A Comparative study between Autologous Mini punch grafting, Suction blister grafting and Non Cultured Epidermal cell suspension on resistant sites in stable vitiligo.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To assess the difference in extent of repigmentation by three different methods at 12 weeks of post treatment follow up in a given patient.
研究概览
简要总结
The treatment of vitiligo includes both medical and surgical modalities, whose goal is to restore melanocytes to the depigmented skin so that the epidermis restores back to normal morphology and functions. Although medical treatment is the mainstay of treatment, it is not effective all and residual lesions need augmented surgical treatment for further completion of repigmentation. Also there are certain areas that are difficult to repigment such as vitiligo patches on joints and bony prominences, lips, genitalia, dorsum of hands and feet especially fingers and toes. Proper selection of cases for surgical therapy is of paramount importance and stability of vitiligo is taken as the most important parameter before opting for any surgical intervention. The recommended period of stabilty in different studies varied widely from 4 months to 3 years, but none of these criteria were based on evidence obtained from systematic research.
Not many studies have been conducted analyzing the efficacy of various surgical modalities in vitiligo patches located over treatment refractory areas like acral and bony sites, genital areas,lips, palms and soles. Through this study we shall compare the effectiveness of 3 well established surgical methods - Autologous Mini Punch grafting, Suction blister epidermal grafting and Non cultured epidermal cell suspension on treatment resistant vitiligo lesions present over bony prominences and acral areas( mainly distal areas) with regards to extent of repigmentation, color matching of repigmented area, patient satisfaction and adverse effects if any.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with clinical diagnosis of focal, segmental or generalized vitiligo.
- •Patients with lesions of size > 1.5cm x 1cm present on acral areas and bony prominences.
- •Vitiligo lesions has been stable for 1 year.
- •Disease not responding to medical treatment or there are residual patches (after medical therapy) of vitiligo which in turn are located on acral areas and bony prominences.
- •Maximum size of vitiligo patches to be selected for surgery will not be >100cm2.
排除标准
- •Age less than 18 years 2)Pregnancy and lactation 3)Patient with actively spreading vitiligo 4)History of Koebnerisation 5)History of hypertrophic scars or keloidal tendency 6)Bleeding disorders 7) Patients with unrealistic expectation.
结局指标
主要结局
To assess the difference in extent of repigmentation by three different methods at 12 weeks of post treatment follow up in a given patient.
时间窗: Follow up will be done on Day 8, then at 4, 8 and 12 weeks.
次要结局
- 1. Pattern of repigmentation(attained post-procedure.)