Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT05305768
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2021-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Xeomin Treatment of Glabellar Lines Using OLD Versus COLD
Sponsor:
Clinical Testing of Beverly Hills
Organization:
Study Overview
Official Title:
A Randomized, Parallel-Group Study on the Duration Response of Highly Concentrated On Label Dose (COLD) of Xeomin® Compared to the On Label Dose and Concentration (OLD) in Subjects With Moderate to Severe Dynamic Glabellar Lines
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: