VitiligoNCT06261073
Evaluation of Serum and Tissue Cathepsin L in Non-segmental Vitiligo Patients
A study testing blood sample and tissue biopsy in people with Vitiligo, run by Sohag University.
Trial summary
Introduction Vitiligo is an autoimmune disease of the skin that targets pigment producing melanocytes and results in patches of depigmentation that are visible as white spots (Frisoli et al., 2020) Vitiligo is a relatively common acquired pigmentation disorder that can cause significant psychological stress (Leung AKC… 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?
- blood sample and tissue biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 1 Mar 2025
- 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
- Patients with non-segmental vitiligo attending the dermatology outpatient clinics of Sohag University hospital. A group of age and sex- matched healthy participants will be included as a control group.
Who cannot join
- (A) Pregnancy and lactation. (B) Patients on topical and systemic treatment for vitiligo in the last 4weeks prior to enrollment in the study.
- Malignacies. (D) Patients with systemic diseases, diabetes, hypertension and bleeding disorders.
- Patients who are receiving chemotherapy or radio therapy.
Trial locations and contacts
No sites are listed yet.
Amr A Ali, Assistant professor contact
About this study
Introduction Vitiligo is an autoimmune disease of the skin that targets pigment producing melanocytes and results in patches of depigmentation that are visible as white spots (Frisoli et al., 2020) Vitiligo is a relatively common acquired pigmentation disorder that can cause significant psychological stress (Leung AKC et al., 2021). The disease affects both genders equally, it can appear at any age, and the average age of onset is somewhat variable in different geographic (Majumder et al, 1993), with an estimated prevalence of 0.5-2% of the population in both adults and children worldwide (Krüger et al, 2012).
Vitiligo results in white macules and patches on the body. Initial lesions occur most frequently on the hands, forearms, feet, and face, favoring a periocular or perioral distribution (Ahmed jan N et al., 2023). Vitiligo lesions are classified into 2 major categories: segmental vitiligo (SV) and non-segmental vitiligo (NSV) (Relke et al ., 2019). Segmental vitiligo is characterized by its early onset, rapid stabilization, and unilateral distribution (Van Geel et al., 2017). Non-segmental vitiligo comprises of generalized (vitiligo vulgaris), acrofacial, mucosal (multifocal), and universal vitiligo (Kovacevic et al., 2016). Non-segmental vitiligo (NSV) is the most common form of vitiligo (Benzekri et al., 2013). Multiple mechanisms are involved in melanocyte disappearance, namely genetic predisposition, environmental triggers, metabolic abnormalities, impaired renewal, and altered inflammatory and immune responses (Boniface K et al ., 2018).
Read more
The results of some studies indicate a frequent association of vitiligo with autoimmune diseases. A number of studies have established a higher prevalence of autoimmune endocrine diseases in women, as well as in non-segmental vitiligo patients and in cases of family history of vitiligo and/or other autoimmune diseases. In addition, it was shown that the prevalence of endocrine diseases increases with increasing area of depigmentation (Troshina EA et al., 2020). Autoimmunity in vitiligo is driven by the IFN-γ-CXCL10 cytokine signaling pathway. Activated melanocyte-specific CD8+ T cells secrete IFN-γ, which signals through the IFN-γ receptor (IFN-γR) to activate JAK1/2 and STAT1. This induces the production of CXCL9 and CXCL10, which signal through their receptor CXCR3 to recruit more auto-reactive T cells to the epidermis, resulting in widespread melanocyte destruction (Harris JE et al., 2017).
The lysosomal cysteine proteinases of the papain family are involved in lysosomal bulk proteolysis, major histocompatibility complex class II-mediated antigen presentation, pro-hormone processing, and extracellular matrix remodeling.
- Conditions
- Vitiligo
- Being tested
- blood sample and tissue biopsy
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample and tissue biopsyDiagnostic test
Serum level of Cathepsin L: 3 cm of blood will be taken on EDTA tubes from patients and control subjects and will be analyzed by double antibody sandwich enzyme-linked immune-sorbent assay (ELISA) to assess the level of CTSL in blood samples. Tissue expression of Cathepsin L: 5 mm punch biopsies will be taken under local anesthesia from lesions and from the adjacent normal skin of patients (from the lesional and peri-lesional sites). Also, skin biopsy of normal skin will be taken from healthy volunteers. The specimen of skin will be immediately placed in a formalin saline, and then immune-histochemical evaluation will be done to evaluate the CTSL expression in tissue.
