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

Early Phase 1UnknownNCT04715048

University of Southern California20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Glabellar Frown Lines

Interventions

PrabotulinumtoxinADRUG

Glabellar line correction

Onabotulinum toxin ADRUG

Glabellar line correction

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

USC Roski Eye Institute

Los Angeles, California, United States

Outcomes

Primary Outcomes

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).

Time frame: 3 weeks

Secondary Outcomes

Days to onset of neurotoxin

\# of days until neurotoxin begins decreasing movement on each side

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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