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CompletedNCT03732833Updated Jul 17, 2023Results posted

MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines

A Phase 3 interventional study of MT10109L and Placebo in Lateral Canthal Lines and Glabellar Lines, sponsored by Medy-Tox. Completed at 20 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-17.

Sponsored by Medy-Tox · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
425
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the safety and efficacy of MT10109L for the treatment of lateral canthal lines (LCL) with or without concurrent treatment of glabellar lines (GL) in participants with moderate to severe LCL and GL.

02

Conditions studied

  • Lateral Canthal Lines
  • Glabellar Lines
03

In context

Lead sponsor

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.

Browse Medy-Tox studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

-Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.

Exclusion criteria

Exclusion Criteria:

  • Known immunization or to any botulinum toxin serotype.
  • Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
  • History of facial nerve palsy.
  • Any uncontrolled systemic disease.
  • Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention).
  • Anticipated need for surgery or overnight hospitalization during the study.
  • Prior exposure to botulinum toxin of any serotype for any reason.
  • Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).
  • Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation.
  • Current enrollment in an drug or device study or participation in such a study within 30 days of entry into this study.
  • Females who are pregnant, nursing, or planning a pregnancy during the study.
  • Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
425 participants (actual)

Study arms

  • Experimental
    MT10109L Dose 1 + Placebo

    MT10109L Dose 1 will be injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.

    Drug: MT10109L · Drug: Placebo

  • Experimental
    MT10109L Dose 1 + MT10109L Dose 2

    MT10109L Dose 1 will be injected into the LCL and MT10109L Dose 2 into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.

    Drug: MT10109L

  • Placebo comparator
    Placebo

    Placebo will be injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.

    Drug: Placebo

Interventions

  • DrugMT10109L

    MT10109L will be injected into either the LCL, or both the LCL and GL.

    Also known as: NivobotulinumtoxinA

  • DrugPlacebo

    Placebo will be injected into either the GL, or both the LCL and GL.

06

What researchers measure

Primary outcomes

  1. The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 30

    The outcome measured is the percentage of participants who had a ≥2-grade improvement from baseline LCL severity at maximum smile according to investigator and participant FWS ratings at Day 30. Both the INVESTIGATOR AND PARTICIPANT evaluate the LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.

    Time frame: Day 30

Secondary outcomes

  1. The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS)

    The outcome here only considers the INVESTIGATOR assessments (excludes the participant assessment). The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. A Responder was defined as one achieving a ≥2-grade improvement from baseline at maximum smile at Day 30.

    Time frame: Day 30

  2. The Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the FWS

    The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

    Time frame: Day 1 (first treatment) to Day 180

  3. The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL)

    The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.

    Time frame: Day 60

  4. The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)

    The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. Among Participants Who Were Rated At least Mild at Rest at Baseline, where a Responder was Defined as Achieving a ≥1-grade Improvement from Baseline at Day 30. The outcome measured here is the proportion of participants who achieved a ≥1-grade improvement from baseline LCL severity at rest based on investigator FWS rating.

    Time frame: Day 30

  5. Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs)

    This section focuses primarily on TEAEs, i.e., AEs that started or worsened after the first dose of study intervention and within 30 days after the last dose. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.

    Time frame: AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose.

  6. Mean Change From Baseline in Systolic Blood Pressure (BP)

    The outcome reported here is the mean change in Systolic BP from baseline to study exit.

    Time frame: Baseline to Day 360

  7. Mean Change From Baseline in Diastolic Blood Pressure (BP)

    The outcome reported here is the mean change in Diastolic BP from baseline to study exit.

    Time frame: Baseline to Day 360

  8. Mean Change From Baseline in Pulse Rate

    The outcome reported here is the mean change in Pulse Rate from baseline to study exit.

    Time frame: Baseline to Day 360

  9. Mean Change From Baseline in Respiratory Rate

    The outcome reported here is the mean change in Respiratory Rate from baseline to study exit.

    Time frame: Baseline to Day 360

  10. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate

    The outcome reported here is a mean change in mean heart rate from baseline to study exit.

    Time frame: Baseline to Day 360

  11. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval

    The outcome reported here is a mean change in PR interval from baseline to study exit.

    Time frame: Baseline to Day 360

  12. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration

    The outcome reported here is a mean change in QRS duration from baseline to study exit.

    Time frame: Baseline to Day 360

  13. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval

    The outcome reported here is a mean change in QT interval from baseline to study exit.

    Time frame: Baseline to Day 360

  14. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval

    The outcome reported here is a mean change in QTcB interval from baseline to study exit.

    Time frame: Baseline to Day 360

  15. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval

    The outcome reported here is a mean change in QTcF interval from baseline to study exit.

    Time frame: Baseline to Day 360

  16. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval

    The outcome reported here is a mean change in RR interval from baseline to study exit.

    Time frame: Baseline to Day 360

  17. Number of Participants With Binding and Neutralizing Antibodies

    Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.

