Trial Outcomes & Findings for MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL) (NCT NCT03721016)
NCT ID: NCT03721016
Last Updated: 2023-05-25
Results Overview
The outcome measured is 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 Glabellar Lines (GL) severity at maximum frown at Day 30. The investigator and participant evaluates the participant's GL severity using a Facial Wrinkle Scale With Photonumeric Guide (FWS) at maximum frown on Day 30. The scale ranges from (0 to 3) where 0=none and 3 = severe.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
415 participants
Primary outcome timeframe
Day 30
Results posted on
2023-05-25
Participant Flow
415 met the inclusion/exclusion criteria and were randomized.
Participant milestones
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into and Lateral Canthal Lines (LCL)
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
82
|
173
|
160
|
|
Overall Study
COMPLETED
|
66
|
141
|
133
|
|
Overall Study
NOT COMPLETED
|
16
|
32
|
27
|
Reasons for withdrawal
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into and Lateral Canthal Lines (LCL)
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
16
|
13
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
5
|
|
Overall Study
Physician Decision
|
0
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Site terminated by sponsor
|
3
|
7
|
6
|
|
Overall Study
Subject exited early due to COVID-19
|
1
|
0
|
0
|
Baseline Characteristics
MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)
Baseline characteristics by cohort
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=82 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=173 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=160 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
Total
n=415 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
78 Participants
n=99 Participants
|
160 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
394 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Age, Continuous
|
47.6 Years
STANDARD_DEVIATION 10.91 • n=99 Participants
|
47.5 Years
STANDARD_DEVIATION 11.49 • n=107 Participants
|
46.2 Years
STANDARD_DEVIATION 11.15 • n=206 Participants
|
47 Years
STANDARD_DEVIATION 11.23 • n=7 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
363 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
349 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=99 Participants
|
168 Participants
n=107 Participants
|
151 Participants
n=206 Participants
|
394 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 30Population: All primary and secondary efficacy analyses endpoints 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. Analyses of the secondary efficacy variables were performed using observed data.
The outcome measured is 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 Glabellar Lines (GL) severity at maximum frown at Day 30. The investigator and participant evaluates the participant's GL severity using a Facial Wrinkle Scale With Photonumeric Guide (FWS) at maximum frown on Day 30. The scale ranges from (0 to 3) where 0=none and 3 = severe.
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=82 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=173 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=160 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS)
|
0 Participants
|
78 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: Day 1 (first treatment) to Day 180Population: The analysis population for this outcome includes the participants who achieved a rating of ≥ 2-grade improvement from baseline in GL severity at maximum frown at Day 30 according to investigator assessments using the Facial Wrinkle Scale (FWS). This corresponds to the responders for Outcome 3. NA means no participant from the group achieved a rating of ≥ 2-grade improvement from baseline in GL severity. Note: Analyses of the secondary efficacy variables were performed using observed data.
The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (ie, return to moderate or severe GL severity at maximum frown using the FWS).
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=83 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=83 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
The Duration of Glabellar Line (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS)
|
—
|
116.0 days
Interval 92.0 to 128.0
|
118.0 days
Interval 94.0 to 132.0
|
SECONDARY outcome
Timeframe: Day 30Population: All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.
The percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=81 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=163 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=154 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)
|
0 Participants
|
83 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: Day 60Population: All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data
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.
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=74 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=159 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=150 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL)
|
4 Participants
|
116 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: Day 30Population: All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.
The outcome was measured 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 investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=76 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=152 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=140 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS)
|
11 Participants
|
84 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: The time frame for AEs is after the first dose (Day 1) and up to 30 days after their last visit or study exit (Day 360 unless participant exits earlier)Population: All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=82 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=174 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=159 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Secondary Safety: Number of Patients Who Experienced an Adverse Event (AE)
|
31 Participants
|
82 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 360 (Study exit)Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.
Changes in vital signs: Systolic BP
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=69 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=151 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=135 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure (BP)
|
2.5 Change in mmHg
Standard Deviation 12.81
|
0 Change in mmHg
Standard Deviation 12.33
|
-1.7 Change in mmHg
Standard Deviation 12.26
|
SECONDARY outcome
Timeframe: Baseline to Day 360 (Study exit)Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.
Changes in vital signs: Diastolic BP
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=69 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=151 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=135 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Mean Change From Baseline in Diastolic Blood Pressure (BP)
|
-1.4 Change in mmHg
Standard Deviation 7.81
|
-0.9 Change in mmHg
Standard Deviation 10.07
|
-0.8 Change in mmHg
Standard Deviation 8.64
|
SECONDARY outcome
Timeframe: Baseline to Day 360 (Study exit)Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.
Changes in vital signs: Pulse Rate
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=69 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=151 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=135 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Mean Change From Baseline in Pulse Rate
|
-1.7 Change in beats/min
Standard Deviation 11.25
|
-1 Change in beats/min
Standard Deviation 10.3
|
-1 Change in beats/min
Standard Deviation 8.93
|
SECONDARY outcome
Timeframe: Baseline to Day 360 (Study exit)Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.
Changes in vital signs: Respiratory Rate
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=69 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=151 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=135 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Mean Change From Baseline in Respiratory Rate
|
0 Change in breaths/min
Standard Deviation 2.13
|
0.1 Change in breaths/min
Standard Deviation 2.28
|
-0.2 Change in breaths/min
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: Baseline to Day 360Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.
Change from baseline for ECG safety population - Heart Rate
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=67 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=152 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=134 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate
|
3.6 Change from baseline in beats/min
Standard Deviation 9.79
|
2.4 Change from baseline in beats/min
Standard Deviation 8.41
|
3.4 Change from baseline in beats/min
Standard Deviation 9.51
|
SECONDARY outcome
Timeframe: Baseline to Day 360Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.
Change from baseline for ECG safety population - PR Interval
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=67 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=152 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=133 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
|
-3.2 Change from baseline in msec
Standard Deviation 14.41
|
-0.5 Change from baseline in msec
Standard Deviation 12.41
|
-0.7 Change from baseline in msec
Standard Deviation 11.13
|
SECONDARY outcome
Timeframe: Baseline to Day 360Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.
Change from baseline for ECG safety population - QRS duration
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=67 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=152 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=134 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
|
0.9 Change from baseline in msec
Standard Deviation 5.78
|
1.1 Change from baseline in msec
Standard Deviation 6.08
|
0.8 Change from baseline in msec
Standard Deviation 6.06
|
SECONDARY outcome
Timeframe: Baseline to Day 360Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.
Change from baseline for ECG safety population - QT interval
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=67 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=152 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=134 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
|
-10.4 Change from baseline in msec
Standard Deviation 23.88
|
-5.6 Change from baseline in msec
Standard Deviation 21.0
|
-8.0 Change from baseline in msec
Standard Deviation 22.69
|
SECONDARY outcome
Timeframe: Baseline to Day 360Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.
Change from baseline for ECG safety population - QTcB interval
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=67 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=152 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=134 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
|
0.1 Change from baseline in msec
Standard Deviation 15.5
|
1.2 Change from baseline in msec
Standard Deviation 18.92
|
1.7 Change from baseline in msec
Standard Deviation 17.65
|
SECONDARY outcome
Timeframe: Baseline to Day 360Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.
Change from baseline for ECG safety population - QTcF interval
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=67 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=152 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=134 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
|
-3.5 Change from baseline in msec
Standard Deviation 14.19
|
-1.2 Change from baseline in msec
Standard Deviation 15.91
|
-1.8 Change from baseline in msec
Standard Deviation 14.47
|
SECONDARY outcome
Timeframe: Baseline to Day 360Population: All safety analyses were carried out using the Safety population, which was defined as all participants who received at least 1 dose of study intervention. In Safety population, participants were grouped based on their actual treatment received and not planned treatment. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline (Day 360) during that analysis visit were used.
Change from baseline for ECG safety population - RR interval
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=67 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=152 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=134 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
|
-46.0 Change from baseline in msec
Standard Deviation 113.98
|
-31.0 Change from baseline in msec
Standard Deviation 113.11
|
-44.6 Change from baseline in msec
Standard Deviation 122.53
|
SECONDARY outcome
Timeframe: Day 360Population: All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
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.
Outcome measures
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=82 Participants
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=174 Participants
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=159 Participants
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Number of Participants With Binding and Neutralizing Antibodies
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=82 participants at risk
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=174 participants at risk
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=159 participants at risk
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
1.2%
1/82 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.00%
0/174 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.00%
0/159 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/82 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.00%
0/174 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.63%
1/159 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
|
General disorders
Pyrexia
|
0.00%
0/82 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.00%
0/174 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.63%
1/159 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/82 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.00%
0/174 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.63%
1/159 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/82 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.00%
0/174 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.63%
1/159 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/82 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.57%
1/174 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.00%
0/159 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.2%
1/82 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.00%
0/174 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.63%
1/159 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/82 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.00%
0/174 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.63%
1/159 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/82 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.57%
1/174 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.00%
0/159 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/82 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.00%
0/174 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.63%
1/159 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
|
Reproductive system and breast disorders
Endometriosis [F]
|
0.00%
0/82 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.57%
1/174 • Number of events 1 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
0.00%
0/159 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
Other adverse events
| Measure |
Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
n=82 participants at risk
Placebo was injected into the GL and into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL)
n=174 participants at risk
MT10109L Dose 1 was injected into the GL and Placebo into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL)
n=159 participants at risk
MT10109L Dose 1 was injected into the GL and MT10109L Dose 2 into the LCL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
4.9%
4/82 • Number of events 4 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
8.0%
14/174 • Number of events 14 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
3.8%
6/159 • Number of events 6 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
|
General disorders
Injection site pain
|
4.9%
4/82 • Number of events 4 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
5.2%
9/174 • Number of events 9 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
4.4%
7/159 • Number of events 7 • This section describes Treatment-Emergent Adverse Events (TEAEs) that started or worsened after the first dose of study intervention and within 30 days after the last visit or study exit (Day 360 unless the participant exits earlier)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. NOTE - 1 Participant randomized to 'Dose1 + Dose2' actually received treatment in the 'Dose1 + Placebo'. Therefore, the total number of participants analyzed in the 'MT10109L Dose 1 into GL + Placebo into LCL' arm is 174 instead of 173 that started in this arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee General research agreement between the sponsor and PI's that includes a confidentiality section that includes a statement that the sponsor is and shall remain the exclusive owner of 'Information'. ) 'Information' shall include, but shall not be limited to, protocols, trade secrets, know-how, formulations, inventions, techniques, equipment, data and results.
- Publication restrictions are in place
Restriction type: OTHER