Vitiligo, New Treatment and Serum s100B

NCT06768840 | Recruiting Phase 2

• 1 other identifier: EAOsman
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vitiligo, Generalized

Keywords

vitiligo; jak inhibitor; baricitinib; oral mini pulse; dexamethasone; phototherapy

Outcome Measures

Primary Outcomes (4)

• serum s100B in active generalized vitiligo

  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

  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.

  -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.

  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 Outcomes (2)

• clinical satisfaction of the patients

  after stopping treatment

• side effects of treatment

  from the enrollment and monthly till the stopping of treatment

Study Arms (3)

baricitinib

ACTIVE COMPARATOR

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; Radiation: Narrow Band UVB Treatment

control

NO INTERVENTION

healthy matched controls for them serum s100B will be measured

oral mini pulse

ACTIVE COMPARATOR

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.

Drug: oral mini pulse; Radiation: Narrow Band UVB Treatment

Interventions

Baricitinib DRUG

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

baricitinib

oral mini pulse DRUG

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

oral mini pulse

Narrow Band UVB Treatment RADIATION

narrowband ultraviolet rays B phototherapy two sessions per week

baricitinib; oral mini pulse

Eligibility Criteria

• Age: 10 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Qena university hospital, Qena faculty of medicine

Qina, Egypt

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• EMAN A OSMAN, bachelor

  Qena university hospital, Qena faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman A Osman, bachelor

CONTACT

+20 1127052748; em.ea01127@gmail.com

Hassan mo farid, bachelor

CONTACT

+201040435051; dr.hassanfarid96@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 10, 2025
• Study Start: October 2, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)