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Botulinum Toxin to Improve Lower Blepharoplasty Scar

Primary Purpose

Other Degenerative Disorders of Eyelid and Periocular Area

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Botulinum Toxin
Normal Saline
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Other Degenerative Disorders of Eyelid and Periocular Area focused on measuring Lower blepharoplasty, Botulinum toxin, Scar

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chun-Chin ChangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botulinum Toxin

Normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual analogue scale
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

Vancouver scar scale
Use vancouver scar scale to access the scar of blepharoplasty
Photographic measurement
A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured

Full Information

First Posted
May 26, 2016
Last Updated
June 22, 2016
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02786550
Brief Title
Botulinum Toxin to Improve Lower Blepharoplasty Scar
Official Title
Botulinum Toxin to Improve Lower Blepharoplasty Scar
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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:- Study group (Group I): Immediately after lower blepharoplasty surgery 3 injections of 2.5U of botulinum toxin over lateral part of orbicularis oculi muscle. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Degenerative Disorders of Eyelid and Periocular Area
Keywords
Lower blepharoplasty, Botulinum toxin, Scar

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Botulinum Toxin
Arm Type
Experimental
Arm Description
Immediately after lower blepharoplasty surgery 3 injections of 2.5U of botulinum toxin over lateral part of orbicularis oculi muscle. Intervention: Botulinum toxin injection
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Immediately after lower blepharoplasty surgery 3 injections of same amount of normal saline over lateral part of orbicularis oculi muscle. Intervention: Normal saline injection
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin
Other Intervention Name(s)
Botulinum Toxin Type A, Botox
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Na Cl 0.9%
Intervention Description
The same amount (3 cc) of Normal saline will be injected to the lateral part of obicularis oculis muscle
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
to score the scars on the photographs using a standard visual analogue scale graded from 0 (worst possible scar) to 10 (best possible scar).
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Vancouver scar scale
Description
Use vancouver scar scale to access the scar of blepharoplasty
Time Frame
6 months after surgery
Title
Photographic measurement
Description
A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult ≥ 45 years old. Lower eyelid Rhytidosis and dermatochalasis. Lower eyelid steatoblepharon and pronounced nasojugal groove Written informed consent given by patient. Exclusion Criteria: Less than 45 years old Without written informed consent. Combined other craniofacial anomalies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun Shin Chang, M.S.
Phone
+886975365538
Email
frankchang@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Yau-Li Huang, M.D.
Organizational Affiliation
Department of Dermatology, Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chun-Chin Chang
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Shin Chang, M.D., M.S.
Phone
+88633281200
Ext
2430
Email
frankchang@cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25541942
Citation
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.
Results Reference
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PubMed Identifier
25158709
Citation
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.
Results Reference
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PubMed Identifier
26985661
Citation
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.
Results Reference
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PubMed Identifier
26719648
Citation
Lee SJ, Jeong SY, No YA, Park KY, Kim BJ. Combined Treatment with Botulinum Toxin and 595-nm Pulsed Dye Laser for Traumatic Scarring. Ann Dermatol. 2015 Dec;27(6):756-8. doi: 10.5021/ad.2015.27.6.756. Epub 2015 Dec 7.
Results Reference
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PubMed Identifier
26665143
Citation
Prodromidou A, Frountzas M, Vlachos DE, Vlachos GD, Bakoyiannis I, Perrea D, Pergialiotis V. Botulinum toxin for the prevention and healing of wound scars: A systematic review of the literature. Plast Surg (Oakv). 2015 Winter;23(4):260-4. doi: 10.4172/plastic-surgery.1000934.
Results Reference
background
PubMed Identifier
26418784
Citation
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.
Results Reference
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Botulinum Toxin to Improve Lower Blepharoplasty Scar

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