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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus | Active Comparator | Phototherapy NBUVB will be given 3 times per week and Tacrolimus 0.1% ointment will be applied twice a day |
|
| calcipotriol / betamethasone | Active Comparator | Phototherapy NBUVB will be given 3 times per week and calcipotriol & betamethasone containing cream will be applied once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly | Combination Product | Tacrolimus ointment plus phototherapy NBUVB (Tacrolimus arm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| efficacy of treatment | 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 . | Baseline: measurement of vitiligo BSA with photographs of vitiligo areas. lab investigations done at this stage |
| Efficacy of 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. | 3 months post treatment |
| Efficacy of treatment | The area of vitiligo will be measured using body surface area (BSA). 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. | 6 months post treatment |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diala Alshiyab, MD | Jordan University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diala Alshiyab | Irbid | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37644869 | Derived | Alshiyab D, Al-Qarqaz F, Ba-Shammakh S, Al-Fakih A, Altawalbeh A, Alsheyab S, Sarakbi D, Muhaidat J. Comparison of the efficacy of tacrolimus 0.1% ointment vs calcipotriol/betamethasone in combination with NBUVB in treatment of vitiligo. J Dermatolog Treat. 2023 Dec;34(1):2252119. doi: 10.1080/09546634.2023.2252119. |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| C055085 | calcipotriene |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Calcipotriol/Betamethasone ointment plus NBUVB | Combination Product | Calcipotriol/Betamethasone ointment once daily plus NBUVB 3 times weekly |
|