New treatment for generalized vitiligo using JAK inhibitors
Serum s100B in Generalized Vitiligo and Its Relation to Oral Baricitinib, Narrow Band Ultraviolet (B) Therapy
This study is testing if a new medication called baricitinib, combined with light therapy, can help people with active generalized vitiligo regain skin color and improve their quality of life.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 10 Years to 75 Years |
| Sex | All |
| Sponsor | South Valley University Academic / other |
| Drugs / interventions | Baricitinib |
| Locations | 1 site (Qina) |
| Trial ID | NCT06768840 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of baricitinib, a systemic JAK inhibitor, in treating active generalized vitiligo, a skin disorder characterized by depigmented patches. The study aims to assess the treatment's ability to promote repigmentation and improve the quality of life for patients affected by this condition. Participants will receive oral mini pulses of baricitinib along with Narrow Band UVB treatment, while those with specific exclusion criteria will be omitted to ensure accurate evaluation of the treatment's effects. The trial will monitor the safety and effectiveness of this novel approach in a controlled setting.
Who should consider this trial
Good fit: Ideal candidates include individuals with active generalized vitiligo affecting more than 5% of their body surface area, who have not received systemic treatment in the last three months.
Not a fit: Patients with segmental vitiligo, other skin conditions, or those on immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the appearance and quality of life for patients suffering from generalized vitiligo.
How similar studies have performed: While there have been studies on JAK inhibitors for other autoimmune conditions, this specific approach for vitiligo is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Qina
- Qena university hospital, Qena faculty of medicine — Qina, Egypt (Recruiting)
Study contacts
- Principal investigator: EMAN A OSMAN, bachelor — Qena university hospital, Qena faculty of medicine
- Study coordinator: Eman A Osman, bachelor
- Email: em.ea01127@gmail.com
- Phone: +20 1127052748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.