Intralesional Injection of Steroids and/or Botulinum Toxin Type A in Hypertrophic Scars and Keloids for Pain Improvement
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Scar pain relief
研究概览
简要总结
Botulinum toxins has been approved by the FDA to treat chronic migraine. Botox had been shown to inhibiting the release of inflammatory mediators and peripheral neurotransmitters from sensory nerve to treat neuropathic pain. In the clinical practice, botox indeed effect in scar pain. However, investigators need well controlled study to prove this finding and assess the improvement of scar appearance.
详细描述
After surgery or trauma, scar tissues would form during the healing process. However, hypertrophic scars and keloids might happen to some patients, both of which are often pruritic and erythematous. Besides, the markedly elevated tumor-like appearance usually brings much concern to patients. Moreover, significant pain or discomfort could happen to keloids. Various treatment strategies were mentioned but without a solid solution to all of the scars. Investigators hope to evaluate the differences of scar volume, appearance and symptoms (itching and pain) in participants receiving simultaneous intralesional injection of Botulinum toxin type A and/or steroids. Besides, side effects would also be recorded. Investigators hope to establish a more effective intralesional injection therapy for participatns suffering from hypertrophic scars and keloids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (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
- •Patients have visible hypertrophic scars or keloids over three months after trauma or surgery.
- •Patients have symptoms of pain, itching or erythema.
排除标准
- •Patients had either Botulinum toxin type A or Triamcinolone intralesional before in the same scar
- •The scar size is larger than 10 cm2
- •Immunocompromised status
- •Systemic infection status
- •Allergic to Botulinum toxin type A or steroids
研究组 & 干预措施
control group
0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume
干预措施: Triamcinolone (Drug)
control group
0.9% Normal saline 0.1 ml +Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1cm2 scar volume
干预措施: Lidocaine (Drug)
botox group
4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume
干预措施: Triamcinolone (Drug)
botox group
4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume
干预措施: Lidocaine (Drug)
botox group
4U Botox® diluted to 0.1 ml + Triamcinolone 4mg diluted to 0.1 ml + 0.1ml 2% Xylocaine per 1 cm2 scar volume
干预措施: Botulinum toxin A (Drug)
结局指标
主要结局
Scar pain relief
时间窗: Change from baseline scar pain during 16 weeks after drug injection
assessed by score 0,1,2 (0: no pain, 1: sometimes feel pain, 2: need medication)
scar appearance
时间窗: Change from baseline scar appearance during 16 weeks after drug injection
assessed by vancouver scar scale(vascularity, pigmentation, pliability, height)
itch
时间窗: Change from baseline itch sensation during 16 weeks after drug injection
assessed by score 0,1,2 (0: no itch, 1: sometimes feel itch, 2: need medication)
次要结局
未报告次要终点
研究者
Sheng-Hua Wu
Attending Physician, anesthesiology
Kaohsiung Medical University