RecruitingPhase 2Phase 3NCT06768840

Vitiligo, New Treatment and Serum s100B

Serum s100B in Generalized Vitiligo and Its Relation to Oral Baricitinib, Narrow Band Ultraviolet (B) Therapy


Sponsor

South Valley University

Enrollment

50 participants

Start Date

Oct 2, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 10 YearsMax Age: 75 Years

Inclusion Criteria2

  • 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 Criteria6

  • 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.

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Interventions

DRUGBaricitinib

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

DRUGoral mini pulse

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

RADIATIONNarrow Band UVB Treatment

narrowband ultraviolet rays B phototherapy two sessions per week


Locations(1)

Qena university hospital, Qena faculty of medicine

Qina, Egypt

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NCT06768840


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