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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Drug: Onabotulinum toxin A; Drug: PrabotulinumtoxinA

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Sandy Zhang-Nunes, MD; Phone Number: (800) 872-2273; Email: zhangnun@usc.edu
• Study Contact Backup: Name: Preeya Mehta; Phone Number: (408) 3344842; Email: preeyame@usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Roski Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Onabotulinumtoxin 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.	Drug: Onabotulinum toxin A; Glabellar line correction; Other Names: Botox
Experimental: Prabotulinumtoxin A; 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; Glabellar line correction; Other Names: Jeuveau

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern California

Publications and helpful links

General Publications

• Rzany BJ, Ascher B, Avelar RL, Bergdahl J, Bertucci V, Bodokh I, Carruthers JA, Cartier H, Delmar H, Denfeld R, Gross JE, Heckmann M, Heden P, Hilton S, Inglefield C, Ogilvie P, Sattler G, Sebastian M, Solish N, Swift A, Trevidic P. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients. Aesthet Surg J. 2020 Mar 23;40(4):413-429. doi: 10.1093/asj/sjz110.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 10, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Botox, Jeuveau
• Other Study ID Numbers: HS-19-00455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes