Glabellar Lines, Lateral Canthal Lines
Conditions
Brief summary
To evaluate the safety and efficacy of MT10109L for the treatment of lateral canthal lines (LCL) with or without concurrent treatment of glabellar lines (GL) in participants with moderate to severe LCL and GL.
Interventions
DRUGMT10109L
MT10109L will be injected into either the LCL, or both the LCL and GL.
DRUGPlacebo
Placebo will be injected into either the GL, or both the LCL and GL.
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-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. * History of facial nerve palsy. * Any uncontrolled systemic disease. * Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention). * Anticipated need for surgery or overnight hospitalization during the study. * Prior exposure to botulinum toxin of any serotype for any reason. * Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid \[blepharoplasty\] and/or eyebrow surgery). * Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation. * Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 30 | Day 30 | The outcome measured is the percentage of participants who had a ≥2-grade improvement from baseline LCL severity at maximum smile according to investigator and participant FWS ratings at Day 30. Both the INVESTIGATOR AND PARTICIPANT evaluate the LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the FWS | Day 1 (first treatment) to Day 180 | The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. |
| The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL) | Day 60 | The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied. |
| The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS) | Day 30 | The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. Among Participants Who Were Rated At least Mild at Rest at Baseline, where a Responder was Defined as Achieving a ≥1-grade Improvement from Baseline at Day 30. The outcome measured here is the proportion of participants who achieved a ≥1-grade improvement from baseline LCL severity at rest based on investigator FWS rating. |
| Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs) | AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose. | This section focuses primarily on TEAEs, i.e., AEs that started or worsened after the first dose of study intervention and within 30 days after the last dose. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs. |
| Mean Change From Baseline in Systolic Blood Pressure (BP) | Baseline to Day 360 | The outcome reported here is the mean change in Systolic BP from baseline to study exit. |
| Mean Change From Baseline in Diastolic Blood Pressure (BP) | Baseline to Day 360 | The outcome reported here is the mean change in Diastolic BP from baseline to study exit. |
| Mean Change From Baseline in Pulse Rate | Baseline to Day 360 | The outcome reported here is the mean change in Pulse Rate from baseline to study exit. |
| Mean Change From Baseline in Respiratory Rate | Baseline to Day 360 | The outcome reported here is the mean change in Respiratory Rate from baseline to study exit. |
| The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS) | Day 30 | The outcome here only considers the INVESTIGATOR assessments (excludes the participant assessment). The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. A Responder was defined as one achieving a ≥2-grade improvement from baseline at maximum smile at Day 30. |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval | Baseline to Day 360 | The outcome reported here is a mean change in PR interval from baseline to study exit. |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration | Baseline to Day 360 | The outcome reported here is a mean change in QRS duration from baseline to study exit. |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval | Baseline to Day 360 | The outcome reported here is a mean change in QT interval from baseline to study exit. |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval | Baseline to Day 360 | The outcome reported here is a mean change in QTcB interval from baseline to study exit. |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval | Baseline to Day 360 | The outcome reported here is a mean change in QTcF interval from baseline to study exit. |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval | Baseline to Day 360 | The outcome reported here is a mean change in RR interval from baseline to study exit. |
| Number of Participants With Binding and Neutralizing Antibodies | Baseline to Day 360 | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate | Baseline to Day 360 | The outcome reported here is a mean change in mean heart rate from baseline to study exit. |
Countries
Canada, Germany, United States
Participant flow
Pre-assignment details
Overall, 602 participants were screened, 424 participants were analyzed in ITT set and 425 participants were analyzed in Safety set.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo was injected into the Lateral Canthal Lines (LCL) and into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. | 86 |
| MT10109L 24U + Placebo MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and Placebo into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
. | 171 |
| MT10109L 24U + MT10109L 20U MT10109L 24U was injected into the Lateral Canthal Lines (LCL) and MT10109L 20U into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. | 167 |
| Total | 424 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 | 1 |
| Overall Study | Covid-19 related and other reasons | 2 | 7 | 3 |
| Overall Study | Lost to Follow-up | 3 | 5 | 4 |
| Overall Study | Physician Decision | 2 | 3 | 1 |
| Overall Study | Pregnancy | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 13 | 8 |
Baseline characteristics
| Characteristic | Placebo | MT10109L 24U + Placebo | MT10109L 24U + MT10109L 20U | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 15 Participants | 10 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants | 156 Participants | 157 Participants | 393 Participants |
| Age, Continuous | 48.6 years STANDARD_DEVIATION 12.32 | 47.7 years STANDARD_DEVIATION 11.56 | 49.1 years STANDARD_DEVIATION 10.37 | 48.5 years STANDARD_DEVIATION 11.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 11 Participants | 10 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 82 Participants | 159 Participants | 157 Participants | 398 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 85 Participants | 161 Participants | 159 Participants | 405 Participants |
| Sex: Female, Male Female | 71 Participants | 143 Participants | 141 Participants | 355 Participants |
| Sex: Female, Male Male | 15 Participants | 28 Participants | 26 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 171 | 0 / 168 |
| other Total, other adverse events | 34 / 86 | 60 / 171 | 74 / 168 |
| serious Total, serious adverse events | 4 / 86 | 11 / 171 | 5 / 168 |
Outcome results
Primary
The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 30
The outcome measured is the percentage of participants who had a ≥2-grade improvement from baseline LCL severity at maximum smile according to investigator and participant FWS ratings at Day 30. Both the INVESTIGATOR AND PARTICIPANT evaluate the LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.
