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

Early Phase 1

Active, not recruiting

• Conditions: Glabellar Frown Lines
• Interventions: Drug: Onabotulinum toxin A; Drug: PrabotulinumtoxinA

• Registration Number: NCT04715048
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-10
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-14
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Onabotulinumtoxin A	Onabotulinum toxin A	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.
Prabotulinumtoxin A	PrabotulinumtoxinA	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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.
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).

Trial Locations

Locations (1)

USC Roski Eye Institute; 🇺🇸 Los Angeles, California, United States