A Comparative Study Between Autologous Mini Punch Grafting, Suction Blister Grafting and Non-Cutured Epidermal Cell Suspension on Resistant Sites in Stable Vitiligo
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Repigmentation At Surgery Site
研究概览
简要总结
Comparing the Efficacy of Three Different Surgical Methods on Resistant Sites in Stable Vitiligo.
详细描述
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 main stay of treatment, it is not effective in all and residual lesions need augmented surgical treatment later for further completion of repigmentation.
Now a day surgical modalities have become treatment of choice for stable vitiligo not responding to medical treatment although there are numerous sites which do not respond that well to surgical procedure as well. The investigators ought to compare the efficacy of 3 well established surgical methods i.e. Mini Punch Grafting vs Suction Blister Epidermal Grafting vs Non Cultured Epidermal cell Suspension on stable vitiligo patches localized to acral areas and bony prominences like elbows, knees and ankles. Out of all the vitiligo patches in a given participant, 3 different patches on acral and bony areas will be chosen and participants will be treated with 3 different methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 inturn 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
- •Pregnancy and lactation
- •Patient with actively spreading vitiligo
- •History of Koebnerisation
- •History of hypertrophic scars or keloidal tendency
- •Bleeding disorders
- •Patients with unrealistic expectation
研究组 & 干预措施
Non Cultured Epidermal Cell Suspension
干预措施: NON CULTURED EPIDERMAL CELL SUSPENSION (Procedure)
Mini Punch Grafting
干预措施: MINI PUNCH GRAFTING (Procedure)
Suction Blister Epidermal Grafting
干预措施: SUCTION BLISTER EPIDERMAL GRAFTING (Procedure)
结局指标
主要结局
Repigmentation At Surgery Site
时间窗: Repigmentation will be assessed at 12 weeks.
To assess the difference in extent of repigmentation of the surgery site by three different methods at 12 weeks of post treatment follow up in a given patient. Repigmentation will be assessed as follows: ≤25% Minimal repigmentation 26-50% Mild repigmentation 51-75% Moderate repigmentation 76-90% Marked repigmentation \>90% Excellent repigmentation
次要结局
- Color Matching of Repigmented Area(Assessment at 12 weeks.)
- PATTERN OF REPIGMENTATION(Assessment at 12 weeks.)
- ADVERSE EVENTS(Assessment at 4, 8 and 12 weeks.)
- Patient's Quality of Life Post Surgery(Assessment at 12 weeks.)
研究者
Davinder Parsad
PROFESSOR, DEPARTMENT OF DERMATOLOGY
Post Graduate Institute of Medical Education and Research, Chandigarh