Time frame: Day 30
Population: The primary endpoint measurements were carried out using the Intent-To-Treat (ITT) analysis set, which was defined as all participants who were randomized. Multiple imputation method was used for missing variables in primary efficacy endpoint.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 30 | 0 Participants |
| MT10109L 24U + Placebo | The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 30 | 35 Participants |
| MT10109L 24U + MT10109L 20U | The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 30 | 38 Participants |
Secondary
Mean Change From Baseline in Diastolic Blood Pressure (BP)
The outcome reported here is the mean change in Diastolic BP from baseline to study exit.
Time frame: Baseline to Day 360
Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Diastolic Blood Pressure (BP) | -1.2 mmHg | Standard Deviation 8.61 |
| MT10109L 24U + Placebo | Mean Change From Baseline in Diastolic Blood Pressure (BP) | -1.4 mmHg | Standard Deviation 8.34 |
| MT10109L 24U + MT10109L 20U | Mean Change From Baseline in Diastolic Blood Pressure (BP) | -0.7 mmHg | Standard Deviation 9.28 |
Secondary
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate
The outcome reported here is a mean change in mean heart rate from baseline to study exit.
Time frame: Baseline to Day 360
Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate | 3.3 beats/min | Standard Deviation 10.34 |
| MT10109L 24U + Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate | 4.2 beats/min | Standard Deviation 9.35 |
| MT10109L 24U + MT10109L 20U | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate | 2.7 beats/min | Standard Deviation 8.34 |
Secondary
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
The outcome reported here is a mean change in PR interval from baseline to study exit.
Time frame: Baseline to Day 360
Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval | -0.5 milliseconds | Standard Deviation 9.36 |
| MT10109L 24U + Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval | -0.7 milliseconds | Standard Deviation 12.37 |
| MT10109L 24U + MT10109L 20U | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval | 0.0 milliseconds | Standard Deviation 11.09 |
Secondary
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
The outcome reported here is a mean change in QRS duration from baseline to study exit.
Time frame: Baseline to Day 360
Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration | 0.0 milliseconds | Standard Deviation 6.16 |
| MT10109L 24U + Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration | 0.4 milliseconds | Standard Deviation 5.35 |
| MT10109L 24U + MT10109L 20U | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration | 1.6 milliseconds | Standard Deviation 8.06 |
Secondary
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
The outcome reported here is a mean change in QTcB interval from baseline to study exit.
Time frame: Baseline to Day 360
Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval | 0.9 milliseconds | Standard Deviation 17.34 |
| MT10109L 24U + Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval | 1.6 milliseconds | Standard Deviation 16.64 |
| MT10109L 24U + MT10109L 20U | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval | -1.5 milliseconds | Standard Deviation 16.3 |
Secondary
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
The outcome reported here is a mean change in QTcF interval from baseline to study exit.
Time frame: Baseline to Day 360
Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval | -2.4 milliseconds | Standard Deviation 14.21 |
| MT10109L 24U + Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval | -2.7 milliseconds | Standard Deviation 13.57 |
| MT10109L 24U + MT10109L 20U | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval | -4.2 milliseconds | Standard Deviation 13.65 |
Secondary
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
The outcome reported here is a mean change in QT interval from baseline to study exit.
Time frame: Baseline to Day 360
Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval | -8.6 milliseconds | Standard Deviation 25.07 |
| MT10109L 24U + Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval | -10.4 milliseconds | Standard Deviation 21.96 |
| MT10109L 24U + MT10109L 20U | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval | -9.2 milliseconds | Standard Deviation 21.26 |
Secondary
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
The outcome reported here is a mean change in RR interval from baseline to study exit.
