Vitiligo, New Treatment and Serum s100B

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-02

Study Completion Date

2025-10-31

Brief Summary

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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

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Detailed Description

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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

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Vitiligo, Generalized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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baricitinib

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.

Group Type ACTIVE_COMPARATOR

Baricitinib

Intervention Type DRUG

oral baricitinib 4mg for adults and 2mg for children 10-16 years for group A

Narrow Band UVB Treatment

Intervention Type RADIATION

narrowband ultraviolet rays B phototherapy two sessions per week

control

healthy matched controls for them serum s100B will be measured

Group Type NO_INTERVENTION

No interventions assigned to this group

oral mini pulse

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.

Group Type ACTIVE_COMPARATOR

oral mini pulse

Intervention Type DRUG

pulse dose of oral dexamethasone 2.5mg for adults for two consecutive days per week and half the dose for children

Narrow Band UVB Treatment

Intervention Type RADIATION

narrowband ultraviolet rays B phototherapy two sessions per week

Interventions

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Baricitinib

oral baricitinib 4mg for adults and 2mg for children 10-16 years for group A

Intervention Type DRUG

oral mini pulse

pulse dose of oral dexamethasone 2.5mg for adults for two consecutive days per week and half the dose for children

Intervention Type DRUG

Narrow Band UVB Treatment

narrowband ultraviolet rays B phototherapy two sessions per week

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes