A Phase 3 interventional study of MT10109L and Placebo in Glabellar Lines and Lateral Canthal Lines, sponsored by Medy-Tox. Completed at 21 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Medy-Tox · Phase 3, Interventional, and Treatment
To evaluate the safety and efficacy of MT10109L for the treatment of glabellar lines (GL) with or without concurrent treatment of lateral canthal lines (LCL) in participants with moderate to severe GL and LCL.
Medy-Tox is the lead sponsor of 49 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MT10109L Dose 1 will be injected into the Glabellar Lines (GL) and Placebo into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Drug: MT10109L · Drug: Placebo
MT10109L Dose 1 will be injected into the Glabellar Lines (GL) and MT10109L Dose 2 into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Drug: MT10109L
Placebo will be injected into the Glabellar Lines (GL) and into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
Drug: Placebo
MT10109Lwill be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.
Also known as: NivobotulinumtoxinA
Placebo will be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.
The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS)
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.
Time frame: Day 30
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)
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).
Time frame: Day 1 (first treatment) to Day 180
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)
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.
Time frame: Day 30
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)
The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.
Time frame: Day 60
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS)
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.
Time frame: Day 30
Secondary Safety: Number of Patients Who Experienced an Adverse Event (AE)
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.
Time frame: 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)
Mean Change From Baseline in Systolic Blood Pressure (BP)
Changes in vital signs: Systolic BP
Time frame: Baseline to Day 360 (Study exit)
Mean Change From Baseline in Diastolic Blood Pressure (BP)
Changes in vital signs: Diastolic BP
Time frame: Baseline to Day 360 (Study exit)
Mean Change From Baseline in Pulse Rate
Changes in vital signs: Pulse Rate
Time frame: Baseline to Day 360 (Study exit)
Mean Change From Baseline in Respiratory Rate
Changes in vital signs: Respiratory Rate
Time frame: Baseline to Day 360 (Study exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate
Change from baseline for ECG safety population - Heart Rate
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
Change from baseline for ECG safety population - PR Interval
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
Change from baseline for ECG safety population - QRS duration
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
Change from baseline for ECG safety population - QT interval
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
Change from baseline for ECG safety population - QTcB interval
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
Change from baseline for ECG safety population - QTcF interval
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
Change from baseline for ECG safety population - RR interval
Time frame: Baseline to Day 360
Number of Participants With Binding and Neutralizing Antibodies
Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.
Time frame: Day 360
| Milestone | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Started | 82 | 173 | 160 |
| Completed | 66 | 141 | 133 |
| Not completed | 16 | 32 | 27 |
| Withdrew: Adverse event | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 8 | 16 | 13 |
| Withdrew: Lost to follow-up | 4 | 6 | 5 |
| Withdrew: Physician decision | 0 | 1 | 2 |
| Withdrew: Protocol violation | 0 | 1 | 0 |
| Withdrew: Site terminated by sponsor | 3 | 7 | 6 |
| Withdrew: Subject exited early due to covid-19 | 1 | 0 | 0 |
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.
| Participants | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) | 0 | 78 | 66 |
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).
| days | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| 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 (92 to 128) | 118.0 (94 to 132) |
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.
| Participants | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS) | 0 | 83 | 83 |
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.
| Participants | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| 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 | 116 | 118 |
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.
| Participants | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS) | 11 | 84 | 100 |
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.
