Vitiligo, New Treatment and Serum s100B

January 6, 2025 updated by: Eman Ahmed Osman, South Valley University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eman A Osman, bachelor
  • Phone Number: +20 1070265507 +20 1127052748
  • Email: em.ea01127@gmail.com

Study Contact Backup

Study Locations

  • Egypt
      • Qinā, Egypt
        • Recruiting
        • Qena university hospital, Qena faculty of medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Baricitinib
oral baricitinib 4mg for adults and 2mg for children 10-16 years for group A
Radiation: Narrow Band UVB Treatment
narrowband ultraviolet rays B phototherapy two sessions per week
No Intervention: control
healthy matched controls for them serum s100B will be measured
Active Comparator: 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.
Radiation: Narrow Band UVB Treatment
narrowband ultraviolet rays B phototherapy two sessions per week
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the time of enrollment
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 .
after three months of the start 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
from the enrollment to three to six months after the start of the treatment
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
from the enrollment to three to six months after the start of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical satisfaction of the patients
Time Frame: after stopping treatment
patient satisfaction will be recorded on a four-point scale as grade 4 highly satisfied grade 1 dissatisfied
after stopping treatment
side effects of treatment
Time Frame: from the enrollment and monthly till the stopping of treatment
the side effects of treatments e baricitinib, oral mini pulse and phototherapy through regular following up of the patients
from the enrollment and monthly till the stopping of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Valley University

Investigators

  • Principal Investigator: EMAN A OSMAN, bachelor, Qena university hospital, Qena faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

December 26, 2024

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAOsman

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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