Clinical trial NCT03294382: Botulinum Toxin to Improve Results in Epicanthoplasty
Official title: Botulinum Toxin to Improve Results in Epicanthoplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Scar
Intercanthal Distance Ratio
Keywords: epicanthoplasty
Botulinum Toxins
scar
intercanthal distance
blepharoplasty
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Vancouver Scar scale
timeFrame: 6 month
measure: intercanthal distance ratio
timeFrame: 6 month
Secondary outcomes:
measure: Photographic measurement
timeFrame: 6 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ru-Lin Huang
Study officials:
References:
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