Botulinum Toxin to Improve Lower Blepharoplasty Scar

Other Degenerative Disorders of Eyelid and Periocular Area Clinical Trial

Official title:

Botulinum Toxin to Improve Lower Blepharoplasty Scar

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02786550
• Other study ID #: 104-8788A3
• Status: Recruiting
• Phase: Phase 4
• First received: May 26, 2016
• Last updated: June 22, 2016
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: May 2016
• Source: Chang Gung Memorial Hospital
• Contact: Chun Shin Chang, M.S.
• Phone: +886975365538
• Email: frankchang[@]cgmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Eyelid Diseases
• Other Degenerative Disorders of Eyelid and Periocular Area

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chun-Chin Chang	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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):511-6. doi: 10.1097/PRS.0000000000000416. — View 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. — View 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. — View 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. Review. — View 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. 2015 Sep 28. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Vancouver scar scale	Use vancouver scar scale to access the scar of blepharoplasty	6 months after surgery	No
Secondary	Photographic measurement	A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured	6 months after surgery	No