Comparison of the Efficacy of Tacrolimus 0.1% Ointment vs Calcipotriol/Betamethasone in Combination With NBUVB in Treatment of Vitiligo
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- efficacy of treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Tacrolimus
Phototherapy NBUVB will be given 3 times per week and Tacrolimus 0.1% ointment will be applied twice a day
干预措施: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly (Combination Product)
Tacrolimus
Phototherapy NBUVB will be given 3 times per week and Tacrolimus 0.1% ointment will be applied twice a day
干预措施: Calcipotriol/Betamethasone ointment plus NBUVB (Combination Product)
calcipotriol / betamethasone
Phototherapy NBUVB will be given 3 times per week and calcipotriol & betamethasone containing cream will be applied once a day
干预措施: Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly (Combination Product)
calcipotriol / betamethasone
Phototherapy NBUVB will be given 3 times per week and calcipotriol & betamethasone containing cream will be applied once a day
干预措施: Calcipotriol/Betamethasone ointment plus NBUVB (Combination Product)
结局指标
主要结局
efficacy of treatment
时间窗: 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
时间窗: 6 months post 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.
Efficacy of treatment
时间窗: 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.
次要结局
未报告次要终点