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-segmental vitiligo | Active comparator | 30vitiligo patients their age above 18 years attending dermatology outpatient clinics of Sohag University hospital. Receives: Diagnostic Test: blood sample and tissue biopsy |
| healthy volunteers. | Active comparator | .A group of age and sex- matched healthy participants will be included as a control group. Receives: Diagnostic Test: blood sample and tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cathepsin L
3 cm of blood will be taken on EDTA tubes from patients and control subjects : 5 mm punch biopsies will be taken under local anesthesia from lesions and from the adjacent normal skin of patients
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 posted15 Feb 2024
- Study start15 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abdelrahim Abdelaal, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261073
- Sponsor's protocol ID
- Soh-Med-24-01-08MS
- 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
Publications
Ghasemi M, Bajouri A, Shafiiyan S, Aghdami N. Hair Follicle as a Source of Pigment-Producing Cells for Treatment of Vitiligo: An Alternative to Epidermis? Tissue Eng Regen Med. 2020 Dec;17(6):815-827. doi: 10.1007/s13770-020-00284-2. Epub 2020 Oct 9.
PubMed 33034877Kageshita T, Yoshii A, Kimura T, Maruo K, Ono T, Himeno M, Nishimura Y. Biochemical and immunohistochemical analysis of cathepsins B, H, L and D in human melanocytic tumours. Arch Dermatol Res. 1995;287(3-4):266-72. doi: 10.1007/BF01105077.
PubMed 7598531Kawada A, Hara K, Kominami E, Hiruma M, Noguchi H, Ishibashi A. Processing of cathepsins L, B and D in psoriatic epidermis. Arch Dermatol Res. 1997 Jan;289(2):87-93. doi: 10.1007/s004030050160.
PubMed 9049042Kovacevic M, Stanimirovic A, Vucic M, Goren A, Situm M, Lukinovic Skudar V, Lotti T. Mixed vitiligo of Blaschko lines: a newly discovered presentation of vitiligo responsive to combination treatment. Dermatol Ther. 2016 Jul;29(4):240-3. doi: 10.1111/dth.12345. Epub 2016 Mar 11.
PubMed 26970077
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 Serum and Tissue Cathepsin L in Non-segmental Vitiligo Patients
- ClinicalTrials.gov ID
- NCT06261073
- Acronym / sponsor ID
- Soh-Med-24-01-08MS
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (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.
Introduction Vitiligo is an autoimmune disease of the skin that targets pigment producing melanocytes and results in patches of depigmentation that are visible as white spots (Frisoli et al., 2020) Vitiligo is a relatively common acquired pigmentation disorder that can cause significant psychological stress (Leung AKC et al., 2021). The disease affects both genders equally, it can appear at any age, and the average age of onset is somewhat variable in different geographic (Majumder et al, 1993), with an estimated prevalence of 0.5-2% of the population in both adults and children worldwide (Krüger et al, 2012).
Vitiligo results in white macules and patches on the body. Initial lesions occur most frequently on the hands, forearms, feet, and face, favoring a periocular or perioral distribution (Ahmed jan N et al., 2023). Vitiligo lesions are classified into 2 major categories: segmental vitiligo (SV) and non-segmental vitiligo (NSV) (Relke et al ., 2019). Segmental vitiligo is characterized by its early onset, rapid stabilization, and unilateral distribution (Van Geel et al., 2017). Non-segmental vitiligo comprises of generalized (vitiligo vulgaris), acrofacial, mucosal (multifocal), and universal vitiligo (Kovacevic et al., 2016). Non-segmental vitiligo (NSV) is the most common form of vitiligo (Benzekri et al., 2013). Multiple mechanisms are involved in melanocyte disappearance, namely genetic predisposition, environmental triggers, metabolic abnormalities, impaired renewal, and altered inflammatory and immune responses (Boniface K et al ., 2018).
