A Study to access the efficacy of cultured pluckedhair follicle outer root sheath melanocyte fortransplantion in stable vitiligo
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- AIIMS
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Repigmentation
研究概览
简要总结
Vitiligo is a common acquired depigmenting disorder with significant psychological distress. Surgical treatment is indicated for depigmented areas not responding to medical treatment in stable disease. When large surface area needs to be covered we need more no. of melanocytes. So melanocyte culture is an important modality to provide this motive. If we are able to culture melanocytes from a renewable source like plucked hair follicle it can be a major breakthrough in vitiligo research and treatment. In this study, we will try to culture melanocyte from plucked hair follicle and transplant in to patients vitiligo lesion. As a pilot study we kept sample size of 5 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with clinical diagnosis of segmental or generalized vitiligo
- •Vitiligo should have been stable for at least two year or more to be included in the study.
- •The patient should have at least one large patch of 16 cm2 or more will be taken.
排除标准
- •1.Age less than 18yrs 2.Pregnancy 3.Koebnerization 4.Keloid or bleeding diathesis 5.Active infection at the site 6.Other autoimmune diseases 7.Inability to come for follow-up for at least 6 months 8.Patients with involvement of only acral sites and bony prominences.
结局指标
主要结局
Repigmentation
时间窗: Repigmentation:4,8,12,16,20,24 weeks
次要结局
- Patient’s satisfaction about the procedure(6 months)
