Evaluation Safety ,Efficacy Baricitinib Plus Excimer Light Versus Excimer Light Alone in Non Segmental Vitiligo
Evaluation of Safety and Efficacy of Topical Baricitinib Plus Excimer Light Versus Excimer Light Alone in Treatment in Non-Segmental Vitiligo
1 other identifier
observational
30
0 countries
N/A
Brief Summary
The study aims to evaluate the safety and efficacy of the combination of topical baricitinib and 308-nm monochromatic excimer light versus 308-nm monochromatic excimer light alone in treatment of non-segmental vitiligo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2023
CompletedFirst Posted
Study publicly available on registry
July 18, 2023
CompletedStudy Start
First participant enrolled
September 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedJuly 18, 2023
July 1, 2023
1 year
July 7, 2023
July 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
F VASI score
Face Vitiligo Aera Scoring Index (F-VASI) score will be calculated at baseline, every 4 weeks during the first 12 weeks (duration of treatment) and 3 months after stopping treatment
6 months
Study Arms (2)
Group A
Vitiligo lesions on the face will be treated with cream (Olumiant)2mg twice daily and excimer light308nm DEKA, Florence,Italy twice weekly for 12 weeks.
Group B
Vitiligo lesions on the face will be treated with excimer light308nm (DEKA,F lorence,Italy) only twice weekly for 12 weeks.
Interventions
Eligibility Criteria
cooperation, agreement to join the study , Above 12 years old ,active non segmental vitiligo patients.
You may qualify if:
- Patients of age above 12y old. Patients with active non-segmental vitiligo, having minimum of 1% body surface area (BSA) affected, with significant facial involvement (≥0.5% of the BSA on the face).
- Co-operative patients, agree to join the study and will give consent.
You may not qualify if:
- Patients receiving phototherapy or any form of systemic therapy for vitiligo during the previous 2 months preceding the study.
- Patients applying topical medications to the face during the last month before the study Pregnant or lactating females. Patients with history of allergy to JAK inhibitors, or history of photosensitivity or post inflammatory hyperpigmentation.
- Patients with active skin infection at site of treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Phan K, Phan S, Shumack S, Gupta M. Repigmentation in vitiligo using janus kinase (JAK) inhibitors with phototherapy: systematic review and Meta-analysis. J Dermatolog Treat. 2022 Feb;33(1):173-177. doi: 10.1080/09546634.2020.1735615. Epub 2020 Apr 2.
PMID: 32096671RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yasmin mostafa Tawfik, Doctor
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- General practitioner physician
Study Record Dates
First Submitted
July 7, 2023
First Posted
July 18, 2023
Study Start
September 10, 2023
Primary Completion
September 20, 2024
Study Completion
December 30, 2024
Last Updated
July 18, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share