Botulinum Toxin to Improve Results in Epicanthoplasty

Scar Clinical Trial

Official title:

Botulinum Toxin to Improve Results in Epicanthoplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03294382
• Other study ID #: 9hospital
• Status: Recruiting
• Phase: Phase 3
• First received: September 22, 2017
• Last updated: September 22, 2017
• Start date: April 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: September 2017
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: April 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Intercanthal Distance Ratio
• Scar

Intervention

Drug:
• Botulinum 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
• Placebo
0.1 mL normal saline, injected in two points at one side, 0.05 mL per point, local injection

Locations

Country	Name	City	State
China	Ru-Lin Huang	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (10)

Al-Qattan MM, Al-Shanawani BN, Alshomer F. Botulinum toxin type A: implications in wound healing, facial cutaneous scarring, and cleft lip repair. Ann Saudi Med. 2013 Sep-Oct;33(5):482-8. doi: 10.5144/0256-4947.2013.482. Review. — View Citation

Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair. Plast Reconstr Surg. 2014 Sep;134(3):511-6. doi: 10.1097/PRS.0000000000000416. — View Citation

Chang CS, Wallace CG, Hsiao YC, Chang CJ, Chen PK. Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial. PLoS One. 2014 Dec 26;9(12):e115690. doi: 10.1371/journal.pone.0115690. eCollection 2014. — View Citation

Elhefnawy AM. Assessment of intralesional injection of botulinum toxin type A injection for hypertrophic scars. Indian J Dermatol Venereol Leprol. 2016 May-Jun;82(3):279-83. doi: 10.4103/0378-6323.173586. — View Citation

Kim YS, Lee HJ, Cho SH, Lee JD, Kim HS. Early postoperative treatment of thyroidectomy scars using botulinum toxin: a split-scar, double-blind randomized controlled trial. Wound Repair Regen. 2014 Sep-Oct;22(5):605-12. doi: 10.1111/wrr.12204. Epub 2014 Aug 26. — View Citation

Kwon B, Nguyen AH. Reconsideration of the Epicanthus: Evolution of the Eyelid and the Devolutional Concept of Asian Blepharoplasty. Semin Plast Surg. 2015 Aug;29(3):171-83. doi: 10.1055/s-0035-1556849. — View Citation

Robinson AJ, Khadim MF, Khan K. Keloid scars and treatment with Botulinum Toxin Type A: the Belfast experience. J Plast Reconstr Aesthet Surg. 2013 Mar;66(3):439-40. doi: 10.1016/j.bjps.2012.08.042. Epub 2012 Oct 23. — View Citation

Shaarawy E, Hegazy RA, Abdel Hay RM. Intralesional botulinum toxin type A equally effective and better tolerated than intralesional steroid in the treatment of keloids: a randomized controlled trial. J Cosmet Dermatol. 2015 Jun;14(2):161-6. doi: 10.1111/j — View Citation

Zelken J, Yang SY, Chang CS, Chang CJ, Yang JY, Chuang SS, Chen HC, Hsiao YC. Donor Site Aesthetic Enhancement With Preoperative Botulinum Toxin in Forehead Flap Nasal Reconstruction. Ann Plast Surg. 2016 Nov;77(5):535-538. doi: 10.1097/SAP.0000000000000625. — View Citation

Zhang DZ, Liu XY, Xiao WL, Xu YX. Botulinum Toxin Type A and the Prevention of Hypertrophic Scars on the Maxillofacial Area and Neck: A Meta-Analysis of Randomized Controlled Trials. PLoS One. 2016 Mar 17;11(3):e0151627. doi: 10.1371/journal.pone.0151627. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vancouver Scar scale	Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U	6 month
Primary	intercanthal distance ratio	the ratio of the intercanthal distance to the interpupillary distance	6 month
Secondary	Photographic measurement	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.	6 month