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Clinical Trial Summary

This is a blinded, randomized study in the US to compare the duration response of two different concentrations of Jeuveau in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown.


Clinical Trial Description

This study involves a blinded, randomized, parallel-group design. The aim of this study is to evaluate the duration response of Jeuveau in subjects with moderate to severe dynamic glabellar lines at the approved on-label dose of 20 U, however comparing the use of highly Concentrated On Label Dose (COLD) to the On Label Dose and concentration (OLD). The COLD concentration is defined as 4 Units per 0.02 mL and the OLD concentration is defined as 4 Units per 0.1 mL. The total Jeuveau dose will be 20U divided into 5 injections for both study groups. However, the injection volume will differ for the two study groups, such that the OLD (4 U per 0.1 mL) group will receive a total of 0.5 mL and the COLD (4 U per 0.02 mL) group will receive a total of 0.1mL. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05129319
Study type Interventional
Source Clinical Testing of Beverly Hills
Contact
Status Completed
Phase Early Phase 1
Start date December 16, 2021
Completion date June 15, 2023

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