Evaluation of comparative efficacy of topical tacrolimus 0.1% vs topical tofacitinib 2% in non segmental vitiligo 2% in non-segmental vitiligo
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Amount of repigmentation of lesions as assessed by Vitiligo Disease Improvement Score (VDIS)
研究概览
简要总结
This study aims to compare the efficacy and safety of topical tacrolimus 0.1% and topical tofacitinib 2% in the treatment of vitiligo. Vitiligo is a common acquired depigmenting disorder with limited therapeutic options. Topical calcineurin inhibitors like tacrolimus are widely used, whereas topical Janus kinase (JAK) inhibitors like tofacitinib are emerging as promising alternatives.
This is a 16 week, randomized, open label, parallel group clinical trial involving patients with stable, non segmental vitiligo. Eligible participants will be randomized to receive either topical tacrolimus 0.1% ointment or topical tofacitinib 2% cream applied twice daily. The primary endpoint will be the percentage of repigmentation assessed using the Vitiligo Disease Improvement Score(VDIS) at week 16. Safety and local tolerability will also be assessed.
The study will be conducted at a tertiary care dermatology center and aims to contribute evidence regarding the comparative role of JAK inhibitors in the topical treatment of vitiligo.
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
- 5.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 5 years 2) Clinical diagnosis of non-segmental vitiligo 3)Body surface area involvement less than or equal to 10% 4) Stable vitiligo (no new lesions in last 12 weeks) 5) Willingness for a 2 week washout if on prior topical therapy.
排除标准
- •Segmental vitiligo 2) Pregnant or lactating women 3) Allergy to study medications 4) Recent (within 4 weeks) systemic immunosuppressants or phototherapy.
结局指标
主要结局
Amount of repigmentation of lesions as assessed by Vitiligo Disease Improvement Score (VDIS)
时间窗: Baseline, Weeks 4, 8, 12, 16
次要结局
- Objective assessment using physician global assessment scale(Baseline, Weeks 4, 8, 12, 16)
- Time to visible repigmentation(Baseline, Weeks 4, 8, 12, 16)
- Patient satisfaction (VNS Score)(Baseline, Weeks 4, 8, 12, 16)
- Adverse effects(Baseline, Weeks 4, 8, 12, 16)
研究者
Dr Itee Gaur
Government Medical College and Hospital, Chandigarh