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临床试验/NCT03294382
NCT03294382Unknown3 期

Botulinum Toxin to Improve Results in Epicanthoplasty

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
42
试验地点
1
主要终点
Vancouver Scar scale

研究概览

简要总结

Medial epicanthal fold is a common skin fold in the inner part of the eye in more than 50% Asia population, giving the illusion of a shorter palpebral fissure length and a wider intercanthal distance. Currently, various epicanthoplasty techniques have been well described to correct epicanthus fold. However, hypertrophic scarring after epicanthoplasty remains a clinical challenge, which seems inevitable and may leading to unpleasing supratarsal crease, recurrence of medial epicanthus fold, even obvious scar formation. Botulinum toxin type A (BTX-A) is widely used for facial rejuvenation and many other medical indications. It is a potent neurotoxin that indirectly blocks neuromuscular transmission and leads to functional denervation of striated muscle for 2 to 6 months after injection. Recently, experimental study and clinical trails have revealed that BTX-A can inhibit the growth of fibroblasts derived from hypertrophic scars and influenced the expression of transforming growth factor-β1. Therefore, we hypothesized that BTX-A can improve hypertrophic scarring after epicanthoplasty through release orbicularis oculi muscle tension, inhibit fibroblast growth, and reduce collagen production. The main aim of this trail is to evaluate the efficiency of BTX-A injection on improving hypertrophic scaring after epicanthoplasty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with moderate to severe congenital epicanthus.
  • patients accept Park Z epicanthoplasty.
  • Written informed consent given

排除标准

  • epicanthus caused by trauma, surgical injury.
  • patients with both epicanthus and blepharopotosis.
  • patients with blepharophimosis-ptosis-epicanthus inversus syndrome, or only inversus epicanthus
  • patients underwent Botulinum Toxin Type A periocular injection within 6 months
  • patients ever have been allergic to Botulinum Toxin Type A or any components of Botulinum Toxin Type A

研究组 & 干预措施

Botulinum toxin

Experimental

5U Botulinum toxin in 0.1 mL normal saline, administered in one of the intercanthus

干预措施: Botulinum toxin type A (Drug)

Normal Saline

Placebo Comparator

0.1 mL normal saline, administered in the other intercanthus

干预措施: Placebo (Drug)

结局指标

主要结局

Vancouver Scar scale

时间窗: 6 month

Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U

intercanthal distance ratio

时间窗: 6 month

the ratio of the intercanthal distance to the interpupillary distance

次要结局

  • Photographic measurement(6 month)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ru-Lin Huang

Ph.D., M.D.

Shanghai Jiao Tong University School of Medicine

研究点 (1)

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