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NCT06768840
Serum s100B in Generalized Vitiligo and Its Relation to Oral Baricitinib, Narrow Band Ultraviolet (B) Therapy
Phase 2/Phase 3 trial testing Baricitinib in Vitiligo, Generalized in 50 participants. Currently enrolling.
1 August 2025
Quick facts
| Lead sponsor | South Valley University |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 2 October 2024 |
| Primary completion | 1 August 2025 |
| Estimated completion | 1 October 2025 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Baricitinib (baricitinib) — full drug profile →
- oral mini pulse — full drug profile →
- Narrow Band UVB Treatment — full drug profile →
Conditions studied
- Vitiligo, Generalized — all drugs for Vitiligo, Generalized →
Sponsor
South Valley University
Who can join
Adults 10 to 75, any sex, with Vitiligo, Generalized. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
serum s100B in active generalized vitiligo
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06768840
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Other recruiting trials for Vitiligo, Generalized
Currently open trials in the same condition.
- NCT06327321 — Vitiligo Treatment by Targeting TYK2 Mediated Responses · Phase 2 · recruiting
Other South Valley University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06768840 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by South Valley University
- Last refreshed: 6 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06768840.
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