Actively Recruiting

Phase 2
Phase 3
Age: 10Years - 75Years
All Genders
Healthy Volunteers
ID06768840

Serum s100B and Treatment Effects in Generalized Vitiligo Evaluating Oral Baricitinib and Narrowband UVB Phototherapy

Led by South Valley University · Updated on 2025-01-10

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Vitiligo is an autoimmune skin disorder causing white patches on the skin, affecting about 2% of people worldwide. It negatively impacts patients' quality of life and self-esteem. This research studies generalized vitiligo and focuses on evaluating a systemic treatment using a JAK inhibitor called baricitinib, combined with phototherapy, to understand their effects on disease progression and skin re-pigmentation. The study also measures serum s100B levels, a protein linked to melanocyte damage, to explore its relation to vitiligo and treatment response. Participants will receive oral baricitinib—4mg daily for adults and 2mg for children aged 10 to 16 years—or an oral mini pulse of dexamethasone, paired with narrowband ultraviolet B phototherapy twice weekly. The study spans from enrollment to three to six months post-treatment start, monitoring treatment effects on skin re-pigmentation and disease progression. Phototherapy sessions are conducted twice per week throughout the treatment period. During the study, participants will undergo blood tests to measure serum s100B at enrollment and after three months of treatment. Researchers will assess clinical outcomes including stopping vitiligo progression and achieving satisfactory re-pigmentation. Safety and treatment response will be monitored regularly through clinical evaluations. The total participation duration covers at least three months following treatment initiation, with ongoing assessments of skin condition and laboratory markers.

CONDITIONS

Official Title

Vitiligo, New Treatment and Serum s100B

Who Can Participate

Age: 10Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Active generalized vitiligo with more than 5% body surface area affected, excluding hands and feet
  • No systemic vitiligo treatment in the last 3 months
  • No topical vitiligo treatment in the last 4 weeks
  • Age between 10 and 75 years
Not Eligible

You will not qualify if you...

  • Acrofacial, acral, segmental, or mucosal vitiligo
  • Use of other immunosuppressive agents
  • Other skin conditions affecting evaluation such as psoriasis, lupus, or alopecia areata
  • Systemic diseases affecting s100B levels like subarachnoid hemorrhage, Alzheimer disease, or inflammatory diseases
  • Other dermatological diseases affecting s100B like malignant melanoma
  • Immunocompromised status or uncontrolled arterial hypertension
  • Serious infections (viral, bacterial, fungal, parasitic), anemia, or history of thromboembolic events
  • Cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, lymphoproliferative, neurological, neuropsychiatric disorders, or other serious unstable illnesses
  • Pregnancy or lactation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Qena university hospital, Qena faculty of medicine

Qina, Egypt

Actively Recruiting

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Research Team

E

Eman A Osman, bachelor

H

Hassan mo farid, bachelor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Frequently Asked Questions

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