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Recruiting Phase 2/3

Vitiligo, New Treatment and Serum s100B

NCT06768840 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 2/3
Started
2024-10-02
Last updated
2025-01-10

Condition(s) studied

Vitiligo, Generalized

Investigational drug(s) / intervention(s)

Baricitinib →oral mini pulse →Narrow Band UVB Treatment

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

oral mini pulse: 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: narrowband ultraviolet rays B phototherapy two sessions per week

Study 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.

Multiple medications have been introduced for vitiligo treatment, in this study we work on one of systemic JAK inhibitors

Eligibility

Sex
ALL
Min age
10 Years
Max age
75 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • serum s100B in active generalized vitiligo — 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 — 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. — 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. — 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

Trial sites (1)

FacilityCityRegionStatus
Qena university hospital, Qena faculty of medicine Qina Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06768840 on ClinicalTrials.gov ↗ ← All trials in Egypt