NCT04157686

MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)

A Multicenter, Long-term, Open-label Study to Evaluate the Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines and Lateral Canthal Lines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 957 (actual)
• Sponsor: Medy-Tox · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.

Detailed description

Study MT10109L-004 is an open-label extension involving participants from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006 (NCT03732833) (referred to as Lead-In studies). The objective is to evaluate long term safety of MT10109L. Participants will include those who completed the global lead-in studies and meet the eligibility criteria for entering this open-label extension study. Participants who meet retreatment criteria will receive MT10109L administered in the same treatment area(s) with the same number of injections and injection sites as in their lead-in studies. The safety and efficacy data from the lead-in and this open-label extension will be summarized.

Conditions

• Glabellar Lines
• Lateral Canthal Lines

Interventions

Type	Name	Description
DRUG	MT10109L Dose 1	MT10109L Dose 1 will be injected into the GL area
DRUG	MT10109L Dose 2	MT10109L Dose 2 will be injected into the LCL area
DRUG	MT10109L Dose 1 + Dose 2	MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area

Timeline

• Start date: 2019-10-23
• Primary completion: 2023-02-16
• Completion: 2023-02-16
• First posted: 2019-11-08
• Last updated: 2024-08-09
• Results posted: 2024-08-09

Locations

38 sites across 6 countries: United States, Belgium, Canada, Germany, Russia, United Kingdom

Regulatory

• FDA-regulated drug study