Glabellar Frown Lines
Conditions
Keywords
Botox, Jeuveau
Brief summary
The purpose of this study is to compare the efficacy and side effects of Botox and Jeuveau for glabellar lines.
Detailed description
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.
Interventions
Glabellar line correction
Glabellar line correction
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The two different neurotoxins will be drawn into identical appearing syringes by an unblinded investigator. The injector will be a blinded investigator and will not know which syringe has which neurotoxin. There is no difference in appearance of the product when in a standardized syringe. The PI and co-investigator will be graders of these images and will be blinded during the grading process.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Movement on a 10 point Frown Movement Scale at 3 weeks | 3 weeks | 10-point scale created by the investigator assessing movement of glabellar lines. Possible scores range from 0 (no movement) to 10 (movement). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bruising from the injection on a scale of 1-10 | Up to 2-4 days | Post injection bruising measured on a scale from 0 (no bruising) to 10 (most possible bruising) created by the investigator. |
| Pain from the injection on a scale of 1-10 | Up to 2-4 days | Post injection pain will be measured on a scale from 0 (no pain) to 10 (most possible pain) created by the investigator. |
| Days to onset of neurotoxin | Up to 2-4 days | \# of days until neurotoxin begins decreasing movement on each side |
| Movement on a 10 point Frown Movement Scale at 3 weeks | 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). |
| Change in glabellar lines on the Merz Score (0-4) | At baseline and 3 weeks | 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. |
| Headache from the injection on a scale of 1-10 | Up to 2-4 days | Post injection headache will be measured on a scale from 0 (no pain) to 10 (most possible pain) created by the investigator. |
Countries
United States
Outcome results
None listed