NCT05305768

Xeomin Treatment of Glabellar Lines Using OLD Versus COLD

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
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Clinical Testing of Beverly Hills · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Glabellar Frown Lines

Interventions

Type	Name	Description
DRUG	IncobotulinumtoxinA	Injection of glabellar rhytids

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2022-03-31
• Last updated: 2022-03-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study