Botulinum Toxin to Improve Lower Blepharoplasty Scar

Study Overview
=================
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.

Official Title
-----------------
Botulinum Toxin to Improve Lower Blepharoplasty Scar

Conditions
-----------------
Other Degenerative Disorders of Eyelid and Periocular Area

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin
* Other: Normal Saline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum Toxin<br>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<br>* 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).<br>* Other names: Botox;|
| Placebo Comparator: Normal saline<br>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<br>* The same amount (3 cc) of Normal saline will be injected to the lateral part of obicularis oculis muscle<br>* Other names: Na Cl 0.9%;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancouver scar scale | Use vancouver scar scale to access the scar of blepharoplasty | 6 months after surgery | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lower blepharoplasty, Botulinum toxin, Scar