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Completed

NCT Number: NCT03785145

MT10109L in the Treatment of Lateral Canthal Lines

To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines (LCL) in participants with moderate to severe LCL.

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Key information

Conditions

Lateral Canthal Lines

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Moscow scientific-practical centre of dermatovenerology and cosmetology, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

MT10109L

Drug

MT10109L will be injected into the LCL.

Other names: NivobotulinumtoxinA

Placebo

Drug

Placebo will be injected into the LCL.

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 Lateral Canthal Lines (LCL) Severity at Maximum Smile at Day 30

    Time frame: Day 30

    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, 1=mild, 2=moderate and 3=severe

Secondary outcomes

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

    Time frame: Day 30

    The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a≥2-grade Improvement from Baseline at Maximum Smile at Day 30.

    The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none, 1=mild, 2=moderate and 3=severe.

  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 Facial Wrinkle Scale (FWS)

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

    The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none, 1=mild, 2=moderate and 3 = severe using the Facial Wrinkle Scale (FWS). The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe LCL severity at maximum smile using the FWS).

  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)

    Time frame: Day 60

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

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

    Time frame: Day 30

    The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none, 1=mild, 2=moderate and 3=severe.

    The outcome was measured among participants who were at least mild at rest at baseline, where a responder was defined as achieving a >=1-grade improvement from baseline at Day 30.

  5. Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration

    Time frame: AEs that started or worsen after the first dose of study intervention and up to 30 days after their last visit or study exit (Day 360 or early exit)

    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. TEAE's are recorded by the PI and their study team from observations made after treatment administration. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs. All safety analyses were performed with participants analyzed by their actual treatment or regimen received.

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

    Time frame: Baseline to Day 360

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

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

    Time frame: Baseline to Day 360

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

  8. Mean Change From Baseline in Pulse Rate

    Time frame: Baseline to Day 360

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

  9. Mean Change From Baseline in Respiratory Rate

    Time frame: Baseline to Day 360

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

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

    Time frame: Baseline to Day 360

    The outcome reported here is a mean change in mean heart rate from baseline to studyexit

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

    Time frame: Baseline to Day 360

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

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

    Time frame: Baseline to Day 360

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

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

    Time frame: Baseline to Day 360

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

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

    Time frame: Baseline to Day 360

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

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

    Time frame: Baseline to Day 360

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

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

    Time frame: Baseline to Day 360

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

  17. Number of Participants With Binding and Neutralizing Antibodies

    Time frame: Baseline to Day 360

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

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Lateral Canthal Lines

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Dec 24, 2018
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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