenous lesion and another from normal skin then will be rinsed in physiological saline and fixed in formalin for 24 hours. The preserved tissues will be trimmed for processing, then undergo dehydration with ethyl alcohol, clearing with xylene, infiltration and embedding with paraffin wax. Paraffin wax blocks will be sectioned at 5μ then mounted on glass slides. Sectioned slides will be stained with hematoxylin and eosin and other histological stains and mounted with (DPX). And examined by light microscope. The pathological changes in vitiligenous skin will be detected
Immunohistochemical studiesDiagnostic test
Monoclonal HMGB1 and active caspase 3 antibodies
| Study group | Role | What they receive |
|---|---|---|
| groupA (Diseased group) | Active comparator | patients with Vitiligo Receives: Diagnostic Test: Light microscopic studies; Diagnostic Test: Immunohistochemical studies |
| group B(Control group) | Active comparator | Normal control group not diseased Receives: Diagnostic Test: Light microscopic studies; Diagnostic Test: Immunohistochemical studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of tissue expression of HMGB1 in patients with vitiligo compared to normal control.
Monoclonal HMGB1 antibodie assessment by Skin biopsy from healthy volunteers of the control group via 3 mm disposable punches and two biopsies will be taken from patients with vitiligo, one from vitiligenous lesion and another from normal skin.
Measured: 12 months
Assessment of tissue expression of active caspase 3 in patients with vitiligo compared to normal
active caspase 3 antibodie assessment by Skin biopsy from healthy volunteers of the control group via 3 mm disposable punches and two biopsies will be taken from patients with vitiligo, one from vitiligenous lesion and another from normal skin.
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 posted22 May 2023
- Study start15 Jun 2023 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion15 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
- Model description
- Under complete sterile precautions, Skin biopsy will be taken from healthy volunteers of the control group via 3 mm disposable punches and two biopsies will be taken from patients with vitiligo, one from vitiligenous lesion and another from normal skin then will be rinsed in physiological saline and fixed in formalin for 24 hours. The preserved tissues will be trimmed for processing, then undergo dehydration with ethyl alcohol, clearing with xylene, infiltration and embedding with paraffin wax. Paraffin wax blocks will be sectioned at 5μ then mounted on glass slides. Sectioned slides will be stained with hematoxylin and eosin and other histological stains and mounted with (DPX). And examined by light microscope. The pathological changes in vitiligenous skin will be detected. Monoclonal HMGB1 and active caspase 3 antibodies assessment.
- 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, Noha Mamdouh Ahmed, Sohag University
- Investigators
- Doha S Mohamed, professor, Study chair, Sohag University, Faculty of MedicineZeinab A Goda, lecturer, Study director, Sohag University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869942
- Sponsor's protocol ID
- Soh-Med-23-04-25MS
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bellei B, Picardo M. Premature cell senescence in human skin: Dual face in chronic acquired pigmentary disorders. Ageing Res Rev. 2020 Jan;57:100981. doi: 10.1016/j.arr.2019.100981. Epub 2019 Nov 14.
PubMed 31733332Faraj S, Kemp EH, Gawkrodger DJ. Patho-immunological mechanisms of vitiligo: the role of the innate and adaptive immunities and environmental stress factors. Clin Exp Immunol. 2022 Jan 28;207(1):27-43. doi: 10.1093/cei/uxab002.
PubMed 35020865Wei G, Pan Y, Wang J, Xiong X, He Y, Xu J. Role of HMGB1 in Vitiligo: Current Perceptions and Future Perspectives. Clin Cosmet Investig Dermatol. 2022 Oct 13;15:2177-2186. doi: 10.2147/CCID.S381432. eCollection 2022.
PubMed 36267690Wang J, Pan Y, Wei G, Mao H, Liu R, He Y. Damage-associated molecular patterns in vitiligo: igniter fuse from oxidative stress to melanocyte loss. Redox Rep. 2022 Dec;27(1):193-199. doi: 10.1080/13510002.2022.2123864.
PubMed 36154894
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological and Histochemical Study of Vitiligo Pathogenesis in Sohag University Hospital Patients
- ClinicalTrials.gov ID
- NCT05869942
- Acronym / sponsor ID
- Soh-Med-23-04-25MS
- Conditions
- Vitiligo
- Keywords
- vitiligo, autoimmunity, apoptosis, melanocytes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 22 May 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 a common acquired idiopathic disorder characterized by depigmentation of the skin, hair, and mucous membranes in the form of macules and patches due to selective melanocyte destruction . Incidence of Vitiligo is about 0.5% to 2% of the world's population, and its incidence continues to increase. Vitiligo can appear at any age group especially in the second and third decades of life. About one-third of vitiligo patients are children under ten years old Vitiligo can be classified into non-segmental, segmental, mixed and unclassifiable/undetermined types. Vitiligo has a negative impact on patient's quality of life by decreasing their self-confidence and causing significant psychological distress.
Detailed description
The pathogenesis of vitiligo is still unclear but some theories can explain it such as oxidative stress, autoimmunity, autocytotoxicity, genetic factors, neural and melanocytorrhagy . Loss of pigment which occur in vitiligo may be due to two main causes: absence of melanocytes and/or the inability of melanocytes to produce and store melanin in melanosomes in the process of melanogenesis.
High mobility group box protein B1 (HMGB1) normally presents in the nucleus to maintain genomic stabilization and regulate gene transcription. but, HMGB1 can be released outside the cell due to exposure to stressful factors such as oxidative stress and function as a damage-associated molecular pattern (DAMP) protein leading to strong proinflammatory effects. Recent data showed that HMGB1 is overexpressed in both blood and lesional specimens from vitiligo patients. Moreover, oxidative stress triggers the release of HMGB1 from keratinocytes and melanocytes, indicating that HMGB1 may participate and play a crucial role in the pathological process of vitiligo.