Time frame: Baseline to Day 360
Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval | -42.6 milliseconds | Standard Deviation 137.27 |
| MT10109L 24U + Placebo | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval | -53.0 milliseconds | Standard Deviation 120.85 |
| MT10109L 24U + MT10109L 20U | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval | -35.0 milliseconds | Standard Deviation 114.66 |
Secondary
Mean Change From Baseline in Pulse Rate
The outcome reported here is the mean change in Pulse Rate from baseline to study exit.
Time frame: Baseline to Day 360
Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Pulse Rate | -0.7 beats/min | Standard Deviation 11.2 |
| MT10109L 24U + Placebo | Mean Change From Baseline in Pulse Rate | 0.9 beats/min | Standard Deviation 10.54 |
| MT10109L 24U + MT10109L 20U | Mean Change From Baseline in Pulse Rate | -0.4 beats/min | Standard Deviation 11.34 |
Secondary
Mean Change From Baseline in Respiratory Rate
The outcome reported here is the mean change in Respiratory Rate from baseline to study exit.
Time frame: Baseline to Day 360
Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Respiratory Rate | -0.4 breaths/min | Standard Deviation 2.03 |
| MT10109L 24U + Placebo | Mean Change From Baseline in Respiratory Rate | -0.3 breaths/min | Standard Deviation 2.04 |
| MT10109L 24U + MT10109L 20U | Mean Change From Baseline in Respiratory Rate | -0.6 breaths/min | Standard Deviation 2.47 |
Secondary
Mean Change From Baseline in Systolic Blood Pressure (BP)
The outcome reported here is the mean change in Systolic BP from baseline to study exit.
Time frame: Baseline to Day 360
Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (BP) | 1.0 mmHg | Standard Deviation 11.6 |
| MT10109L 24U + Placebo | Mean Change From Baseline in Systolic Blood Pressure (BP) | -0.4 mmHg | Standard Deviation 12.29 |
| MT10109L 24U + MT10109L 20U | Mean Change From Baseline in Systolic Blood Pressure (BP) | -0.3 mmHg | Standard Deviation 13.67 |
Secondary
Number of Participants With Binding and Neutralizing Antibodies
Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.
Time frame: Baseline to Day 360
Population: The population analyzed for this outcome was the subset of participants from the Safety population remaining at study exit. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Binding and Neutralizing Antibodies | 0 Participants |
| MT10109L 24U + Placebo | Number of Participants With Binding and Neutralizing Antibodies | 0 Participants |
| MT10109L 24U + MT10109L 20U | Number of Participants With Binding and Neutralizing Antibodies | 0 Participants |
Secondary
Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs)
This section focuses primarily on TEAEs, i.e., AEs that started or worsened after the first dose of study intervention and within 30 days after the last dose. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.
Time frame: AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose.
Population: All safety analyses were carried out using the Safety population set or subset, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs) | 50 Participants |
| MT10109L 24U + Placebo | Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs) | 90 Participants |
| MT10109L 24U + MT10109L 20U | Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs) | 106 Participants |
Secondary
The Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the FWS
The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Time frame: Day 1 (first treatment) to Day 180
Population: All secondary efficacy analyses were carried out using the Intent-To-Treat (ITT) analysis subset, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data. The participant analyzed here corresponds to the responders in Outcome 2.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MT10109L 24U + Placebo | The Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the FWS | 113 Days |
| MT10109L 24U + MT10109L 20U | The Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the FWS | 93 Days |
Secondary
The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL)
The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.
Time frame: Day 60
Population: All secondary efficacy analyses were carried out using the Intent-To-Treat (ITT) analysis set or subset, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL) | 8 Participants |
| MT10109L 24U + Placebo | The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL) | 97 Participants |
| MT10109L 24U + MT10109L 20U | The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL) | 122 Participants |
Secondary
The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS)
The outcome here only considers the INVESTIGATOR assessments (excludes the participant assessment). The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. A Responder was defined as one achieving a ≥2-grade improvement from baseline at maximum smile at Day 30.
Time frame: Day 30
Population: All secondary efficacy analyses were carried out using the Intent-To-Treat (ITT) analysis subset, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS) | 0 Participants |
| MT10109L 24U + Placebo | The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS) | 59 Participants |
| MT10109L 24U + MT10109L 20U | The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS) | 64 Participants |
Secondary
The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)
The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. Among Participants Who Were Rated At least Mild at Rest at Baseline, where a Responder was Defined as Achieving a ≥1-grade Improvement from Baseline at Day 30. The outcome measured here is the proportion of participants who achieved a ≥1-grade improvement from baseline LCL severity at rest based on investigator FWS rating.
Time frame: Day 30
Population: All secondary efficacy analyses were carried out using the Intent-To-Treat (ITT) analysis subset, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS) | 13 Participants |
| MT10109L 24U + Placebo | The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS) | 106 Participants |
| MT10109L 24U + MT10109L 20U | The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS) | 107 Participants |