MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines
- Conditions
- Lateral Canthal LinesGlabellar Lines
- Interventions
- Drug: Placebo
- Registration Number
- NCT03732833
- Lead Sponsor
- Medy-Tox
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 425
-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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. MT10109L Dose 1 + Placebo MT10109L 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. MT10109L Dose 1 + Placebo 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. MT10109L Dose 1 + MT10109L Dose 2 MT10109L 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.
- 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) According to INVESTIGATOR AND PARTICIPANT Assessments of LCL Severity at Maximum Smile at Day 30 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.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Respiratory Rate Baseline to Day 360 The outcome reported here is the mean change in Respiratory Rate from baseline to study exit.
Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs) AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose. 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.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration Baseline to Day 360 The outcome reported here is a mean change in QRS duration from baseline to study exit.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval Baseline to Day 360 The outcome reported here is a mean change in QTcF interval from baseline to study exit.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval Baseline to Day 360 The outcome reported here is a mean change in RR interval from baseline to study exit.
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) Day 30 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.
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 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 and 3 = severe.
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) 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.
The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS) Day 30 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.Mean Change From Baseline in Systolic Blood Pressure (BP) Baseline to Day 360 The outcome reported here is the mean change in Systolic BP from baseline to study exit.
Mean Change From Baseline in Diastolic Blood Pressure (BP) Baseline to Day 360 The outcome reported here is the mean change in Diastolic BP from baseline to study exit.
Mean Change From Baseline in Pulse Rate Baseline to Day 360 The outcome reported here is the mean change in Pulse Rate from baseline to study exit.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate Baseline to Day 360 The outcome reported here is a mean change in mean heart rate from baseline to study exit.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval Baseline to Day 360 The outcome reported here is a mean change in PR interval from baseline to study exit.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval Baseline to Day 360 The outcome reported here is a mean change in QTcB interval from baseline to study exit.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval Baseline to Day 360 The outcome reported here is a mean change in QT interval from baseline to study exit.
Number of Participants With Binding and Neutralizing Antibodies 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.
Trial Locations
- Locations (20)
M3 Wake Research Inc.
🇺🇸Raleigh, North Carolina, United States
Art of Skin MD
🇺🇸Solana Beach, California, United States
Wilmington Dermatology Center
🇺🇸Wilmington, North Carolina, United States
Dermetics Cosmetic Dermatology
🇨🇦Burlington, Ontario, Canada
MediCorium Zentrum fuer Dermatologie und Aesthetik
🇩🇪Oberursel, Germany
Rosenpark Research
🇩🇪Darmstadt, Hessen, Germany
Etre Cosmetic Dermatology and Laser Center
🇺🇸New Orleans, Louisiana, United States
Dr. Jean Carruthers Cosmetic Surgery Inc.
🇨🇦Vancouver, British Columbia, Canada
Pacific Derm
🇨🇦Vancouver, British Columbia, Canada
Susan H. Weinkle, MD
🇺🇸Bradenton, Florida, United States
Clear Dermatology & Aesthetics Center
🇺🇸Scottsdale, Arizona, United States
Nectar Research Group Inc.
🇨🇦Richmond Hill, Ontario, Canada
Hautzentrum Koln - Cologne Dermatology
🇩🇪Cologne, Germany
Dermatology and Laser Surgery Center of New York
🇺🇸New York, New York, United States
Skin Search of Rochester Inc.
🇺🇸Rochester, New York, United States
Aventiv Research Inc.
🇺🇸Dublin, Ohio, United States
Westlake Dermatology & Cosmetic Surgery - Westlake
🇺🇸Austin, Texas, United States
DermResearch Inc.
🇺🇸Austin, Texas, United States
CentroDerm GmbH
🇩🇪Wuppertal, Germany
Hautok and Hautok-cosmetics
🇩🇪Muenchen, Germany