HMGB1 Directly induces Melanocyte apoptosis through stimulation with reactive oxidative stress (ROS) or ultraviolet B (UVB) in vitro which significantly increases the release of HMGB1 from keratinocytes, which inhibits the expression of melanogenesis-related molecules such as microphthalmia- associated transcription factor (MITF), tyrosinase-related proteins and the gp100 protein in a paracrine manner and finally activate caspase-3 to trigger melanocyte apoptosis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Under complete sterile precautions, Skin biopsy will be taken from healthy volunteers of the control group via 3 mm disposable punches and two biopsies will be taken from patients with vitiligo, one from vitiligenous lesion and another from normal skin then will be rinsed in physiological saline and fixed in formalin for 24 hours. The preserved tissues will be trimmed for processing, then undergo dehydration with ethyl alcohol, clearing with xylene, infiltration and embedding with paraffin wax. Paraffin wax blocks will be sectioned at 5μ then mounted on glass slides. Sectioned slides will be stained with hematoxylin and eosin and other histological stains and mounted with (DPX). And examined by light microscope. The pathological changes in vitiligenous skin will be detected. Monoclonal HMGB1 and active caspase 3 antibodies assessment.
| Arm | Type | Receives |
|---|---|---|
| groupA (Diseased group) | Active comparator | Diagnostic Test: Light microscopic studies, Diagnostic Test: Immunohistochemical studiespatients with Vitiligo |
| group B(Control group) | Active comparator | Diagnostic Test: Light microscopic studies, Diagnostic Test: Immunohistochemical studiesNormal control group not diseased |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study will include patients with vitiligo aged 18-50 years old.
Key exclusion criteria (5 listed)
- Pregnancy
- Lactation
- Patient on immunosuppressive treatment for vitiligo over the last month
- Skin diseases, other than vitiligo.
- Systemic diseases particulary endocrine disorders and autoimmune connective tissue 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 |
|---|---|---|
| Light microscopic studiesUnder complete sterile precautions, Skin biopsy will be taken from healthy volunteers of the control group via 3 mm disposable punches and two biopsies will be taken from patients with vitiligo, one from vitiligenous lesion and another from normal skin then will be rinsed in physiological saline and fixed in formalin for 24 hours. The preserved tissues will be trimmed for processing, then undergo dehydration with ethyl alcohol, clearing with xylene, infiltration and embedding with paraffin wax. Paraffin wax blocks will be sectioned at 5μ then mounted on glass slides. Sectioned slides will be stained with hematoxylin and eosin and other histological stains and mounted with (DPX). And examined by light microscope. The pathological changes in vitiligenous skin will be detected | Diagnostic test | group B(Control group), groupA (Diseased group) |
| Immunohistochemical studiesMonoclonal HMGB1 and active caspase 3 antibodies | Diagnostic test | group B(Control group), groupA (Diseased group) |
Primary outcome
Assessment of tissue expression of HMGB1 in patients with vitiligo compared to normal control.
Time frame: 12 months
Monoclonal HMGB1 antibodie assessment by Skin biopsy from healthy volunteers of the control group via 3 mm disposable punches and two biopsies will be taken from patients with vitiligo, one from vitiligenous lesion and another from normal skin.
Assessment of tissue expression of active caspase 3 in patients with vitiligo compared to normal
Time frame: 12 months
active caspase 3 antibodie assessment by Skin biopsy from healthy volunteers of the control group via 3 mm disposable punches and two biopsies will be taken from patients with vitiligo, one from vitiligenous lesion and another from normal skin.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Background: PubMed 31733332Bellei B, Picardo M. Premature cell senescence in human skin: Dual face in chronic acquired pigmentary disorders. Ageing Res Rev. 2020 Jan;57:100981. doi: 10.1016/j.arr.2019.100981. Epub 2019 Nov 14.
- Background: PubMed 35020865Faraj S, Kemp EH, Gawkrodger DJ. Patho-immunological mechanisms of vitiligo: the role of the innate and adaptive immunities and environmental stress factors. Clin Exp Immunol. 2022 Jan 28;207(1):27-43. doi: 10.1093/cei/uxab002.
- Background: PubMed 36267690Wei G, Pan Y, Wang J, Xiong X, He Y, Xu J. Role of HMGB1 in Vitiligo: Current Perceptions and Future Perspectives. Clin Cosmet Investig Dermatol. 2022 Oct 13;15:2177-2186. doi: 10.2147/CCID.S381432. eCollection 2022.
- Background: PubMed 36154894Wang J, Pan Y, Wei G, Mao H, Liu R, He Y. Damage-associated molecular patterns in vitiligo: igniter fuse from oxidative stress to melanocyte loss. Redox Rep. 2022 Dec;27(1):193-199. doi: 10.1080/13510002.2022.2123864.
- Individual participant dataSharing planned: No
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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.
Samira M Mohamed, Lecturer contact
Doha S Mohamed, professor study chair
Sohag University, Faculty of Medicine
Zeinab A Goda, lecturer study director
Sohag University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light microscopic studies and Immunohistochemical studies 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 1 inclusion and 5 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 22 May 2023. 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 Noha M Ahmed, Demonstrator (01141077957, nohamamdouh@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 tissue expression of HMGB1 in patients with vitiligo compared to normal control. (time frame: 12 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 NCT05869942, 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 22 May 2023.