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Botulinum Toxin to Improve Results in Epicanthoplasty

NCT ID: NCT03294382

Last Updated: 2017-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-04-01

Brief Summary

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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

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Conditions

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Scar Intercanthal Distance Ratio

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Botulinum toxin

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

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type DRUG

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

Normal Saline

0.1 mL normal saline, administered in the other intercanthus

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Ru-Lin Huang

Ph.D., M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ru-Lin Huang

Shanghai, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Ru-Lin Huang, Ph.D., M.D.

Role: primary

[email protected]
86-15821950669

Chia-Kang Ho, M.D.

Role: backup

[email protected]
86-13817381588

References

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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.

Reference Type BACKGROUND
PMID: 25541942 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25158709 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24188943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26418784 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24898579 (View on PubMed)

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.

Reference Type RESULT
PMID: 26306084 (View on PubMed)

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.

Reference Type RESULT
PMID: 27088929 (View on PubMed)

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.

Reference Type RESULT
PMID: 25810045 (View on PubMed)

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.

Reference Type RESULT
PMID: 23092904 (View on PubMed)

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.

Reference Type RESULT
PMID: 26985661 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31568286 (View on PubMed)

Other Identifiers

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9hospital

Identifier Type: -

Identifier Source: org_study_id