Vitiligo, New Treatment and Serum s100B
ConditionVitiligo, Generalized
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age10-75
SponsorSouth Valley University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Baricitinib
Drugoral baricitinib 4mg for adults and 2mg for children 10-16 years for group A
oral mini pulse
Drugpulse dose of oral dexamethasone 2.5mg for adults for two consecutive days per week and half the dose for children
Narrow Band UVB Treatment
Radiationnarrowband ultraviolet rays B phototherapy two sessions per week
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: baricitinibActive comparator 2 interventions
Group B: controlNo intervention 0 interventions
Group C: oral mini pulseActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
at the time of enrollment2
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 .
Time frame
after three months of the start of treatment3
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
Time frame
from the enrollment to three to six months after the start of the treatment4
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
Time frame
from the enrollment to three to six months after the start of the treatmentSecondary outcomes
1
clinical satisfaction of the patients
patient satisfaction will be recorded on a four-point scale as grade 4 highly satisfied grade 1 dissatisfied
Time frame
after stopping treatment2
side effects of treatment
the side effects of treatments e baricitinib, oral mini pulse and phototherapy through regular following up of the patients
Time frame
from the enrollment and monthly till the stopping of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov