CompletedPhase 3

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

United States957 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 range19 Years

SexALL

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.

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 range19 Years

SexALL

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