Botulinum Toxin to Improve Lower Blepharoplasty Scar
- Conditions
- Other Degenerative Disorders of Eyelid and Periocular Area
- Interventions
- Other: Normal Saline
- Registration Number
- NCT02786550
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- Adult ≥ 45 years old.
- Lower eyelid Rhytidosis and dermatochalasis.
- Lower eyelid steatoblepharon and pronounced nasojugal groove
- Written informed consent given by patient.
- Less than 45 years old
- Without written informed consent.
- Combined other craniofacial anomalies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Botulinum Toxin 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 Normal saline 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
- Primary Outcome Measures
Name Time Method Visual analogue scale 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
Name Time Method Photographic measurement 6 months after surgery A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured
Vancouver scar scale 6 months after surgery Use vancouver scar scale to access the scar of blepharoplasty
Trial Locations
- Locations (1)
Chun-Chin Chang
🇨🇳Taoyuan, Taiwan