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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04157686
Study type Interventional
Source Medy-Tox
Contact
Status Completed
Phase Phase 3
Start date October 23, 2019
Completion date February 16, 2023

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