Botulinum Toxin to Improve Lower Blepharoplasty Scar
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|ClinicalTrials.gov Identifier: NCT02786550|
Recruitment Status : Unknown
Verified May 2016 by Chang Gung Memorial Hospital.
Recruitment status was: Recruiting
First Posted : June 1, 2016
Last Update Posted : June 23, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Other Degenerative Disorders of Eyelid and Periocular Area||Drug: Botulinum Toxin Other: Normal Saline||Phase 4|
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Botulinum Toxin to Improve Lower Blepharoplasty Scar|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: 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
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).
Placebo Comparator: 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
Other: Normal Saline
The same amount (3 cc) of Normal saline will be injected to the lateral part of obicularis oculis muscle
Other Name: Na Cl 0.9%
- Visual analogue scale [ Time Frame: 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).
- Vancouver scar scale [ Time Frame: 6 months after surgery ]Use vancouver scar scale to access the scar of blepharoplasty
- Photographic measurement [ Time Frame: 6 months after surgery ]A ruler will be placed just below the surgical scar. Using Photoshop CS5, the scar width can be measured
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786550
|Contact: Chun Shin Chang, M.S.||+firstname.lastname@example.org|
|Taoyuan, Taiwan, 333|
|Contact: Chun Shin Chang, M.D., M.S. +88633281200 ext 2430 email@example.com|
|Principal Investigator:||Henry Yau-Li Huang, M.D.||Department of Dermatology, Chang Gung Memorial Hospital|