    Time frame: Baseline to Day 360

07

Results

Posted Jul 17, 2023

Participant flow

Participant flow — Overall Study
MilestonePlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Started86171167
Completed68138150
Not completed183317
Withdrew: Adverse event031
Withdrew: Withdrawal by subject11138
Withdrew: Lost to follow-up354
Withdrew: Pregnancy020
Withdrew: Physician decision231
Withdrew: Covid-19 related and other reasons273

Outcome measures

PrimaryThe Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 30

The outcome measured is the percentage of participants who had a ≥2-grade improvement from baseline LCL severity at maximum smile according to investigator and participant FWS ratings at Day 30. Both the INVESTIGATOR AND PARTICIPANT evaluate the LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.

Time frame:
Day 30
Reported as:
Count of participants · Participants
The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 30
ParticipantsPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 3003538
SecondaryThe Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS)

The outcome here only considers the INVESTIGATOR assessments (excludes the participant assessment). The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. A Responder was defined as one achieving a ≥2-grade improvement from baseline at maximum smile at Day 30.

Time frame:
Day 30
Reported as:
Count of participants · Participants
The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS)
ParticipantsPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale With Photonumeric Guide (FWS)05964
SecondaryThe Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the FWS

The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

Time frame:
Day 1 (first treatment) to Day 180
Reported as:
Median · Days
The Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the FWS
DaysPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
The Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the FWS—113 (91 to 121)93 (89 to 118)
SecondaryThe Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL)

The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.

Time frame:
Day 60
Reported as:
Count of participants · Participants
The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL)
ParticipantsPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL)897122
SecondaryThe Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)

The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. Among Participants Who Were Rated At least Mild at Rest at Baseline, where a Responder was Defined as Achieving a ≥1-grade Improvement from Baseline at Day 30. The outcome measured here is the proportion of participants who achieved a ≥1-grade improvement from baseline LCL severity at rest based on investigator FWS rating.

Time frame:
Day 30
Reported as:
Count of participants · Participants
The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)
ParticipantsPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)13106107
SecondaryNumber of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs)

This section focuses primarily on TEAEs, i.e., AEs that started or worsened after the first dose of study intervention and within 30 days after the last dose. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.

Time frame:
AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose.
Reported as:
Count of participants · Participants
Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs)
ParticipantsPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs)5090106
SecondaryMean Change From Baseline in Systolic Blood Pressure (BP)

The outcome reported here is the mean change in Systolic BP from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · mmHg
Mean Change From Baseline in Systolic Blood Pressure (BP)
mmHgPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Mean Change From Baseline in Systolic Blood Pressure (BP)1.0 ± 11.60-0.4 ± 12.29-0.3 ± 13.67
SecondaryMean Change From Baseline in Diastolic Blood Pressure (BP)

The outcome reported here is the mean change in Diastolic BP from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · mmHg
Mean Change From Baseline in Diastolic Blood Pressure (BP)
mmHgPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Mean Change From Baseline in Diastolic Blood Pressure (BP)-1.2 ± 8.61-1.4 ± 8.34-0.7 ± 9.28
SecondaryMean Change From Baseline in Pulse Rate

The outcome reported here is the mean change in Pulse Rate from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · beats/min
Mean Change From Baseline in Pulse Rate
beats/minPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Mean Change From Baseline in Pulse Rate-0.7 ± 11.20.9 ± 10.54-0.4 ± 11.34
SecondaryMean Change From Baseline in Respiratory Rate

The outcome reported here is the mean change in Respiratory Rate from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · breaths/min
Mean Change From Baseline in Respiratory Rate
breaths/minPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Mean Change From Baseline in Respiratory Rate-0.4 ± 2.03-0.3 ± 2.04-0.6 ± 2.47
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate

The outcome reported here is a mean change in mean heart rate from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · beats/min
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate
beats/minPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate3.3 ± 10.344.2 ± 9.352.7 ± 8.34
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval

The outcome reported here is a mean change in PR interval from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
millisecondsPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval-0.5 ± 9.36-0.7 ± 12.370.0 ± 11.09
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration

The outcome reported here is a mean change in QRS duration from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
millisecondsPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration0.0 ± 6.160.4 ± 5.351.6 ± 8.06
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval

The outcome reported here is a mean change in QT interval from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
millisecondsPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval-8.6 ± 25.07-10.4 ± 21.96-9.2 ± 21.26
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval

The outcome reported here is a mean change in QTcB interval from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
millisecondsPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval0.9 ± 17.341.6 ± 16.64-1.5 ± 16.3
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval

The outcome reported here is a mean change in QTcF interval from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
millisecondsPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval-2.4 ± 14.21-2.7 ± 13.57-4.2 ± 13.65
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval

The outcome reported here is a mean change in RR interval from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
millisecondsPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval-42.6 ± 137.27-53.0 ± 120.85-35.0 ± 114.66
SecondaryNumber of Participants With Binding and Neutralizing Antibodies

Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.

Time frame:
Baseline to Day 360
Reported as:
Count of participants · Participants
Number of Participants With Binding and Neutralizing Antibodies
ParticipantsPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Number of Participants With Binding and Neutralizing Antibodies000

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/86 (0%)4/86 (4.7%)34/86 (39.5%)
MT10109L 24U + Placebo0/171 (0%)11/171 (6.4%)60/171 (35.1%)
MT10109L 24U + MT10109L 20U0/168 (0%)5/168 (3%)74/168 (44%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/863/1712/168
COVID-19Infections and infestations0/862/1710/168
ColitisGastrointestinal disorders1/861/1710/168
Colitis microscopicGastrointestinal disorders1/860/1710/168
Acute kidney injuryRenal and urinary disorders1/860/1710/168
Abortion induced [F]Surgical and medical procedures0/711/1430/141
Allergy to arthropod stingImmune system disorders0/860/1711/168
PneumoniaInfections and infestations0/860/1711/168
Intraductal proliferative breast lesionNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/860/1711/168
Aortic valve incompetenceCardiac disorders0/861/1710/168
Most frequent other events
Most frequent other events
EventPlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20U
HeadacheNervous system disorders3/869/17122/168
NasopharyngitisInfections and infestations6/8616/17115/168
Injection site painGeneral disorders8/8615/17115/168
Injection site haemorrhageGeneral disorders6/869/1716/168
Injection site bruisingGeneral disorders6/867/1716/168
Upper respiratory tract infectionInfections and infestations5/864/17110/168

Baseline characteristics

424 participants were included in the ITT population (86 in the Placebo; 171 in the MT10109L 24 U group and 167 participants in the MT10109L 44U group)

Age, Categorical
Age, Categorical(Participants)PlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20UTotal
<=18 years0000
Between 18 and 65 years80156157393
>=65 years6151031
Age, Continuous
Age, Continuous(years)PlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20UTotal
Mean48.6 ± 12.3247.7 ± 11.5649.1 ± 10.3748.5 ± 11.26
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20UTotal
Female71143141355
Male15282669
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20UTotal
Hispanic or Latino4111025
Not Hispanic or Latino82159157398
Unknown or Not Reported0101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboMT10109L 24U + PlaceboMT10109L 24U + MT10109L 20UTotal
American Indian or Alaska Native0123
Asian0426
Native Hawaiian or Other Pacific Islander0000
Black or African American1438
White85161159405
More than one race0112
Unknown or Not Reported0000
08

Study locations

20 sites
  • Clear Dermatology & Aesthetics Center
    Scottsdale, Arizona 85255-4134, United States
  • Art of Skin MD
    Solana Beach, California 92075-2228, United States
  • Susan H. Weinkle, MD
    Bradenton, Florida 34209-5642, United States
  • Etre Cosmetic Dermatology and Laser Center
    New Orleans, Louisiana 70130-4353, United States
  • Dermatology and Laser Surgery Center of New York
    New York, New York 10028, United States
  • Skin Search of Rochester Inc.
    Rochester, New York 14623, United States
  • M3 Wake Research Inc.
    Raleigh, North Carolina 27612-8106, United States
  • Wilmington Dermatology Center
    Wilmington, North Carolina 28403, United States
  • Aventiv Research Inc.
    Dublin, Ohio 43016, United States
  • Westlake Dermatology & Cosmetic Surgery - Westlake
    Austin, Texas 78746-4720, United States
  • DermResearch Inc.
    Austin, Texas 78759, United States
  • Dr. Jean Carruthers Cosmetic Surgery Inc.
    Vancouver, British Columbia V5Z 4E1, Canada
  • Pacific Derm
    Vancouver, British Columbia V6H 4E1, Canada
  • Dermetics Cosmetic Dermatology
    Burlington, Ontario L7N 3N2, Canada
  • Nectar Research Group Inc.
    Richmond Hill, Ontario L4B 1A5, Canada
  • Rosenpark Research
    Darmstadt, Hessen 64283, Germany
  • Hautzentrum Koln - Cologne Dermatology
    Cologne, 50996, Germany
  • Hautok and Hautok-cosmetics
    Muenchen, 80333, Germany
  • MediCorium Zentrum fuer Dermatologie und Aesthetik
    Oberursel, 61440, Germany
  • CentroDerm GmbH
    Wuppertal, 42287, Germany
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03732833
Lead sponsor
Medy-Tox
Responsible party
Sponsor
First posted
Nov 7, 2018
Start date
Nov 5, 2018
Primary completion
Mar 5, 2020
Completion
Jan 25, 2021
Results posted
Jul 17, 2023
Last update
Jul 17, 2023

Study contacts

SangMi Park
study director · Medytox Inc

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Nivobotulinumtoxina

Other studies from this sponsor

Medy-Tox →

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