The results of some studies indicate a frequent association of vitiligo with autoimmune diseases. A number of studies have established a higher prevalence of autoimmune endocrine diseases in women, as well as in non-segmental vitiligo patients and in cases of family history of vitiligo and/or other autoimmune diseases. In addition, it was shown that the prevalence of endocrine diseases increases with increasing area of depigmentation (Troshina EA et al., 2020). Autoimmunity in vitiligo is driven by the IFN-γ-CXCL10 cytokine signaling pathway. Activated melanocyte-specific CD8+ T cells secrete IFN-γ, which signals through the IFN-γ receptor (IFN-γR) to activate JAK1/2 and STAT1. This induces the production of CXCL9 and CXCL10, which signal through their receptor CXCR3 to recruit more auto-reactive T cells to the epidermis, resulting in widespread melanocyte destruction (Harris JE et al., 2017).
The lysosomal cysteine proteinases of the papain family are involved in lysosomal bulk proteolysis, major histocompatibility complex class II-mediated antigen presentation, pro-hormone processing, and extracellular matrix remodeling.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with non-segmental vitiligo | Active comparator | Diagnostic Test: blood sample and tissue biopsy30vitiligo patients their age above 18 years attending dermatology outpatient clinics of Sohag University hospital. |
| healthy volunteers. | Active comparator | Diagnostic Test: blood sample and tissue biopsy.A group of age and sex- matched healthy participants will be included as a control group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with non-segmental vitiligo attending the dermatology outpatient clinics of Sohag University hospital. A group of age and sex- matched healthy participants will be included as a control group.
Key exclusion criteria (3 listed)
- (A) Pregnancy and lactation. (B) Patients on topical and systemic treatment for vitiligo in the last 4weeks prior to enrollment in the study.
- Malignacies. (D) Patients with systemic diseases, diabetes, hypertension and bleeding disorders.
- Patients who are receiving chemotherapy or radio therapy.
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 |
|---|---|---|
| blood sample and tissue biopsySerum level of Cathepsin L: 3 cm of blood will be taken on EDTA tubes from patients and control subjects and will be analyzed by double antibody sandwich enzyme-linked immune-sorbent assay (ELISA) to assess the level of CTSL in blood samples. Tissue expression of Cathepsin L: 5 mm punch biopsies will be taken under local anesthesia from lesions and from the adjacent normal skin of patients (from the lesional and peri-lesional sites). Also, skin biopsy of normal skin will be taken from healthy volunteers. The specimen of skin will be immediately placed in a formalin saline, and then immune-histochemical evaluation will be done to evaluate the CTSL expression in tissue. | Diagnostic test | Patients with non-segmental vitiligo, healthy volunteers. |
Primary outcome
Cathepsin L
Time frame: 12 months
3 cm of blood will be taken on EDTA tubes from patients and control subjects : 5 mm punch biopsies will be taken under local anesthesia from lesions and from the adjacent normal skin of patients
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 33034877Ghasemi M, Bajouri A, Shafiiyan S, Aghdami N. Hair Follicle as a Source of Pigment-Producing Cells for Treatment of Vitiligo: An Alternative to Epidermis? Tissue Eng Regen Med. 2020 Dec;17(6):815-827. doi: 10.1007/s13770-020-00284-2. Epub 2020 Oct 9.
- Background: PubMed 7598531Kageshita T, Yoshii A, Kimura T, Maruo K, Ono T, Himeno M, Nishimura Y. Biochemical and immunohistochemical analysis of cathepsins B, H, L and D in human melanocytic tumours. Arch Dermatol Res. 1995;287(3-4):266-72. doi: 10.1007/BF01105077.
- Background: PubMed 9049042Kawada A, Hara K, Kominami E, Hiruma M, Noguchi H, Ishibashi A. Processing of cathepsins L, B and D in psoriatic epidermis. Arch Dermatol Res. 1997 Jan;289(2):87-93. doi: 10.1007/s004030050160.
- Background: PubMed 26970077Kovacevic M, Stanimirovic A, Vucic M, Goren A, Situm M, Lukinovic Skudar V, Lotti T. Mixed vitiligo of Blaschko lines: a newly discovered presentation of vitiligo responsive to combination treatment. Dermatol Ther. 2016 Jul;29(4):240-3. doi: 10.1111/dth.12345. Epub 2016 Mar 11.
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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.
Amr A Ali, Assistant professor contact
Questions about this trial
What is this clinical trial studying?
A study testing blood sample and tissue biopsy 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 3 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 asmaa A abdelaal, Resident (01149620055, asmaa_abdelrehiem_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?
Cathepsin L (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 NCT06261073, 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.