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Botulinum Toxin to Improve Results in Epicanthoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294382
Recruitment Status : Unknown
Verified September 2017 by Ru-Lin Huang, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ru-Lin Huang, 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.

Condition or disease Intervention/treatment Phase
Scar Intercanthal Distance Ratio Drug: Botulinum toxin type A Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Botulinum Toxin to Improve Results in Epicanthoplasty
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : February 1, 2018
Estimated Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

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




Primary Outcome Measures :
  1. Vancouver Scar scale [ Time Frame: 6 month ]
    Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U

  2. intercanthal distance ratio [ Time Frame: 6 month ]
    the ratio of the intercanthal distance to the interpupillary distance


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294382


Locations
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China
Ru-Lin Huang Recruiting
Shanghai, China, 200011
Contact: Ru-Lin Huang, Ph.D., M.D.    86-15821950669    hrl222@163.com   
Contact: Chia-Kang Ho, M.D.    86-13817381588    610542307@qq.com   
Principal Investigator: Tao Zan, Ph.D., M.D.         
Sub-Investigator: Ru-Lin Huang, Ph.D., M.D.         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ru-Lin Huang, Ph.D., M.D., Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03294382    
Other Study ID Numbers: 9hospital
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Ru-Lin Huang, Shanghai Jiao Tong University School of Medicine:
epicanthoplasty
Botulinum Toxins
scar
intercanthal distance
blepharoplasty
Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents