NCT01295099撤回4 期
Keloid Scarring:A Randomized Clinical and Laboratory Based Study on the Treatment and Differentiation Factors of the Local Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Keloid Scar Reduction
研究概览
简要总结
To clarify the mechanisms of Keloid scar formation.
Elucidate the action and therapeutic value of 5-FU in Keloid scar treatment
Identify the genetic link with Keloid scar formation.
Quantify the psychological/social impact in keloid scarring patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ( > 18 years old).
- •Keloid scarring present.
- •Able to understand and give informed consent.
- •Patients giving informed consent to donate keloidal or non-affected skin when that is redundant after a procedure (i.e. BBR, Abdominoplasty).
- •Patients with a strong familial pedigree of keloid scar formation.
排除标准
- •Open wound at or proximity of the lesion
- •Infected lesion
- •Pregnant or planning pregnancy in the near future
- •Lactating (Breast Feeding)
- •Abnormal renal or liver function tests
- •Atrophic scars
- •Patient under 18 years of age
- •Immunocompromised
- •OR immunosuppressed
研究组 & 干预措施
5-Fluorouracil
Active Comparator
Patients with small keloidal scars to have intralesional 5FU injected
干预措施: 5- fluorouracil (Drug)
Radiotherapy
Active Comparator
Large keloid scars undergo extralesional excision and radiotherapy
干预措施: radiotherapy (Radiation)
TAC
Active Comparator
干预措施: Triamcinolone (Drug)
结局指标
主要结局
Keloid Scar Reduction
时间窗: 18 months
Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Observational Study of Keloids Scars Treated by Shaving and CryosurgeryKeloids ScarsNCT02886091University Hospital, Brest25
进行中（未招募）
1 期
Keloid scars: Pathophysiology and treatmentEUCTR2011-000626-29-GBQUEEN MARY UNIVERSITY OF LONDO100
已完成
不适用
Gene Expression and Biomarker Profiling of Keloid SkinKeloid of Ear LobeHealthy AdultsKeloidNCT03228693Northwestern University48
已完成
不适用
Development of an in vitro keloid scar model for identifying and testing new anti-scar therapies.cheloidkeloidal scar10040899keloidNL-OMON39107Vrije Universiteit Medisch Centrum60
已完成
4 期
A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic ScarsCicatrix, HypertrophicKeloidHypertrophic ScarNCT00754247University of Miami30