Vitiligo, Generalized
Conditions
Brief summary
Patients will be included in a randomized controlled clinical trial, will enroll only adult vitiligo patients with surface area of at least 10% who are being followed in the outpatient dermatology clinics of King Abdullah University Hospital (KAUH) and are planned to start on phototherapy Narrow Band Ultraviolet light B (NBUVB), regardless if they have previous treatment for their disease, one month wash off period will be given for patients who are already on phototherapy or other treatments for vitiligo.
Detailed description
Patients to be included in this randomized controlled study are adults with generalized vitiligo of surface area of at least 10% who are being followed in the outpatient dermatology clinics of King Abdullah University Hospital (KAUH) and are planned to start on phototherapy Narrow Band Ultraviolet light B (NB-UVB), regardless if they have previous treatment for their disease, one month wash off period will be given for patients who are already on phototherapy or other treatments for vitiligo. In our going study, adult patients will be enrolled into 2 groups ( around 20 patients per each) in which NBUVB will be given 2-3 sessions per week in combination with one of the following randomly; one group will start on Tacrolimus 0.1% ointment twice daily, a second group will start on calcipotriol & betamethasone containing cream once daily, photos will be taken and the exact sites involved will be detected, efficacy of treatment will be assessed according to repigmentation percentages of vitiligo areas from baseline at 3 and 6 months. The improvement at 6 months compared to baseline will be classified into 5 groups according to the percentage of repigmentation as follow; excellent (76%-100%); moderate (51%-75%); mild (26%-50%); minimal (1%-25%); or no response.
Interventions
COMBINATION_PRODUCTTacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly
Tacrolimus ointment plus phototherapy NBUVB (Tacrolimus arm)
COMBINATION_PRODUCTCalcipotriol/Betamethasone ointment plus NBUVB
Calcipotriol/Betamethasone ointment once daily plus NBUVB 3 times weekly
Sponsors
Jordan University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients ( ≥ 18 years). * Diagnosed with vitiligo clinically and by using wood's light * Generalized type vitiligo and BSA ≥ 10% * Planned by his physician to start on phototherapy * Wash off period for patients on treatment of one month duration.
Exclusion criteria
* Children less than 18 year old * Localized type vitiligo or BSA less than 10% * Unable to do phototherapy * Pregnant women with vitiligo * Previously failed to response to phototherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy of treatment | Baseline: measurement of vitiligo BSA with photographs of vitiligo areas. lab investigations done at this stage | The area of vitiligo will be measured using body surface area (BSA) at baseline. the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken . |
| Efficacy of treatment | 3 months post treatment | The area of vitiligo will be measured using body surface area (BSA) at 3 months. the difference in BSA will represent the improvement from baseline. Patient palm will be used for estimation of BSA at each visit (Each one plam is equivalent to 1% of BSA). Photographs will be taken. |
Countries
Jordan
Outcome results
None listed