The Use of Botulinum Toxin in the Treatment of Itching From Hypertrophic Scar -- A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The degree of itchiness
研究概览
简要总结
Hypertrophic scar, a disfiguring tissue reaction to trauma, occurred in around 20 % of the population. The patients with hypertrophic scar usually seek medical assistance not just for the annoying appearance but mostly due to the intractable itchiness. There have been a variety of effective methods to alter the appearance of the scar. However, the treatments for itching from hypertrophic scar are scarce. In 2009, P.Gazerani used Botox to treat histamine-induced itch with favorable results. In the clinical setting, however, the efficacy of Botox to treat itch from hypertrophic scar was yet to be proven. Therefore, the goal of this study is to conduct a randomized controlled trials about using Botox to treat itch from hypertrophic scar.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients undergoing laparotomy and thoracotomy in Veterans General Hospital in Kaohsiung (VGHKS) during 2003/1/1~2012/12/31
- •Hypertrophic scars containing more than two itchy sites with itchiness scale >3
- •Good wound healing condition, no infection sign
- •Age older than 20 year-old
排除标准
- •Allergy to Botulinum toxin
- •Inability to express self-willingness
研究组 & 干预措施
Botulinum toxin
5U Botulinum toxin in 1cc normal saline, administered in one of the two itchy points
干预措施: Botulinum Toxins (Drug)
Normal Saline
1cc normal saline, administered in the other itchy point
干预措施: Placebo (Drug)
结局指标
主要结局
The degree of itchiness
时间窗: 6 months
次要结局
- Pain scale(Within one minue after drug injection)
研究者
Kuei-Chang Hsu
Attending Physician
Kaohsiung Veterans General Hospital.