Skip to main content
OpenTrials
Completed

NCT Number: NCT03795922

MT10109L in the Treatment of Glabellar Lines

To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glabellar Lines

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre de la Fontaine, Loverval, Hainaut, Belgium

Loading trial locations.

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 GL.

Other names: NivobotulinumtoxinA

Placebo

Drug

Placebo will be injected into the GL.

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 Glabellar Lines (GL) Severity at Maximum Frown 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 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.

Secondary outcomes

  1. The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)

    Time frame: Day 30

    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

  2. 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)

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

    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).

  3. 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)

    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 Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS).

    Time frame: Day 30

    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.

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

    Time frame: 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).

    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.

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

    Time frame: Baseline to Study exit (Day 360 or early exit)

    Change from baseline at study exit.

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

    Time frame: Baseline to Study exit (Day 360 or early exit)

    Change from baseline at study exit.

  8. Mean Change From Baseline in Vital Signs - Pulse Rate

    Time frame: Baseline to Study exit (Day 360 or early exit)

    Change from baseline at study exit.

  9. Mean Change From Baseline in Vital Signs - Respiratory Rate

    Time frame: Baseline to Study exit (Day 360 or early exit)

    Change from baseline at study exit.

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

    Time frame: Baseline to Study Exit (Day 360 or early exit)

    Change from baseline at study exit.

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

    Time frame: Baseline to Study Exit (Day 360 or early exit)

    Change from baseline at study exit.

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

    Time frame: Baseline to Study Exit (Day 360 or early exit)

    Change from baseline at study exit.

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

    Time frame: Baseline to Study Exit (Day 360 or early exit)

    Change from baseline at study exit.

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

    Time frame: Baseline to Study Exit (Day 360 or early exit)

    Change from baseline at study exit.

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

    Time frame: Baseline to Study Exit (Day 360 or early exit)

    Change from baseline at study exit.

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

    Time frame: Baseline to Study Exit (Day 360 or early exit)

    Change from baseline at study exit.

  17. Number of Participants With Binding and Neutralizing Antibodies

    Time frame: Up to Study Exit (Day 360 or early exit)

    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 Glabellar Lines

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jan 8, 2019
Registry last updated
Jul 27, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.