NCT01923142终止2 期
Double Blind Within-Subject Controlled Study of Autologous Hair Follicle Outer-Root-Sheath Melanocytes Transplantation in the Treatment of Vitiligo
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Repigmentation equal to or greater than 50% of the treated areas from baseline as assessed by image analysis
研究概览
简要总结
The purpose of this study is to evaluate the hypothesis that, in patients with stable vitiligo unresponsive to conventional treatments including traditional phototherapy and/or topical steroids, the application of a non-cultured autologous hair follicle outer-root-sheath melanocytes suspension in the area affected by the disease followed by targeted ultraviolet B (UVB) phototherapy can lead to a significant skin repigmentation. To assess the effect of the proposed treatment, a within-subject controlled study involving selected symmetric lesion areas localized to the back of the hands will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of symmetric lesions of vitiligo at the back of the hands with an extension >5cm²
- •Vitiligo lasting at least one year at the backs of both hands
- •Stable vitiligo, defined as vitiligo that presents no evident evolution (appearance of new lesions or increase in the extension of lesions already present) for at least 6 months
- •Suspension for at least two months prior to the enrollment date of any systemic drug for vitiligo such as immunosuppressive treatment (cyclosporine, systemic steroids) or psoralen + ultraviolet A therapy, phototherapy with ultraviolet B, and of any anticoagulant drug
- •Suspension of topical medications for at least 15 days prior to the enrollment date
排除标准
- •Presence of active vitiligo or Koebner phenomenon
- •Difference of more than 10% in the extension of symmetrical areas of vitiligo
- •Presence of systemic infections or infections localized to the tissues intended for transplantation
- •History of infections to the tissues intended for transplantation (herpes simplex, human papillomavirus infections, pityriasis versicolor, pityriasis alba)
- •Presence or history of malignancy
- •Chemotherapy or radiation therapy in progress
- •History of allergies or adverse reactions to local anesthetics
- •Presence of transmissible diseases (human immunodeficiency virus, hepatitis B and C, human T-lymphotropic virus type I and II, syphilis, cytomegalovirus, Creutzfeldt-Jacob, tuberculosis)
- •Women who are pregnant or intend to become pregnant during the study period (including breastfeeding women)
结局指标
主要结局
Repigmentation equal to or greater than 50% of the treated areas from baseline as assessed by image analysis
时间窗: 12 weeks
次要结局
- Any repigmentation of the treated areas from baseline as assessed by physician according to an ordinal 6-points scale(6 weeks, 12 weeks)
- Any repigmentation of the treated areas from baseline as assessed by patient according to an ordinal 6-points scale(6 weeks, 12 weeks)
- Any repigmentation of the treated areas from baseline as assessed by image analysis(6 weeks, 12 weeks)
- Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale(6 weeks, 12 weeks)
- Any repigmentation of other areas affected by vitiligo from baseline as assessed by physician according to an ordinal 6-points scale (evaluation of a possible systemic effect)(6 weeks, 12 weeks)
研究者
研究点 (4)
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