Split-Face Prospective Study Comparing Botox to Xeomin for the Treatment of Facial Wrinkles

Study Overview
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Brief Summary
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The aim of this prospective, randomized, double-blind, intraindividual split face study will be to compare onabotulinumtoxinA to incobotulinumtoxinA for the correction of facial wrinkles using a 1:1 dose ratio.

Detailed Description
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Patients will be randomized to which side of the face will be injected with onabotulinumtoxinA and incobotulinumtoxinA. A total dose of 22.5 units of onabotulinumtoxinA and 22.5 units of incobotulinumtoxinA will be administered at baseline to the respected side of the face. One vial (100 MU) of BoNTA will be reconstituted with 2.0 mL of 0.9% sterile saline solution. Similarly, one vial (100 MU) of BTXCo will be reconstituted with 2.0 mL of 0.9% sterile saline solution. 2.5 units of the respective neurotoxin will be administered to three sites in the crow's feet area on each side (7.5 units total for one side), 2.5 units to two locations of the forehead on each side (5 units total for one side), and 5.0 units to two locations in the glabella on each side(10 units total for one side). The duration of the study will be 4 months. The followup visits after the initial injections will be at 3 days, 2 weeks, 3 months, and 4 months after the initial treatment. At each of these visits, standardized digital photographs of the treated facial area will be taken. Both static and dynamic photos will be taken of each region. At the conclusion of the study, three independent raters will individually perform blind assessments of the photographs according to the Validated Assessment Scaled for the Upper Face published by Flynn et al 2012.

Official Title
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Split-Face, Double-blind, Single Center, Prospective Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA

Conditions
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Facial Wrinkles

Intervention / Treatment
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* Drug: Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects
* Drug: Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males and females age 18 or older. Exclusion Criteria: Previous treatment with a neuromodulator in the last 6 months previous brow lift currently pregnant or breastfeeding a history of neurological disease or deficit an active facial skin infection an allergy to neuromodulators

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Xeomin right side; Xeomin to left side of face<br>Patients were randomized as to which side of the face was treated with Xeomin. | Drug: Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects<br>* Subjects were randomized to which side of the face would be treated with Xeomin.<br>* Other names: incobotulinumtoxinA (Xeomin);|
| Active Comparator: Botox right side; Botox to left side<br>Patients were randomized as to which side of the face was treated with Botox. | Drug: Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects<br>* Subjects were randomized to which side of the upper face would be treated with Botox<br>* Other names: onabotulinumtoxinA (Botox);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wrinkles Score | Objective assessment of change in wrinkles score pre and post injection of the crow's feet, glabella, and forehead using the Validated Assessment Scaled for the Upper Face published by Flynn et al. 2012. At the end of the study the delta wrinkle score from pre-injection to each followup assessment for each area will be calculated. | Preinjection assessment; assessment at 3 days, 2 weeks, 3 months, 4 months post-injection |