MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)
- Conditions
- Glabellar LinesLateral Canthal Lines
- Interventions
- Drug: Placebo
- Registration Number
- NCT03721016
- Lead Sponsor
- Medy-Tox
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 415
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MT10109L Dose 1 + Placebo Placebo 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. Placebo Placebo 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. MT10109L Dose 1 + Placebo MT10109L 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. MT10109L Dose 1 + MT10109L Dose 2 MT10109L 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.
- Primary Outcome Measures
Name Time Method The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) Day 30 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.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval Baseline to Day 360 Change from baseline for ECG safety population - QTcF interval
Mean Change From Baseline in Systolic Blood Pressure (BP) Baseline to Day 360 (Study exit) Changes in vital signs: Systolic BP
Mean Change From Baseline in Respiratory Rate Baseline to Day 360 (Study exit) Changes in vital signs: Respiratory Rate
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate Baseline to Day 360 Change from baseline for ECG safety population - Heart Rate
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) 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 (ie, return to moderate or severe GL severity at maximum frown using the FWS).
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS) 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.
The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS) 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
The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval Baseline to Day 360 Change from baseline for ECG safety population - PR Interval
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) 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.
Mean Change From Baseline in Diastolic Blood Pressure (BP) Baseline to Day 360 (Study exit) Changes in vital signs: Diastolic BP
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval Baseline to Day 360 Change from baseline for ECG safety population - QT interval
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval Baseline to Day 360 Change from baseline for ECG safety population - QTcB interval
Number of Participants With Binding and Neutralizing Antibodies 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.
Secondary Safety: Number of Patients Who Experienced an Adverse Event (AE) 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) 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.
Mean Change From Baseline in Pulse Rate Baseline to Day 360 (Study exit) Changes in vital signs: Pulse Rate
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration Baseline to Day 360 Change from baseline for ECG safety population - QRS duration
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval Baseline to Day 360 Change from baseline for ECG safety population - RR interval
Trial Locations
- Locations (21)
Dr. Shannon Humphrey Inc.
🇨🇦Vancouver, British Columbia, Canada
Coleman Center for Cosmetic Dermatologic Surgery
🇺🇸Metairie, Louisiana, United States
Bellaire Dermatology Associates
🇺🇸Bellaire, Texas, United States
Project Skin MD
🇨🇦Vancouver, British Columbia, Canada
Bertucci MedSpa Inc.
🇨🇦Woodbridge, Ontario, Canada
Studienzentrum Theatiner46
🇩🇪Munich, Bavaria, Germany
RZANY & HUND - Privatpraxis fur Dermatologie und Asthetische Medizin
🇩🇪Berlin, Germany
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Skin Research Institute LLC
🇺🇸Coral Gables, Florida, United States
Advanced Research Associates
🇺🇸Glendale, Arizona, United States
SkinDC
🇺🇸Arlington, Virginia, United States
Laser & Skin Surgery Center of New York
🇺🇸New York, New York, United States
MD Laser, Skin, & Vein Institute
🇺🇸Hunt Valley, Maryland, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Sweat Clinics of Canada
🇨🇦Toronto, Ontario, Canada
DRK-Kliniken Nordhessen
🇩🇪Kassel, Hessen, Germany
Privatpraxis Dr. Hilton & Partner
🇩🇪Düsseldorf, NRW, Germany
Saleh Aesthetic Clinic Ltd.
🇬🇧Cheadle, England, United Kingdom
Cranley Clinic
🇬🇧London, England, United Kingdom
Bermuda Practice
🇬🇧Basingstoke, Hampshire, United Kingdom
Meyer Clinic
🇬🇧Chichester, West Sussex, United Kingdom