Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT05305768
Brief Summary:
This is a blinded, randomized study in the US to compare the duration response of two different concentrations of Xeomin in healthy female subjects with moderate to severe dynamic glabellar lines on maximum frown.
Detailed Description:
This study involves a blinded, randomized, parallel-group design. The aim of this study is to evaluate the duration response of Xeomin 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 0.05 mL and the OLD concentration is defined as 4 Units per 0.1 mL.
The total Xeomin 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 0.05 mL) group will receive a total of 0.25mL.
Study:
NCT05305768
Study Brief:
Protocol Section:
NCT05305768