Split-Face Study Comparing Botox and Jeuveau in Treating Glabellar Lines

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and side effects of Botox and Jeuveau for glabellar lines.

Detailed Description
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After being informed about the study and potential risks, all patients given consent will receive Botox on one side of their face and Jueveau on the other. A random number generator will generate a list of 20 combinations of 1,2 or 2,1. 1,2 means the Botox (onabotulinumtoxin A) will be placed on the right side and 2,1 means that the Botox will be placed on the left. The other side will be injected with PrabotulinumtoxinA. 8-10 units will be injected into the designated glabella in 3 sites.

Official Title
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Split-Face Study Comparing OnabotulinumtoxinA (Botox) and PrabotulinumtoxinA (Jeuveau) in Treating Glabellar Lines

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Drug: PrabotulinumtoxinA
* Drug: Onabotulinum toxin A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 Willingness to participate in the study and able to provide informed consent Exclusion Criteria: Inability to follow up for study duration Prior neurotoxin injection in the last 4 months Prior surgery to the glabellar area Any planned aesthetic procedure to the glabellar area during the study period Cardiac Patients

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Onabotulinumtoxin A<br>8-10 units of Botox will be injected in the glabellar lines in one side of the face in 3 different locations. This injection will happen once. | Drug: Onabotulinum toxin A<br>* Glabellar line correction<br>* Other names: Botox;|
| Experimental: Prabotulinumtoxin A<br>8-10 units of Jeuveau will be injected in the glabellar lines in the other side of the face in 3 different locations. This injection will happen once. | Drug: PrabotulinumtoxinA<br>* Glabellar line correction<br>* Other names: Jeuveau;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement on a 10 point Frown Movement Scale at 3 weeks | 10-point scale created by the investigator assessing movement of glabellar lines. Possible scores range from 0 (no movement) to 10 (movement). | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to onset of neurotoxin | # of days until neurotoxin begins decreasing movement on each side | Up to 2-4 days | 
| Bruising from the injection on a scale of 1-10 | Post injection bruising measured on a scale from 0 (no bruising) to 10 (most possible bruising) created by the investigator. | Up to 2-4 days | 
| Pain from the injection on a scale of 1-10 | Post injection pain will be measured on a scale from 0 (no pain) to 10 (most possible pain) created by the investigator. | Up to 2-4 days | 
| Headache from the injection on a scale of 1-10 | Post injection headache will be measured on a scale from 0 (no pain) to 10 (most possible pain) created by the investigator. | Up to 2-4 days | 
| Movement on a 10 point Frown Movement Scale at 3 weeks | Patients grade their own movement of glabellar lines using a 10-point scale created by the investigator. Possible scores range from 0 (no movement) to 10 (movement). | 3 weeks | 
| Change in glabellar lines on the Merz Score (0-4) | The Merz Score is a 5 point scale. The Merz Score will be used to grade glabellar lines at rest and frown at both baseline and the 3 week visit. Change will calculated from the 3 week visit compared to baseline. | At baseline and 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botox, Jeuveau