Comparison Between Apremilast in Combination with NBUVB and NBUVB Alone in Vitiligo - a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To determine the frequency of patients halted their progression and extent of repigmentation
研究概览
简要总结
Patients of non-segmental vitiligo, fulfilling the inclusion criteria will be selected from the OPD, dermatology department. It's an interventional study where Group A patient will be given NBUVB and Tab Apremilast 30 mg twice a day and Group B will receive NBUVB alone.
详细描述
Patients of non-segmental vitiligo, fulfilling the inclusion criteria will be selected from the OPD, dermatology department Dow university hospital. Informed consent will be obtained from all the patients.
Demographic details of patients including age, gender, education, occupation and marital status will be obtained. Further each patient will be asked about duration of vitiligo and any systemic medications used by the patients in the last 6 months will be recorded.
Body Surface Area will be calculated and patients with > 5% of BSA will be included in the study.
Subjects will be randomly divided by lottery method into two groups. Group A patients will be given NBUVB and Tab Apremilast 30 mg twice a day, and Group B patients will receive NBUVB alone.
Hematological baseline including CBC and LFTs will be advised to patients in Group A.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18 years and above
- •Patients of both genders (male and female)
- •Diagnosed patients of non-segmental vitiligo involving > 5% of BSA
排除标准
- •Pregnant and lactating women
- •Concomitant active infection like tuberculosis
- •Personal history of cutaneous malignancy
- •Use of apremilast in the past 4 weeks
- •Use of phototherapy within 4 weeks before randomization
结局指标
主要结局
To determine the frequency of patients halted their progression and extent of repigmentation
时间窗: 32 weeks
Halt in progression and extent of repigmentation from baseline to week 32 in both groups will be calculated by Scale named Vitiligo Area and Severity Index(VASI) done at the baseline and then at week 8, week 16, week 24 and 32. Score of the scale ranges from 0 -100 . Fall in the score will show the improvement.
To determine the frequency of patients showing decrease in the percentage of depigmented areas
时间窗: 32 weeks
This will be performed by calculating Body surface area (BSA ) at the baseline and at week 32 . The patient's palmar surface including their fingers = 1% BSA Scale grading is as follows, mild (less than 3%) moderate (3-10%) severe (greater than 10%) Fall in the percentage of depigmented area is taken as improvement .
次要结局
- DLQI Score and Safety(32 weeks)
研究者
Madiha Sajid
Assistant Professor
Dow University of Health Sciences