Efficacy of 2% tofacitinib ointment against 0.1% tacrolimus ointment in localized pediatric vitiligo- A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean area repigmentation in group A tofacitinib ointment and group B tacrolimus ointment at 16 weeks from baseline.
研究概览
简要总结
This randomized controlled trial aims to compare the efficacy and safety of 2% tofacitinib ointment with 0.1% tacrolimus ointment in children aged 6–18 years with localized vitiligo. Eligible patients, after informed consent, will be randomized into two groups: Group A will apply 2% tofacitinib ointment twice daily for 16 weeks, and Group B will apply 0.1% tacrolimus ointment twice daily for the same duration. Lesion size will be measured at baseline and at 4-weekly intervals using a transparent sheet and graph paper method, with repigmentation graded on a 0–4 scale. Serial standardized photographs and quality of life assessment using the CDLQI (for ages 10–18 years) will provide additional evaluation. Patients will be monitored for cutaneous side effects such as burning, itching, irritation, or folliculitis, and treatment will be reassessed if significant adverse events occur. The primary outcome will be the mean percentage area of repigmentation at 16 weeks, while secondary outcomes include frequency of side effects, presence of systemic comorbidities, and improvement in quality of life. Final assessment will be done at 16 weeks, and data will be analyzed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with active localized vitiligo.
- •Body surface area of lesions less than 10 precent.
排除标准
- •acrofacial, mucosal, genital, vitiligo universalis.
- •History of any topical or systemic medication in last three months.
- •Child with rapidly progressing vitiligo which requires systemic treatment within 12 weeks of initiating topical therapy.
结局指标
主要结局
Mean area repigmentation in group A tofacitinib ointment and group B tacrolimus ointment at 16 weeks from baseline.
时间窗: Mean area repigmentation in group A tofacitinib ointment and group B tacrolimus ointment at 16 weeks from baseline.
次要结局
- proportion of patients experiencing cutaneous side effects in both groups(baseline, 4 weeks, 8 weeks, 12 weeks & 16 weeks)
- proportions of patients having systemic comorbidities(baseline)
- proportion of patients in each group , aged between 10-18 years, having improvement in quality of life, according to CDLQI(baseline & 16 weeks)
研究者
KUSHAL BRAR
lady hardinge medical college, delhi, india