Vitiligo, GeneralizedPhase 2/3NCT06768840
Vitiligo, New Treatment and Serum s100B
A Phase 2/3 study testing Baricitinib, oral mini pulse and Narrow Band UVB Treatment in people with Vitiligo, Generalized, run by South Valley University at 1 site in Egypt.
Trial summary
vitiligo is an autoimmune depigmenting skin disorder characterized by milky white macules or patches, with 2% worldwide prevalence. Vitiligo has unexpected course that significantly influences on patient's quality of life and self-esteem. Read more about this study
- Who is it for?
- Ages 10 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo, Generalized
- What is being tested?
- Baricitinib, oral mini pulse and Narrow Band UVB Treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Oct 2024to Oct 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- active generalized vitiligo patients with body surface area involved >5% excluding hands and feet
- no systemic treatment for vitiligo for the last 3 months or topical treatment received for the last 4 weeks.
Who cannot join
- acrofacial, acral, segmental or mucosal vitiligo
- patients on another immunosuppressive agent
- patients have other skin conditions (psoriasis, SLE, alopecia areata) that would interfere with evaluations of the effect of study medication on vitiligo.
- patients who suffered from systemic diseases affecting S100B (e.g. Subarachnoid hemorrhage, Alzheimer disease and inflammatory diseases) or from other dermatological diseases affecting S100B level (e.g. malignant melanoma)
- Patients immunocompromised, uncontrolled arterial hypertension, clinically serious viral, bacterial, fungal, or parasitic infection, anemia, history of thromboembolic event, cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, lymphoproliferative disease, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness.
- Pregnancy and lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Qena university hospital, Qena faculty of medicine
Qina
ali m mohamed, +201001860635, Ali.moussa@svu.edu.eg
About this study
Official title: Serum s100B in Generalized Vitiligo and Its Relation to Oral Baricitinib, Narrow Band Ultraviolet (B) Therapy
vitiligo is an autoimmune depigmenting skin disorder characterized by milky white macules or patches, with 2% worldwide prevalence. Vitiligo has unexpected course that significantly influences on patient's quality of life and self-esteem.
Multiple medications have been introduced for vitiligo treatment, in this study we work on one of systemic JAK inhibitors
Read the detailed description
Vitiligo, an autoimmune depigmenting disorder has a worldwide prevalence of 0.5%-2.0%. distinguished by distinct, varying-shaped depigmented macules and patches. Vitiligo is thought to be a benign condition that mostly affects appearance, although it usually has a significant negative influence on patients' quality of life and self-esteem. It may also put them at higher risk of developing skin cancer and sunburn. 85%-90% of cases are generalized vitiligo, also known as non-segmental vitiligo (NSV), which is characterized by a symmetric body distribution. A number of factors contribute to the multifactorial pathophysiology of vitiligo, including metabolic disorders, oxidative stress, hereditary vulnerability, and autoimmune response. Of these, cell-mediated immunity plays a major role in melanocytes destruction .The interferon-gamma (IFN-γ), C-X-C motif chemokine ligands (CXCL9/10), and C-X-C motif chemokine receptor (CXCR3) signaling axis (IFN-γ-CXCL9/10-CXCR3 or ICC axis) has been identified as a critical mediator for the recruitment of autoimmune CXCR3+ CD8+ T cells. High amounts of INF-γ and tumor necrosis factor alpha (TNF-α) are produced by these cells, which encourage melanocytes (MC) detachment and apoptosis. MCs detachment is prevented by inhibiting IFN-γ signaling pathway, which is regulated by Janus kinase-signal transducer and activator of transcription (JAK-STAT). Treatment goals for vitiligo include arresting, re-pigmentation of existing lesions, and maintenance of re-pigmentation. Only generic immunosuppressants, including oral and topical corticosteroids, calcineurin inhibitors, phototherapy, and surgical procedures, are available as the current traditional therapeutics for vitiligo. One of the primary lines of treatment for generalized vitiligo is narrowband ultraviolet B (NB-UVB) phototherapy, which is always enhanced by combining it with other therapies. JAK inhibitors target the JAK/STAT signaling pathway and are now approved to treat many immune diseases. It was reported that individuals with vitiligo treated with JAK inhibitors had higher rates of re-pigmentation especially when combined with ultraviolet or sun exposure. Given IFN-γ signaling is specially mediated by JAK1 and JAK 2. Baricitinib is a small molecule, which mainly targets the JAK1 and JAK2 subtypes, is already used in dermatology to treat inflammatory dermatoses that are caused by JAK/STAT signaling.
The cytosolic calcium-binding S100 protein family has a variety of intracellular and extracellular activities. A damage-associated molecular pattern protein called S100B has been suggested as a gauge of melanocyte cytotoxicity.
- Conditions
- Vitiligo, Generalized
- Being tested
- Baricitinib, oral mini pulse, Narrow Band UVB Treatment
- Keywords
- vitiligo, jak inhibitor, baricitinib, oral mini pulse, dexamethasone, phototherapy
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
oral baricitinib 4mg for adults and 2mg for children 10-16 years for group A
oral mini pulseDrug
pulse dose of oral dexamethasone 2.5mg for adults for two consecutive days per week and half the dose for children
Narrow Band UVB TreatmentRadiation
narrowband ultraviolet rays B phototherapy two sessions per week
| Study group | Role | What they receive |
|---|---|---|
| baricitinib | Active comparator | group A, vitiligo patients will receive oral baricitinib plus narrow band ultraviolet rays B phototherapy for 3 to 6 months and serum s100B will be measured before the start of the treatment and after three months of the treatment. Receives: Drug: Baricitinib; Radiation: Narrow Band UVB Treatment |
| control | No intervention | healthy matched controls for them serum s100B will be measured |
| oral mini pulse | Active comparator | vitiligo patients will recieve oral mini pulse therapy plus phototherapy for three to six months ,serum s100B will be measured before and three months after start of the treatment. Receives: Drug: oral mini pulse; Radiation: Narrow Band UVB Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum s100B in active generalized vitiligo
detection of the relation of s100B to disease activity in comparison to control group, quantitative assessment of human s100B calcium-binding protein B (pg. /ml) using the available kit
Measured: at the time of enrollment
the effect of treatments on s100B levels
detection the effect of baricitinib ,oral mini-pulse and phototherapy on the serum levels of s100B by measuring the difference of s100B levels before and after three months of treatment .
Measured: after three months of the start of treatment
clinical efficacy of oral baricitinib combined with phototherapy in stopping the progression of the disease.
-the ability of oral baricitinib combined with phototherapy in suppression the activity of the disease in comparison to the conventional treatment (oral mini pulse combined with phototherapy) will be measured using vitiligo diseases activity score (VIDA) in which +4 means highly active and 0 is stable
Measured: from the enrollment to three to six months after the start of the treatment
baricitinib combined with phototherapy in achieving satisfactory re-pigmentation.
the clinical efficacy of baricitinib +NB-UVB in achieving satisfactory re-pigmentation will be measured using vitiligo activity and severity index (VASI) scoring system in which more than or equal 75% represent excellent response and less than 25% is poor response
Measured: from the enrollment to three to six months after the start of the treatment
Secondary outcomes (2)
clinical satisfaction of the patients
patient satisfaction will be recorded on a four-point scale as grade 4 highly satisfied grade 1 dissatisfied
Measured: after stopping treatment
side effects of treatment
the side effects of treatments e baricitinib, oral mini pulse and phototherapy through regular following up of the patients
Measured: from the enrollment and monthly till the stopping of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start2 Oct 2024
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitiligo, GeneralizedStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ahmed Osman, South Valley University
- Investigators
- EMAN A OSMAN, bachelor, Principal investigator, Qena university hospital, Qena faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768840
- Sponsor's protocol ID
- EAOsman
- Status last verified
- Jan 2025
- First submitted
- 26 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum s100B in Generalized Vitiligo and Its Relation to Oral Baricitinib, Narrow Band Ultraviolet (B) Therapy
- ClinicalTrials.gov ID
- NCT06768840
- Acronym / sponsor ID
- EAOsman
- Conditions
- Vitiligo, Generalized
- Keywords
- vitiligo, jak inhibitor, baricitinib, oral mini pulse, dexamethasone, phototherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 10 Jan 2025 (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 autoimmune depigmenting skin disorder characterized by milky white macules or patches, with 2% worldwide prevalence. Vitiligo has unexpected course that significantly influences on patient's quality of life and self-esteem.
Multiple medications have been introduced for vitiligo treatment, in this study we work on one of systemic JAK inhibitors
Detailed description
Vitiligo, an autoimmune depigmenting disorder has a worldwide prevalence of 0.5%-2.0%. distinguished by distinct, varying-shaped depigmented macules and patches. Vitiligo is thought to be a benign condition that mostly affects appearance, although it usually has a significant negative influence on patients' quality of life and self-esteem. It may also put them at higher risk of developing skin cancer and sunburn. 85%-90% of cases are generalized vitiligo, also known as non-segmental vitiligo (NSV), which is characterized by a symmetric body distribution. A number of factors contribute to the multifactorial pathophysiology of vitiligo, including metabolic disorders, oxidative stress, hereditary vulnerability, and autoimmune response. Of these, cell-mediated immunity plays a major role in melanocytes destruction .The interferon-gamma (IFN-γ), C-X-C motif chemokine ligands (CXCL9/10), and C-X-C motif chemokine receptor (CXCR3) signaling axis (IFN-γ-CXCL9/10-CXCR3 or ICC axis) has been identified as a critical mediator for the recruitment of autoimmune CXCR3+ CD8+ T cells. High amounts of INF-γ and tumor necrosis factor alpha (TNF-α) are produced by these cells, which encourage melanocytes (MC) detachment and apoptosis. MCs detachment is prevented by inhibiting IFN-γ signaling pathway, which is regulated by Janus kinase-signal transducer and activator of transcription (JAK-STAT). Treatment goals for vitiligo include arresting, re-pigmentation of existing lesions, and maintenance of re-pigmentation. Only generic immunosuppressants, including oral and topical corticosteroids, calcineurin inhibitors, phototherapy, and surgical procedures, are available as the current traditional therapeutics for vitiligo. One of the primary lines of treatment for generalized vitiligo is narrowband ultraviolet B (NB-UVB) phototherapy, which is always enhanced by combining it with other therapies. JAK inhibitors target the JAK/STAT signaling pathway and are now approved to treat many immune diseases. It was reported that individuals with vitiligo treated with JAK inhibitors had higher rates of re-pigmentation especially when combined with ultraviolet or sun exposure. Given IFN-γ signaling is specially mediated by JAK1 and JAK 2. Baricitinib is a small molecule, which mainly targets the JAK1 and JAK2 subtypes, is already used in dermatology to treat inflammatory dermatoses that are caused by JAK/STAT signaling.
