NCT02156427已完成3 期
A Multicenter Double-blind Placebo-controlled Trial of Non-cultured Epidermal Cellular Grafting Versus Hyaluronic Acid for Repigmenting Stable Leukoderma (Vitiligo and Piebaldism)
Laboratoires Genévrier5 个研究点 分布在 3 个国家目标入组 38 人开始时间: 2014年4月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- Rate of successful repigmentation
研究概览
简要总结
The purpose of this study is to assess the efficacy of autologous epidermal cells suspension grafting using a newly developed device named VITICELL® compared to placebo.
The secondary objective is to evaluate safety of VITICELL® and global satisfaction of patient and investigator.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged over 18 years old with a diagnosis of non-scaring leukoderma that has been stable over the last 2 years (non-segmental, segmental vitiligo and piebaldism)
- •For non-segmental vitiligo: symmetrical vitiligo lesions, or parts of a lesion. A part of at least 1 cm2 (1 x 1 cm), but preferable 4 cm2 (2x2 cm) and preferably in the center of each lesions (left/right) should be treated.
- •The minimum distance between the normal pigmented skin and the test area should preferably be at least 0.5 cm.
- •For segmental vitiligo lesion and piebaldism: all lesions possible if two parts of at least 1 cm2 (1 x 1 cm), but preferably 4 cm2 (2 x 2 cm) in the lesion can be treated. The minimum distance between the 2 areas should be 2 cm and between test areas and to the normal pigmented skin preferably at least 0.5 cm.
- •Medical treatments of vitiligo failed (in case of vitiligo: at least cream treatment for 6 months).
- •Absence of infected lesion
- •Negative serology (HIV-hepatitis B and C- Syphilis)
- •Without treatment one month for cream and 3 months for phototherapy
排除标准
- •Hypersensibility to local anaesthetics or one of the components of the device (trypsin, hyaluronic acid)
- •Indication against biopsies
- •Patient with a history of melanoma
- •Positive serology (ongoing serious systemic disease, herpes, HIV, hepatitis B and C-Syphilis)
- •Positive pregnancy test
- •History of keloidal scars and presence of Koebner's phenomenon (type 1 and type 2b)
- •Infected lesion
- •Test areas not on fingers and toes vitiligo areas in case of non-segmental vitiligo
- •Test areas not on facial non segmental vitiligo
- •Pregnant women, or lactating
- •Age <18years
- •Major deprived of their freedom by administrative or legal decision, or being the subject of a legal protection measure, or out of state to express their consent
研究组 & 干预措施
VITICELL
Experimental
In this arm, lesions will be treated by autologous epidermal cells suspension (containing hyaluronic acid) obtained after VITICELL kit's use, a class III medical device.
干预措施: VITICELL (Device)
PLACEBO
Placebo Comparator
In this arm, lesions will be treated by a suspension of hyaluronic acid without epidermal cells.
干预措施: PLACEBO (Device)
结局指标
主要结局
Rate of successful repigmentation
时间窗: at month 6
succesful repigementation define as more than or equal to 50% repigmentation of the treated area
次要结局
- Rate of successful repigmentation(at month 12)
研究者
研究点 (5)
Loading locations...
相似试验
Unknown
3 期
Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust MitesAllergic RhinitisNCT01013116Roxall Medizin120
Unknown
3 期
A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen ExtractsAllergic ConjunctivitisAllergic RhinitisNCT01012752Roxall Medizin150
暂停
不适用
Autologous Cellular Graft in Surgical Treatment of VitiligoVitiligo, GeneralizedNCT05503368Cairo University20
进行中（未招募）
3 期
Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical RemissionGiant Cell ArteritisNCT05380453Novartis Pharmaceuticals151
撤回
4 期
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer SubjectsOpioid-Induced ConstipationNCT00858754Bausch Health Americas, Inc.