Study to Demonstrate Safety and Duration of Effect of 40 Units of PrabotulinumtoxinA-xvfs to Treat Glabellar Lines

NCT05320393 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EVOLUS-CLIN201
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate the safety and duration of effect of 40 Units of prabotulinumtoxinA-xvfs (Jeuveau®) in providing temporary improvement in the appearance of moderate to severe glabellar lines (frown lines, which are the vertical lines that develop between the eyebrows) in adult participants. It will also determine if the duration of effect of 40 Units of Jeuveau® is greater than that of 20 Units of Jeuveau® and 20 Units of Botox® Cosmetic.

Conditions

Glabellar Frown Lines

Keywords

Botulinum toxin type A

Outcome Measures

Primary Outcomes (1)

• Duration of Effect Described by Kaplan-Meier Analysis

  Effectiveness of prabotulinumtoxinA 40 Units compared to prabotulinumtoxinA 20 Units will be assessed for each subject based on the number of days from baseline to the day that the Glabellar Line Scale (GLS) severity, by Investigator Assessment, returns to the baseline value. The treatment will be considered to remain effective for the amount of time during which the GLS severity at maximum frown has not returned to baseline severity.

  Duration of effect for each subject will be based on number of days from baseline to the day that Glabellar Line Scale severity (Investigator Assessment) returns to baseline value, assessed every 30 days up to 365 days.

Study Arms (3)

Study Drug

EXPERIMENTAL

40U of PrabotulinumtoxinA-xvfs

Drug: PrabotulinumtoxinA-Xvfs

OnabotulinumtoxinA

ACTIVE COMPARATOR

20U of OnabotulinumtoxinA

Drug: OnabotulinumtoxinA

PrabotulinumtoxinA-xvfs

ACTIVE COMPARATOR

20U of PrabotulinumtoxinA-xvfs

Drug: PrabotulinumtoxinA-Xvfs

Interventions

PrabotulinumtoxinA-Xvfs DRUG

One treatment of 40 units

Also known as: Jeuveau

Study Drug

OnabotulinumtoxinA DRUG

One treatment of 20 units

Also known as: Botox Cosmetic

OnabotulinumtoxinA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient, male or female of any race, 18 years of age or older.
• Female subjects of childbearing potential must have a negative urine pregnancy test during Visits 1 (Screening) and Visit 2 (if applicable) and practice a reliable method of contraception for the duration of the study.
• Moderate to severe glabellar lines (i.e., score of 2 or 3) on maximum frown as assessed by the investigator using the Glabellar Line Scale (GLS).
• Subject has moderate to severe glabellar lines (i.e., score of 2 or 3) at maximum frown as assessed by the subject using the GLS.
• Able to follow study instructions and likely to complete all required visits.
• Sign the Institutional Review Board (IRB) -approved Informed Consent Form (ICF) prior to any study-related procedures being performed.

You may not qualify if:

• Female subjects who are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
• Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Product (IP) or control.
• Any active infection in the area of the injection sites.
• Inability to substantially lessen glabellar frown lines even by physically spreading them apart.
• Marked facial asymmetry (Investigator discretion).
• Ptosis of eyelid and/or eyebrow, or history of eyelid and/or eyebrow ptosis.
• History of facial nerve palsy.
• Excessive dermatochalasis, deep dermal scarring, thick sebaceous skin (Investigator discretion).
• Medical condition that may affect neuromuscular function (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis).
• Previous treatment with botulinum toxin of any serotype above the level of the lateral canthus within the last 6 months.
• Planned treatment with botulinum toxin of any serotype below the level of the lateral canthus during the study period.
• Previous treatment with any facial aesthetic procedure (e.g., injection with biodegradable fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 months.
• Previous insertion of permanent material in the glabellar area.
• Any previous energy based or cryotherapy-based treatment of facial muscles superior to the lateral canthus.
• Any other planned facial aesthetic procedure during the trial period, superior to the level of the lateral canthus (can continue with their usual skin care routine).

Sponsors & Collaborators

• Evolus, Inc.: lead
• ethica Clinical Research Inc.: collaborator

Study Sites (1)

Aesthetic Eyelid Plastic Surgery

Boca Raton, Florida, 33431, United States

Location

MeSH Terms

Interventions

prabotulinumtoxin A; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Rui Avelar
• Organization: Evolus, Inc.

rui.avelar@evolus.com

1-949-284-4689

Study Officials

• Rui Avelar, MD

  Evolus, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 11, 2022
• Study Start: March 30, 2022
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: September 4, 2024
• Results First Posted: September 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)