Botulinum Toxin to Improve Results in Epicanthoplasty

NCT03294382 | Unknown Phase 3 DMC

• 1 other identifier: 9hospital
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Scar; Intercanthal Distance Ratio

Keywords

epicanthoplasty; Botulinum Toxins; scar; intercanthal distance; blepharoplasty

Outcome Measures

Primary Outcomes (2)

• Vancouver Scar scale

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

  6 month

• intercanthal distance ratio

  the ratio of the intercanthal distance to the interpupillary distance

  6 month

Secondary Outcomes (1)

• Photographic measurement

  6 month

Study Arms (2)

Botulinum toxin

EXPERIMENTAL

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

Drug: Botulinum toxin type A

Normal Saline

PLACEBO COMPARATOR

0.1 mL normal saline, administered in the other intercanthus

Drug: Placebo

Interventions

Botulinum toxin type A DRUG

5U botulinum toxin in 0.1 mL normal saline, injected in two points at one side, 2.5U per point, local injection

Botulinum toxin

Placebo DRUG

0.1 mL normal saline, injected in two points at one side, 0.05 mL per point, local injection

Normal Saline

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ru-Lin Huang

Shanghai, 200011, China

RECRUITING

Related Publications (11)

• 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.

  PMID: 25541942 BACKGROUND

• 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):511-516. doi: 10.1097/PRS.0000000000000416.

  PMID: 25158709 BACKGROUND

• 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.

  PMID: 24188943 BACKGROUND

• 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.

  PMID: 26418784 BACKGROUND

• 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.

  PMID: 24898579 BACKGROUND

• 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.

  PMID: 26306084 RESULT

• 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.

  PMID: 27088929 RESULT

• 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/jocd.12134. Epub 2015 Mar 24.

  PMID: 25810045 RESULT

• 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. No abstract available.

  PMID: 23092904 RESULT

• 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. eCollection 2016.

  PMID: 26985661 RESULT

• Huang RL, Ho CK, Tremp M, Xie Y, Li Q, Zan T. Early Postoperative Application of Botulinum Toxin Type A Prevents Hypertrophic Scarring after Epicanthoplasty: A Split-Face, Double-Blind, Randomized Trial. Plast Reconstr Surg. 2019 Oct;144(4):835-844. doi: 10.1097/PRS.0000000000006069.

  PMID: 31568286 DERIVED

MeSH Terms

Conditions

Cicatrix

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., M.D.

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 27, 2017
• Study Start: April 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: September 27, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)