Botulinum Toxin to Improve Lower Blepharoplasty Scar

NCT02786550 | Unknown Phase 4 DMC

• 1 other identifier: 104-8788A3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Degenerative Disorders of Eyelid and Periocular Area

Keywords

Lower blepharoplasty, Botulinum toxin, Scar

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months after surgery

Secondary Outcomes (2)

• Vancouver scar scale

  6 months after surgery

• Photographic measurement

  6 months after surgery

Study Arms (2)

Botulinum Toxin

EXPERIMENTAL

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

Normal saline

PLACEBO COMPARATOR

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

Interventions

Botulinum Toxin DRUG

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).

Also known as: Botulinum Toxin Type A, Botox

Botulinum Toxin

Normal Saline OTHER

The same amount (3 cc) of Normal saline will be injected to the lateral part of obicularis oculis muscle

Also known as: Na Cl 0.9%

Normal saline

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Less than 45 years old
• Without written informed consent.
• Combined other craniofacial anomalies

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chun-Chin Chang

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (6)

• 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.

  PMID: 25541942 BACKGROUND

• 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.

  PMID: 25158709 BACKGROUND

• 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.

  PMID: 26985661 BACKGROUND

• 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.

  PMID: 26719648 BACKGROUND

• 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.

  PMID: 26665143 BACKGROUND

• 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.

  PMID: 26418784 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Interventions

Botulinum Toxins; Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Henry Yau-Li Huang, M.D.

  Department of Dermatology, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Shin Chang, M.S.

CONTACT

+886975365538; frankchang@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 1, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 23, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)