jRCTc050190126已完成不适用
Clinical study of autologous noncultured epidermal cell transplantation for leucodelma treatment
未提供0 个研究点目标入组 5 人开始时间: 2019年10月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- repigmentation rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Men and women aged over 20 years old with a diagonosis of stable vitiligo who visited the department of dermatology Osaka University Hospital and who signed a written informed consent by themselves after receiving the explanation of clinical study.
排除标准
- •Apparently unstable patients defined as new areas of depigmentation or enlarging areas of depigmentation within the last 12 months.
- •Patients with treatment of steroid, active vitamin D3, calcineurin inhibitor and light radiation therapy within the 4 weeks befor registration.
- •History of hypertrophic scar, keloid scars or presence of Koebner's phenomenon
- •Patients with allergies to antibiotics and local anaesthetics
- •Patients with tape rash
- •Pregnant women, lactating women and patients who deaire pregnancy during clinical studies.
- •Positive serology of Hepatitis B and C, HIV, HTLV-1
- •Patients who are participating in other clinical studies including interventions or non-interventions such as observation studies.
- •Investigators judge the patiens should not paticipate in the study for any reason
结局指标
主要结局
repigmentation rate
时间窗: before, 3 months after and 6 months after the operation
Evaluation of repigmentation rate of: - cell transplantation area (test site) - suction blister transplantation area (comparison site) - non-treated area (control site) Method: calculating the area of images taken by digital camera
wound areas observation
Observation of the wound areas of: - donor site - test site - comparison site - control site Purpose: safety evaluation
次要结局
- Evaluation of color matching(before, 3 months after and 6 months after the operation)
- Incidence of adverse effects(before, 3 months after and 6 months after the operation)
研究者
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