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临床试验/CTRI/2017/12/010980
CTRI/2017/12/010980已完成不适用

A comparative study between trasplantation of autologus non-cultured epidermal cell suspension prepared by conventional laboratory method versus four chamber method in stable vitiligo

Postgraduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2014年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Extent of repigmentation

研究概览

简要总结

Non cultured epidermal cell suspension (NCES) is a well established cellular grafting technique in stable vitiligo. However, NCES preparation by Lab conventionally involves creation of laboratory facilities and need for special equipments. There is no need for trypsin inhibitors, pipettes, autoclaved tips, centrifuge tube and centrifuge machine in Four chamber (FC) method. With the introduction of  FC method the clinician’s in a small set up who do not have access to laboratory facilities will be able to perform vitiligo surgeries at peripheral level at a minimal cost. A total of 30 stable vitiligo patients with bilaterally symmetrical patches or multiple patches in same anatomical area were recruited for the study. Using random number tables the matched patches were treated with either conventional NCES or NCES prepared by FC method in same patient. Each patient was evaluated at 4, 8, 16 weeks post surgery by a blinded observer in regard to extent of repigmentation, colour match, change in patient satisfaction with patient global assessment (PGA) questionnaire. In the study at the follow up period of 16 weeks, the extent of repigmentation was excellent 36.6% in group A compared to 34.1%in group B which showed no statistical significance (p=1.00).  Marked repigmentation was also seen in in 34.1% of patches in each group. Diffuse repigmentation was seen in 29 (70.7%) out of 41 lesions in group A and 31 (75.6%) out of 41 lesions in group B (p=0.62). On resistant sites repigmentation was good, 33.3% in group A and 27.8% in group B (p=0.72); while it was excellent, 22.2% each in group A and B. Thirty four paired patches were of  either vitiligo vulgaris and acrofacialvitiligo) in which repigmentation was good, 38.2 % in group A and 35.3 % in group B (p=0.80); while it was excellent in 32.4 % in group A and 29.4 % in group B (p=0.79). There was also no statistical difference in the pattern of repigmentation, colour match and PGA. It can be concluded that preparation of NCES by FC method is efficacious and a cost effective cellular transplantation technique in stable vitiligo with results comparable to conventional NCES.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Outcome Assessor Blinded

入排标准

年龄范围
10.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • •Subjects with clinical diagnosis of focal, segmental or generalized vitiligo which has been stable for more than 1year.
  • •Vitiligo patches should be in same anatomical region bilaterally or two or more patches in the same anatomical region separated by a stretch of normal skin (at least 1cm).

排除标准

  • •Age less than 10 years 2)Pregnancy 3)Patient with actively spreading vitiligo 4)Appearance of new lesions 5)History of Koebnerization 6)History of hypertrophic scars or keloidal tendency 7)Bleeding disorders 8)Patients with unrealistic expectation.

结局指标

主要结局

Extent of repigmentation

时间窗: 16 weeks

次要结局

  • Pattern of repigmentation.(Correlation extent of repigmentation with type of vitiligo and site of surgery)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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