NCT02155439已完成4 期
Treatment of Keloidscars With Intralesional Triamcinolone and 5-fluorouracil Injections-prospective, Randomized, Controlled Trial - Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Symptoms (pain, itching) of keloids and appearance of keloid
研究概览
简要总结
The aim of study is examine the efficacy of intralesional 5-fluorouracil injections in keloid disease treatment.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Person who has a keloidscar which could be treated with injection treatment
排除标准
- •Pregnancy, lactating, renal or liver failure
研究组 & 干预措施
Triamcinolone
Active Comparator
kortikosteroid
干预措施: 5-fluorouracil (Drug)
5-fluorouracil
Active Comparator
antimitotic drug
干预措施: Triamcinolone (Drug)
结局指标
主要结局
Symptoms (pain, itching) of keloids and appearance of keloid
时间窗: baseline and one year
Change from baseline symptoms of scars baseline at one year with POSAS score
次要结局
- Concentration change of hemoglobin and melanin(0 week, 3 week, 6 week, 12 week, 1 year)
研究者
Kristiina Hietanen
MD
Tampere University Hospital
研究点 (1)
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