The cytosolic calcium-binding S100 protein family has a variety of intracellular and extracellular activities. A damage-associated molecular pattern protein called S100B has been suggested as a gauge of melanocyte cytotoxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| baricitinib | Active comparator | Drug: Baricitinib, Radiation: Narrow Band UVB Treatmentgroup A, vitiligo patients will receive oral baricitinib plus narrow band ultraviolet rays B phototherapy for 3 to 6 months and serum s100B will be measured before the start of the treatment and after three months of the treatment. |
| control | No intervention | –healthy matched controls for them serum s100B will be measured |
| oral mini pulse | Active comparator | Drug: oral mini pulse, Radiation: Narrow Band UVB Treatmentvitiligo patients will recieve oral mini pulse therapy plus phototherapy for three to six months ,serum s100B will be measured before and three months after start of the treatment. |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- active generalized vitiligo patients with body surface area involved >5% excluding hands and feet
- no systemic treatment for vitiligo for the last 3 months or topical treatment received for the last 4 weeks.
Key exclusion criteria (6 listed)
- acrofacial, acral, segmental or mucosal vitiligo
- patients on another immunosuppressive agent
- patients have other skin conditions (psoriasis, SLE, alopecia areata) that would interfere with evaluations of the effect of study medication on vitiligo.
- patients who suffered from systemic diseases affecting S100B (e.g. Subarachnoid hemorrhage, Alzheimer disease and inflammatory diseases) or from other dermatological diseases affecting S100B level (e.g. malignant melanoma)
- Patients immunocompromised, uncontrolled arterial hypertension, clinically serious viral, bacterial, fungal, or parasitic infection, anemia, history of thromboembolic event, cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, lymphoproliferative disease, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness.
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 |
|---|---|---|
| Baricitiniboral baricitinib 4mg for adults and 2mg for children 10-16 years for group A | Drug | baricitinib |
| oral mini pulsepulse dose of oral dexamethasone 2.5mg for adults for two consecutive days per week and half the dose for children | Drug | oral mini pulse |
| Narrow Band UVB Treatmentnarrowband ultraviolet rays B phototherapy two sessions per week | Radiation | baricitinib, oral mini pulse |
Primary outcome
serum s100B in active generalized vitiligo
Time frame: at the time of enrollment
detection of the relation of s100B to disease activity in comparison to control group, quantitative assessment of human s100B calcium-binding protein B (pg. /ml) using the available kit
the effect of treatments on s100B levels
Time frame: after three months of the start of treatment
detection the effect of baricitinib ,oral mini-pulse and phototherapy on the serum levels of s100B by measuring the difference of s100B levels before and after three months of treatment .
clinical efficacy of oral baricitinib combined with phototherapy in stopping the progression of the disease.
Time frame: from the enrollment to three to six months after the start of the treatment
-the ability of oral baricitinib combined with phototherapy in suppression the activity of the disease in comparison to the conventional treatment (oral mini pulse combined with phototherapy) will be measured using vitiligo diseases activity score (VIDA) in which +4 means highly active and 0 is stable
baricitinib combined with phototherapy in achieving satisfactory re-pigmentation.
Time frame: from the enrollment to three to six months after the start of the treatment
the clinical efficacy of baricitinib +NB-UVB in achieving satisfactory re-pigmentation will be measured using vitiligo activity and severity index (VASI) scoring system in which more than or equal 75% represent excellent response and less than 25% is poor response
2 secondary outcomes
clinical satisfaction of the patients
Time frame: after stopping treatment
side effects of treatment
Time frame: from the enrollment and monthly till the stopping of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- 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.
EMAN A OSMAN, bachelor principal investigator
Qena university hospital, Qena 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 Phase 2/3 study testing Baricitinib, oral mini pulse and Narrow Band UVB Treatment in people with Vitiligo, Generalized, run by South Valley 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 2 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: looking for participants now, as of the sponsor's last update on 10 Jan 2025. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman A Osman, bachelor (+20 1127052748 ext. +20 1070265507, em.ea01127@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum s100B in active generalized vitiligo (time frame: at the time of enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2025.