Duration of Botox Using OLD Versus COLD for Treatment of Glabellar Lines

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Clinical Testing of Beverly Hills
Updated on 3 October 2022
Accepts healthy volunteers

Summary

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

Description

This study involves a blinded, randomized, parallel-group design. The aim of this study is to evaluate the duration response of BOTOX 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 BOTOX 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.

Details
Condition Glabellar Frown Lines
Treatment OnabotulinumtoxinA
Clinical Study IdentifierNCT05083286
SponsorClinical Testing of Beverly Hills
Last Modified on3 October 2022

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