Intercanthal Distance Ratio, Scar
Conditions
Keywords
epicanthoplasty, Botulinum Toxins, scar, intercanthal distance, blepharoplasty
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.
Interventions
DRUGBotulinum toxin type A
5U botulinum toxin in 0.1 mL normal saline, injected in two points at one side, 2.5U per point, local injection
DRUGPlacebo
0.1 mL normal saline, injected in two points at one side, 0.05 mL per point, local injection
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vancouver Scar scale | 6 month | Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U |
| intercanthal distance ratio | 6 month | the ratio of the intercanthal distance to the interpupillary distance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Photographic measurement | 6 month | The scar width of the patient's picture at 6 month after surgery will be measured using photoshop CS3 extended. One ruler will be placed on the patient's nose before taken the photo. Then the scar width could be measured. |
Countries
China
Outcome results
None listed