A comparative study between recipient site preparation using manual dermabrasion and electrofulguration assisted dermabrasion in autologous non cultured epidermal cell suspension procedure in stable vitiligo patients and correlation of growth factors in the cell suspension with clinical response
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the percentage of patients achieving 75 percent repigmentation with respect to the two different methods at 24 weeks of follow up post treatment
研究概览
简要总结
Vitiligo is a common acquired disorder of pigmentation and causes considerable cosmetic disfigurement and psychological distress to patients. Surgical therapy is a good treatment option for stable patches not responding to conventional methods of therapy. The gold standard of recipient site preparation in NCES procedure is manual dermabrasion. However our centre has reported good outcome with recipient site preparation using electrofulguration assisted dermabrasion. In this study we propose to compare the repigmentation rates using the two methods of recipient site preparation. In addition, the keratinocytes in the cell suspension are a rich source of various growth factors which stimulate the melanocytes to produce melanin and cause repigmentation. Hence we wish to correlate the levels of growth factors like SCF, bFGF, Endothelin 1 in the cell suspension with the repigmentation rates post surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 0.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical diagnosis of segmental or non segmental vitiligo 2 independent patchesbof 3x 3 cm size each present symmetrically or unilaterally over the same part or a single patch ofvsize 6x6 cm Stable leaions for more than 1 year Disease is not responding to medical therapy for 12 weeks or residual patches post medical therapy.
排除标准
- •Pregnancy and lactation History of unstable cardiac diseasevor pacemakers Patients with active disease VIDA more than 1 History of hypertrophic scars or keloid Skin infection Patients with unrealistic expectations History of bleeding disorders Patients on anticoagulants Immunosuppressed patients Patients still in wash off period of therapy that is 4 weeks for topical and 12 weeks for systemic therapy.
结局指标
主要结局
To assess the percentage of patients achieving 75 percent repigmentation with respect to the two different methods at 24 weeks of follow up post treatment
时间窗: 0 4 8 12 16 24 weeks
次要结局
- To assess whether the extent of repigmentation has any correlation to the expression levels of growth factors which are SCF, bFGF, endothelin 1(0 4 8 12 16 24 weeks)
- To evaluate the repigmentation patterns of the lesions pre and post post procedure by dermoscopy and to ennumerate the dermatoscopic markers of repigmentation as well markers of success of the procedure(0 4 8 12 16 24 weeks)