CompletedPhase 3

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

United States, Belgium, Canada957 participantsStarted 2019-10-23

Plain-language 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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Completion of lead-in Phase 3 study; * Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Exclusion Criteria: * Known immunization or hypersensitivity to any botulinum toxin serotype; * Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function; * Known allergy or sensitivity to any of the components of the study interventions, or any materials used in the study procedures; * Females who are pregnant, nursing, or planning a pregnancy during the study; * Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Who Experienced Any Adverse Event (AE)

Timeframe: Baseline to Day 720 or Study Exit

Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)

Timeframe: Baseline to Day 720 or Study exit

Mean Change From Baseline in Pulse Rate (Beats Per Minute)

Timeframe: Baseline to Day 720 or Study Exit

Mean Change From Baseline in Systolic Blood Pressure (mm Hg)

Timeframe: Baseline to Day 720 or Study Exit

Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)

Timeframe: Baseline to Day 720 or Study Exit

Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)

Timeframe: Baseline to Day 720 or Study Exit

Number of Participants With Binding and Neutralizing Antibodies

Timeframe: Baseline to Day 720 or Study Exit

Trial details

NCT IDNCT04157686

SponsorMedy-Tox

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-16

Results submitted2024-07-04

View on ClinicalTrials.gov More Glabellar Lines trials

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants Who Experienced Any Adverse Event (AE)

Timeframe: Baseline to Day 720 or Study Exit

Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)

Timeframe: Baseline to Day 720 or Study exit

Mean Change From Baseline in Pulse Rate (Beats Per Minute)

Timeframe: Baseline to Day 720 or Study Exit

Mean Change From Baseline in Systolic Blood Pressure (mm Hg)

Timeframe: Baseline to Day 720 or Study Exit

Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)

Timeframe: Baseline to Day 720 or Study Exit

Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)

Timeframe: Baseline to Day 720 or Study Exit

Number of Participants With Binding and Neutralizing Antibodies

Timeframe: Baseline to Day 720 or Study Exit