CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 154 enrolled
Drug / intervention
PrabotulinumtoxinA-Xvfs +2 moredrug
Likely dose
PrabotulinumtoxinA-Xvfs 40 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05320393
NCT05320393Phase 2Completed
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Phase II Multi-Ctr, Prospective, Randomized, Double Blind, Active-Controlled Single Treatment Increasing Dose Trial to Study Safety & Duration of Effect of 40U of PrabotulinumtoxinA-xvfs in Adult Subjects for Treatment of Glabellar Lines

Evolus, Inc.·interventional·Posted Apr 11, 2022·Updated Sep 4, 2024

In Brief

A Phase 2 clinical trial evaluating PrabotulinumtoxinA-Xvfs and OnabotulinumtoxinA for Glabellar Frown Lines. Completed, enrolled 154 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlabellar Frown Lines
CountriesUnited States
Collaboratorsethica Clinical Research Inc.

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedApr 11, 2022
Enrollment StartMar 30, 2022
Primary CompletionMay 22, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.2 years ago

Interventions

PrabotulinumtoxinA-Xvfsdrug

One treatment of 40 units

OnabotulinumtoxinAdrug

One treatment of 20 units

PrabotulinumtoxinA-Xvfsdrug

One treatment of 20 units