Botulinum Toxin to Improve Results in Epicanthoplasty

September 22, 2017 updated by: Ru-Lin Huang, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200011
        • Recruiting
        • Ru-Lin Huang
        • Contact:
          • Ru-Lin Huang, Ph.D., M.D.
          • Phone Number: 86-15821950669
          • Email: hrl222@163.com
        • Contact:
        • Principal Investigator:
          • Tao Zan, Ph.D., M.D.
        • Sub-Investigator:
          • Ru-Lin Huang, Ph.D., M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botulinum toxin
5U Botulinum toxin in 0.1 mL normal saline, administered in one of the intercanthus
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 Comparator: Normal Saline
0.1 mL normal saline, administered in the other intercanthus
Drug: Placebo
0.1 mL normal saline, injected in two points at one side, 0.05 mL per point, local injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vancouver Scar scale
Time Frame: 6 month
Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U
6 month
intercanthal distance ratio
Time Frame: 6 month
the ratio of the intercanthal distance to the interpupillary distance
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Photographic measurement
Time Frame: 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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

September 22, 2017

First Submitted That Met QC Criteria

September 22, 2017

First Posted (Actual)

September 27, 2017

Study Record Updates

Last Update Posted (Actual)

September 27, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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