Trial Outcomes & Findings for MT10109L in the Treatment of Glabellar Lines (NCT NCT03795922)
NCT ID: NCT03795922
Last Updated: 2023-07-27
Results Overview
The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 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.
COMPLETED
PHASE3
234 participants
Day 30
2023-07-27
Participant Flow
234 met the inclusion/exclusion criteria and were randomized.
Participant milestones
| Measure |
Placebo/MT10109L
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
154
|
|
Overall Study
COMPLETED
|
67
|
129
|
|
Overall Study
NOT COMPLETED
|
13
|
25
|
Reasons for withdrawal
| Measure |
Placebo/MT10109L
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
13
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Other (Early termination, COVID, Family issue)
|
3
|
4
|
Baseline Characteristics
MT10109L in the Treatment of Glabellar Lines
Baseline characteristics by cohort
| Measure |
Placebo/MT10109L
n=80 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=154 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
Total
n=234 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
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=99 Participants
|
141 Participants
n=107 Participants
|
218 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 11.57 • n=99 Participants
|
47.3 years
STANDARD_DEVIATION 12.64 • n=107 Participants
|
47.0 years
STANDARD_DEVIATION 12.27 • n=206 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
216 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=99 Participants
|
144 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=99 Participants
|
146 Participants
n=107 Participants
|
222 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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 primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 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.
Outcome measures
| Measure |
Placebo/MT10109L
n=80 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=154 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
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
|
0 Participants
|
71 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 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 of double-blind period. 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/MT10109L
n=77 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=153 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions 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)
|
1 Participants
|
94 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-gradeimprovement from baseline in GL severity at maximum frown at Day 30 of double-blind period according to investigator assessments using the Facial Wrinkle Scale (FWS). This corresponds to the responders for Outcome 2. 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 (i.e., return to moderate or severe GL severity at maximum frown using the FWS).
Outcome measures
| Measure |
Placebo/MT10109L
n=1 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=94 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
The Duration of Glabellar Lines (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)
|
64 Days
95% Confidence Interval cannot be calculated as there was only 1 responder.
|
121 Days
Interval 113.0 to 145.0
|
SECONDARY outcome
Timeframe: Day 60Population: All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which wasdefined as all participants who were randomized. Analyses of the secondary efficacy variables wereperformed 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/MT10109L
n=72 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=145 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions 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)
|
7 Participants
|
121 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 of double-blind period. 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/MT10109L
n=73 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=140 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS).
|
23 Participants
|
95 Participants
|
SECONDARY outcome
Timeframe: The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).Population: All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
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/MT10109L
n=80 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=223 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration
|
35 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: Baseline to Study exit (Day 360 or early exit)Population: All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.
Change from baseline at study exit.
Outcome measures
| Measure |
Placebo/MT10109L
n=73 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=133 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)
|
0.3 mmHg
Standard Deviation 13.26
|
-0.6 mmHg
Standard Deviation 15.28
|
SECONDARY outcome
Timeframe: Baseline to Study exit (Day 360 or early exit)Population: All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.
Change from baseline at study exit.
Outcome measures
| Measure |
Placebo/MT10109L
n=73 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=133 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)
|
0.5 mmHg
Standard Deviation 10.04
|
-1.9 mmHg
Standard Deviation 10.64
|
SECONDARY outcome
Timeframe: Baseline to Study exit (Day 360 or early exit)Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.
Change from baseline at study exit.
Outcome measures
| Measure |
Placebo/MT10109L
n=73 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=133 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Mean Change From Baseline in Vital Signs - Pulse Rate
|
2.5 beats/min
Standard Deviation 10.35
|
0.4 beats/min
Standard Deviation 10.54
|
SECONDARY outcome
Timeframe: Baseline to Study exit (Day 360 or early exit)Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.
Change from baseline at study exit.
Outcome measures
| Measure |
Placebo/MT10109L
n=73 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=133 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Mean Change From Baseline in Vital Signs - Respiratory Rate
|
-0.3 breaths/min
Standard Deviation 2.44
|
-0.3 breaths/min
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: Baseline to Study Exit (Day 360 or early exit)Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.
Change from baseline at study exit.
Outcome measures
| Measure |
Placebo/MT10109L
n=70 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=130 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate
|
4.8 beats/min
Standard Deviation 10.38
|
2.8 beats/min
Standard Deviation 8.52
|
SECONDARY outcome
Timeframe: Baseline to Study Exit (Day 360 or early exit)Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.
Change from baseline at study exit.
Outcome measures
| Measure |
Placebo/MT10109L
n=70 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=130 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
|
-1.2 milliseconds
Standard Deviation 11.67
|
-1.2 milliseconds
Standard Deviation 11.91
|
SECONDARY outcome
Timeframe: Baseline to Study Exit (Day 360 or early exit)Population: All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.
Change from baseline at study exit.
Outcome measures
| Measure |
Placebo/MT10109L
n=70 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=130 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
|
0.4 milliseconds
Standard Deviation 6.65
|
1.2 milliseconds
Standard Deviation 6.41
|
SECONDARY outcome
Timeframe: Baseline to Study Exit (Day 360 or early exit)Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.
Change from baseline at study exit.
Outcome measures
| Measure |
Placebo/MT10109L
n=70 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=130 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
|
-11.7 milliseconds
Standard Deviation 23.87
|
-8.4 milliseconds
Standard Deviation 19.71
|
SECONDARY outcome
Timeframe: Baseline to Study Exit (Day 360 or early exit)Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.
Change from baseline at study exit.
Outcome measures
| Measure |
Placebo/MT10109L
n=70 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=130 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
|
2.7 milliseconds
Standard Deviation 18.69
|
0.0 milliseconds
Standard Deviation 17.14
|
SECONDARY outcome
Timeframe: Baseline to Study Exit (Day 360 or early exit)Population: All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.
Change from baseline at study exit.
Outcome measures
| Measure |
Placebo/MT10109L
n=70 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=130 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
|
-2.4 milliseconds
Standard Deviation 15.43
|
-2.9 milliseconds
Standard Deviation 14.06
|
SECONDARY outcome
Timeframe: Baseline to Study Exit (Day 360 or early exit)Population: All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.
Change from baseline at study exit.
Outcome measures
| Measure |
Placebo/MT10109L
n=70 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=130 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
|
-64.6 milliseconds
Standard Deviation 127.1
|
-39.3 milliseconds
Standard Deviation 106.19
|
SECONDARY outcome
Timeframe: Up to Study Exit (Day 360 or early exit)Population: All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention.
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/MT10109L
n=80 Participants
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.
|
MT10109L/MT10109L
n=154 Participants
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
|
|---|---|---|
|
Number of Participants With Binding and Neutralizing Antibodies
|
1 Participants
|
0 Participants
|
Adverse Events
Placebo
MT10109L
Serious adverse events
| Measure |
Placebo
n=80 participants at risk
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part post day 180, up to 2 open-label study interventions during the retreatment period. Placebo participants were allowed to enter open-label phase for retreatment but the TEAEs with onset date after the retreatment were not counted here.
|
MT10109L
n=223 participants at risk
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. Placebo participants who experienced TEAE after receiving MT10109L during open-label phase were counted here.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
1.2%
1/80 • Number of events 1 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
0.00%
0/223 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/80 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
0.45%
1/223 • Number of events 1 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
|
Infections and infestations
Pneumonia
|
1.2%
1/80 • Number of events 1 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
0.00%
0/223 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/80 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
0.45%
1/223 • Number of events 1 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/80 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
0.45%
1/223 • Number of events 1 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/80 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
0.45%
1/223 • Number of events 1 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.2%
1/80 • Number of events 1 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
0.00%
0/223 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.2%
1/80 • Number of events 1 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
0.00%
0/223 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/80 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
0.45%
1/223 • Number of events 1 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Stage II
|
0.00%
0/80 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
0.45%
1/223 • Number of events 1 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma in situ
|
0.00%
0/80 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
0.45%
1/223 • Number of events 1 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
Other adverse events
| Measure |
Placebo
n=80 participants at risk
Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part post day 180, up to 2 open-label study interventions during the retreatment period. Placebo participants were allowed to enter open-label phase for retreatment but the TEAEs with onset date after the retreatment were not counted here.
|
MT10109L
n=223 participants at risk
MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. Placebo participants who experienced TEAE after receiving MT10109L during open-label phase were counted here.
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.0%
4/80 • Number of events 4 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
9.9%
22/223 • Number of events 22 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
|
General disorders
Injection site pain
|
5.0%
4/80 • Number of events 4 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
7.2%
16/223 • Number of events 16 • The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.
|
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