CTRI/2024/11/076203尚未招募不适用
Comparing efficacy of microneedling with topical 5-Fluorouracil Vs microneedling with topical Tacrolimus in Vitiligo: an interventional study
Commandant, Base hospital delhi cantt1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare the intensity of re – pigmentation following intervention.
研究概览
简要总结
To compare the efficacy of microneedling followed by topical 5 Fluorouracil vs microneedling with topical Tacrolimus in improving intensity and area of pigmentation in patients of Vitiligo. All patients of stable vitiligo meeting and inclusion and exclusion criteria will be offered this treatment which will be participant blinded. patients VASI score initially and at each subsequent visit uptill 3 months of follow up following intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients of stable vitiligo visiting department of dermatology, Base hospital Delhi cantt.
排除标准
- •Pregnant women.
- •Age below 6 years and above 70 years.
- •Lesions over perioral, periocular, patches on the mucosal membrane.
- •Positive Koebner phenomenon.
- •Patients with other autoimmune comorbidities.
- •Patients with coagulation diseases or receiving anticoagulants.
- •Chronic viral infections of HIV, HBV, HCV.
- •High risk of keloid or hypersensitivity to the studied drug.
结局指标
主要结局
To compare the intensity of re – pigmentation following intervention.
时间窗: every month till 3 months & follow up further 3 months
次要结局
- To measure the rate of re – pigmentation in previously depigmented skin lesions.(every month till 3 months & follow up further 3 months)
研究者
Avinash Sai
Base Hospital Delhi Cantonment
研究点 (1)
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