Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Botulinum Toxin to Improve Lower Blepharoplasty Scar

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: NCT02786550
Recruitment Status : Unknown
Verified May 2016 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : June 1, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:

The combination of Botulinum toxin for crow feet (lateral part of orbicularis oculi muscle) and lower blaphaloplasty might have reduces the tension on the end of lower blaphaloplasty incision whereas the scar is more visible on patient.

The main aim of this trial is to investigate whether the injection of Botulinum toxin into the bilateral orbicularis oculi muscles could improve the appearance of the scar after lower blepharoplasty.


Condition or disease Intervention/treatment Phase
Other Degenerative Disorders of Eyelid and Periocular Area Drug: Botulinum Toxin Other: Normal Saline Phase 4

Detailed Description:

The main aim of this double blind randomized trial is to examine whether immediate post-operative injection of botulinum toxin into lateral part of bilateral orbicularis oculis muscles (the injection technique of crow feet) can improve scar formation for lower blepharoplasty patients.

This is a double blind randomized controlled trial primarily designed to compare the scarring after secondary cleft lip repair with immediate post-operative botulinum toxin injection into the into bilateral lateral orbicularis oculi muscles in patients with lower blepharoplasty. There will be 2 main groups in this study:-

  1. Study group (Group I): Immediately after lower blepharoplasty surgery 3 injections of 2.5U of botulinum toxin over lateral part of orbicularis oculi muscle.
  2. Control group (Group II): There will be the same amount of normal saline injection after lower blepharoplasty.

Follow-up Assessments Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month Follow Up.

Visual analogue scale They were asked to score the scars on the photographs using a standard visual analogue scale graded from 0 (worst possible scar) to 10 (best possible scar).

Photographic measurement:

A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured.

Chi-square will be used to analyze the demographic data ( i.e. Gender) The Independent T-Student test will be used to analyze the statistical significance between the two groups.

The dosage of Botox that the investigators use for crowfeet is very tiny. And this is a common clinic practice. Systemic insult is unlikely to happen. If an allergic reaction occurred it will be treated according to the severity of allergy and Diphenhydramin PO or IV form or systemic corticosteroid will be given.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Botulinum Toxin to Improve Lower Blepharoplasty Scar
Study Start Date : June 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: Botulinum Toxin

Immediately after lower blepharoplasty surgery 3 injections of 2.5U of botulinum toxin over lateral part of orbicularis oculi muscle.

Intervention: Botulinum toxin injection

Drug: Botulinum Toxin
A total of 7.5U per side of botulinum toxin will be injected to the lateral part of obicularis oculis muscle (3 injections of 2.5 U).
Other Names:
  • Botulinum Toxin Type A
  • Botox

Placebo Comparator: Normal saline

Immediately after lower blepharoplasty surgery 3 injections of same amount of normal saline over lateral part of orbicularis oculi muscle.

Intervention: Normal saline injection

Other: Normal Saline
The same amount (3 cc) of Normal saline will be injected to the lateral part of obicularis oculis muscle
Other Name: Na Cl 0.9%




Primary Outcome Measures :
  1. Visual analogue scale [ Time Frame: 6 months after surgery ]
    to score the scars on the photographs using a standard visual analogue scale graded from 0 (worst possible scar) to 10 (best possible scar).


Secondary Outcome Measures :
  1. Vancouver scar scale [ Time Frame: 6 months after surgery ]
    Use vancouver scar scale to access the scar of blepharoplasty

  2. Photographic measurement [ Time Frame: 6 months after surgery ]
    A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult ≥ 45 years old.
  2. Lower eyelid Rhytidosis and dermatochalasis.
  3. Lower eyelid steatoblepharon and pronounced nasojugal groove
  4. Written informed consent given by patient.

Exclusion Criteria:

  1. Less than 45 years old
  2. Without written informed consent.
  3. Combined other craniofacial anomalies

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): NCT02786550


Contacts
Layout table for location contacts
Contact: Chun Shin Chang, M.S. +886975365538 frankchang@cgmh.org.tw

Locations
Layout table for location information
Taiwan
Chun-Chin Chang Recruiting
Taoyuan, Taiwan, 333
Contact: Chun Shin Chang, M.D., M.S.    +88633281200 ext 2430    frankchang@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Layout table for investigator information
Principal Investigator: Henry Yau-Li Huang, M.D. Department of Dermatology, Chang Gung Memorial Hospital

Publications:
Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02786550    
Other Study ID Numbers: 104-8788A3
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chang Gung Memorial Hospital:
Lower blepharoplasty, Botulinum toxin, Scar
Additional relevant MeSH terms:
Layout table for MeSH terms
Eyelid Diseases
Eye Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs