The Efficacy and Safety of Oral Mini-pulse Dexamethasone in Active Non-segmental Vitiligo Within the Pediatric Age Group
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The effect of drug on linear growth
研究概览
简要总结
The goal of this clinical trial is to learn if oral mini pulse (OMP) dexamethasone works to treat active vitiligo in children and also learn about the safety of this drug within this age group the main questions it aims to answer are does OMP halt activity in active vitiligo and what medical problems patients might experience while using the drug with special attention to linear growth. Researchers will give OMP dexamethasone to participating patients to see if the drug works to treat active vitiligo and whether it has any effect on linear growth. Participants will take OMP dexamethasone two fixed days per week for a period of 3 months. before starting treatment, patients will do baseline evaluation and investigations then monthly evaluation to monitor progress, report any side effects at the end of treatment period response to drug, lab values and growth will be evaluated then final evaluation of growth will be done after stoppage of drug.
详细描述
Background: Vitiligo is an autoimmune depigmenting skin disorder. Childhood Vitiligo (CV), defined as Vitiligo that begins before the age of 12 years, is common and may differ from post CV in terms of epidemiology, clinical picture, comorbidities and treatment options. Oral mini pulse (OMP) corticosteroids have been used successfully in both adults and children with active vitiligo. Pulsed regimens allow the achievement of the therapeutic outcome as well as better patient compliance while minimizing the adverse effects of daily steroids, However, its specific impact on linear growth in the pediatric population requires further evaluation. The aim of the current study is to evaluate the efficacy and safety of OMP dexamethasone in pediatric patients with active non-segmental vitiligo with special focus on linear growth.
Methodology: Male and female patients with active vitiligo defined as patients with Vitiligo disease activity score (VIDA) +3 and +4 patients with non-segmental vitiligo between 4-9 yrs will be included in the study. Baseline evaluation will include Vitiligo signs of activity score (VSAS) and Vitiligo area scoring index (VASI) scores, Routine lab investigations, HBA1c, cortisol am, ACTH am, blood pressure. Weight and height will be measured and plotted on WHO z score growth charts. Plain Xray of left hand and wrist for bone age will also be done. Patients will receive OMP dexamethasone in a dose of 0.1 mg/kg/day two consecutive days per week for 3 months. Topical treatment including topical betamethasone cream for body lesions and tacrolimus 0.1% cream for face lesions as well as puva sol /excimer laser will be allowed during the study. Patients will be monitored monthly to evaluate response and side effects. At the end of treatment period (3 months) the following parameters will be evaluated VSAS and VASI scores, weight and height plotted on WHO z scores growth charts. lab investigations including HBA1c, cortisol am and ACTH will be done one week after stoppage of treatment. 3 months after stoppage of treatment patients will be monitored for recurrence, weight and height will be measured and plotted on WHO z scores growth charts and bone age will be evaluated by plain Xray on left hand and wrist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active (VIDA +3 & +4) non segmental vitiligo
- •Age between 4-9yrs
- •Males and Females
- •Children with height measurements within the percentile range 5-95% of normal values for their age.
排除标准
- •Segmental vitiligo.
- •Stable vitiligo.
- •History of endocrine disorders (growth hormone deficiency, thyroid disorders)
- •Growth disorders (Turner's syndrome, Klinefelter's syndrome)
- •Systemic diseases likely to affect growth (IBD, chronic renal failure)
研究组 & 干预措施
OMP dexamethasone 2 consecutive days per week in a dose of 0.1mg/kg/day for 3 months
干预措施: Dexamethasone (0.1 mg/kg) (Drug)
结局指标
主要结局
The effect of drug on linear growth
时间窗: 6 months
The height of patients will be measured at baseline, at the end of treatment period and 3 months after stoppage of treatment. Height measurements will be done using a stadiometer and carefully read to the nearest 0.1 cm then height will be plotted on the WHO z-score growth charts.
The effect of drug on weight gain
时间窗: 6 months
Weight will be measured at baseline, at the end of treatment period and 3 months after stoppage of the drug. Weight will be measured using a digital scale and will be recorded to the nearest 0.1kg then measurements will be plotted on WHO z score growth charts.
The efficacy of dexamethasone in pediatric active non segmental vitiligo
时间窗: 3 months
Vitiligo signs of activity score (VSAS) will be evaluated and compared to baseline values. This scoring system ranges between (0-15). Zero means complete absence of clinical signs of activity. A decrease in the score at the end of the study compared to baseline values is considered an improvement (better outcome).
The effect of drug on bone age
时间窗: 6 months
Plain Xray left hand and wrist will be done 3 months after stoppage of drug and compared to baseline Xray.
次要结局
- The effect of drug on HBA1C(3 months)
- The incidence of adrenal suppression(3 months)
- Incidence of patient reported corticosteroid side effects(3 months)
研究者
Nanis Aleem Abdul Moneim Ragab
Associate professor Dermatology department Cairo University
Cairo University