| Participants | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Secondary Safety: Number of Patients Who Experienced an Adverse Event (AE) | 31 | 82 | 61 |
Changes in vital signs: Systolic BP
| Change in mmHg | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Mean Change From Baseline in Systolic Blood Pressure (BP) | 2.5 ± 12.81 | 0 ± 12.33 | -1.7 ± 12.26 |
Changes in vital signs: Diastolic BP
| Change in mmHg | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Mean Change From Baseline in Diastolic Blood Pressure (BP) | -1.4 ± 7.81 | -0.9 ± 10.07 | -0.8 ± 8.64 |
Changes in vital signs: Pulse Rate
| Change in beats/min | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Mean Change From Baseline in Pulse Rate | -1.7 ± 11.25 | -1 ± 10.3 | -1 ± 8.93 |
Changes in vital signs: Respiratory Rate
| Change in breaths/min | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Mean Change From Baseline in Respiratory Rate | 0 ± 2.13 | 0.1 ± 2.28 | -0.2 ± 2.21 |
Change from baseline for ECG safety population - Heart Rate
| Change from baseline in beats/min | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate | 3.6 ± 9.79 | 2.4 ± 8.41 | 3.4 ± 9.51 |
Change from baseline for ECG safety population - PR Interval
| Change from baseline in msec | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval | -3.2 ± 14.41 | -0.5 ± 12.41 | -0.7 ± 11.13 |
Change from baseline for ECG safety population - QRS duration
| Change from baseline in msec | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration | 0.9 ± 5.78 | 1.1 ± 6.08 | 0.8 ± 6.06 |
Change from baseline for ECG safety population - QT interval
| Change from baseline in msec | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval | -10.4 ± 23.88 | -5.6 ± 21.0 | -8.0 ± 22.69 |
Change from baseline for ECG safety population - QTcB interval
| Change from baseline in msec | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval | 0.1 ± 15.5 | 1.2 ± 18.92 | 1.7 ± 17.65 |
Change from baseline for ECG safety population - QTcF interval
| Change from baseline in msec | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval | -3.5 ± 14.19 | -1.2 ± 15.91 | -1.8 ± 14.47 |
Change from baseline for ECG safety population - RR interval
| Change from baseline in msec | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval | -46.0 ± 113.98 | -31.0 ± 113.11 | -44.6 ± 122.53 |
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.
| Participants | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| Number of Participants With Binding and Neutralizing Antibodies | 0 | 0 | 1 |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | 0/82 (0%) | 2/82 (2.4%) | 7/82 (8.5%) |
| MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | 0/174 (0%) | 3/174 (1.7%) | 22/174 (12.6%) |
| MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) | 0/159 (0%) | 5/159 (3.1%) | 13/159 (8.2%) |
| Event | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| AppendicitisInfections and infestations | 1/82 | 0/174 | 0/159 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/82 | 0/174 | 1/159 |
| DiarrheaGastrointestinal disorders | 0/82 | 0/174 | 1/159 |
| PyrexiaGeneral disorders | 0/82 | 0/174 | 1/159 |
| DiverticulitisInfections and infestations | 0/82 | 0/174 | 1/159 |
| SepsisInfections and infestations | 0/82 | 0/174 | 1/159 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/82 | 0/174 | 1/159 |
| Cerebrovascular accidentNervous system disorders | 0/82 | 0/174 | 1/159 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/82 | 1/174 | 0/159 |
| Intraductal proliferative breast lesionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/82 | 1/174 | 0/159 |
| Event | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) |
|---|---|---|---|
| HeadacheNervous system disorders | 4/82 | 14/174 | 6/159 |
| Injection site painGeneral disorders | 4/82 | 9/174 | 7/159 |
There were 415 participants included in the Intent To Treat (ITT) population (160 participants in the MT10109L Dose 1+2 group, 173 participants in the MT10109L Dose 1 group, and 82 participants in the placebo group).
| Age, Categorical(Participants) | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 78 | 160 | 156 | 394 |
| >=65 years | 4 | 13 | 4 | 21 |
| Age, Continuous(Years) | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) | Total |
|---|---|---|---|---|
| Mean | 47.6 ± 10.91 | 47.5 ± 11.49 | 46.2 ± 11.15 | 47 ± 11.23 |
| Sex: Female, Male(Participants) | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) | Total |
|---|---|---|---|---|
| Female | 72 | 148 | 143 | 363 |
| Male | 10 | 25 | 17 | 52 |
| Ethnicity (NIH/OMB)(Participants) | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 13 | 25 | 28 | 66 |
| Not Hispanic or Latino | 69 | 148 | 132 | 349 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo Into Both Glabellar Lines (GL) and Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL) + Placebo Into Lateral Canthal Lines (LCL) | MT10109L Dose 1 Into Glabellar Lines (GL)+ MT10109L Dose 2 Into Lateral Canthal Lines (LCL) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 2 | 3 |
| Asian | 2 | 3 | 3 | 8 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 3 | 1 | 2 | 6 |
| White | 75 | 168 | 151 | 394 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 2 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2018 to primary completion in Mar 2020, 16 months.
Results were first posted in Apr 2023, 3 years 1 month after primary completion. A results delay was requested in Mar 2021.
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Studies of the drug tested here: Nivobotulinumtoxina