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

NCT05320393 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-09-04

Study results available
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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

Interventions

DRUG

PrabotulinumtoxinA-Xvfs

One treatment of 40 units

DRUG

OnabotulinumtoxinA

One treatment of 20 units

DRUG

PrabotulinumtoxinA-Xvfs

One treatment of 20 units

Sponsors & Collaborators

  • ethica Clinical Research Inc.

    collaborator INDUSTRY

  • Evolus, Inc.

    lead INDUSTRY

Principal Investigators

  • Rui Avelar, MD · Evolus, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2023-05-22
Completion
2023-05-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05320393 on ClinicalTrials.gov