Botulinum Toxin to Improve Results in Epicanthoplasty

Phase 3

• Conditions: Intercanthal Distance Ratio; Scar
• Interventions: Drug: Placebo; Drug: Botulinum toxin type A

• Registration Number: NCT03294382
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Status Verified: 2017-09
• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-22
• Last Update Submitted: 2017-09-22
• Study First Posted: 2017-09-27
• Last Update Posted: 2017-09-27
• Primary Completion: 2018-02-01
• Study Completion: 2018-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Placebo	0.1 mL normal saline, administered in the other intercanthus
Botulinum toxin	Botulinum toxin type A	5U Botulinum toxin in 0.1 mL normal saline, administered in one of the intercanthus

Primary Outcome Measures

Name	Time	Method
intercanthal distance ratio	6 month	the ratio of the intercanthal distance to the interpupillary distance
Vancouver Scar scale	6 month	Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ru-Lin Huang; 🇨🇳 Shanghai, China