A comparative study evaluating the efficacy of non-cultured epidermal cell suspension (NCES) versus no laboratory epidermal cell paste(NLEP) in stable vitiligo: A randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To compare NCES and NLEP cellular grafting techniques in stable vitiligo regarding the percentage of repigmentation in lesions.
研究概览
简要总结
The study is a prospective, simple randomized clinical trial, recruiting patients from the department of Dermatology, Venereology and Leprology OPD, AIIMS, Jodhpur. The patches will be randomised with group 1 and group 2. If one patient has two patches, the upper and left patch will be recruited to the randomised group and the other patch will automatically allocated the other group. Patches in group 1 will undergo standard NCES procedure and those in group 2 will undergo NLEP. Patients will be followed up in OPD on day 8 (dressing removal), and 1st, 2nd, 3rd and 4th month after the transplantation. Percentage of repigmentation assessment as per graphical assessment will be done.
Research question is to compare the efficacy and safety of standard noncultured epidermal cell suspension (NCES) method with newer no laboratory epidermal paste (NLEP) modification in stable vitiligo patches.
Primary objective is to compare NCES and NLEP cellular grafting techniques in stable vitiligo regarding the percentage of repigmentation.
Secondary objective is to compare pattern and colour of re-pigmentation of vitiligo lesion, adverse effects profile in NCES and NLEP, the difference in the viability of melanocytes between the two techniques and to compare quality of life measured using VIS22 score.
Incusion criteria is stable vitiligo patches with either lack of progression of old lesions within the past 1 year or repigmentation of depigmented areas, lesions not responding to medical management, Age ≥15 years
Exclusion criteria is presence of any of the following: immunocompromised, comorbidities like uncontrolled diabetes, hypertension, Chronic diseases affecting wound healing, kidney, liver, chronic congestive failure, Bleeding diathesis, History of hypertrophic scar or keloid, Pregnancy, Age below 15 years, Denied consent or Viral HIV, HBsAg or HCV status
We are expecting NLEP to be non-inferior to NCES.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patches of vitiligo with
- •Either lack of progression of old lesions within the past 1 year or repigmentation of depigmented areas
- •Lesions not responding to medical management
- •Age ≥15 years.
排除标准
- •1.Presence of any of the following: immunocompromised, comorbidities like uncontrolled diabetes, hypertension.
- •Chronic diseases affecting wound healing: kidney, liver, chronic congestive failure
- •Bleeding diathesis
- •History of hypertrophic scar or keloid
- •Pregnancy
- •Age below 15 years
- •Denied consent
- •Positive for HIV, HBsAg or HCV.
结局指标
主要结局
To compare NCES and NLEP cellular grafting techniques in stable vitiligo regarding the percentage of repigmentation in lesions.
时间窗: 4 months post intervention
次要结局
- To compare the pattern and colour of repigmentation of vitiligo lesion(4 months after intervention)
- To compare the difference in adverse effects profile between NCES and NLEP(at baseline and 4 months after intervention)
- To compare the difference in the viability of melanocytes between the two techniques using trypan blue staining(at the time of intervention)
- To compare quality of life measured using a validated tool(at baseline and 4 months after intervention)
研究者
Anil Budania
AIIMS JODHPUR