MT10109L in the Treatment of Lateral Canthal Lines
- Registration Number
- NCT03785145
- Lead Sponsor
- Medy-Tox
- Brief Summary
To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines (LCL) in participants with moderate to severe LCL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 235
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo will be injected into the LCL: initial double-blind treatment on Day 1. MT10109L MT10109L MT10109L will be injected into the LCL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions 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 Lateral Canthal Lines (LCL) Severity at Maximum Smile at Day 30 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 Outcome Measures
Name Time Method 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 Respiratory Rate Baseline to Day 360 The outcome reported here is the mean change in Respiratory Rate from baseline to study exit.
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, 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.Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate Baseline to Day 360 The outcome reported here is a mean change in mean heart rate from baseline to studyexit
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
The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale (FWS) 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.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) 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).
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.
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 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 - QT Interval Baseline to Day 360 The outcome reported here is a mean change in QT Interval 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
Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration 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.
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 - 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 - RR Interval Baseline to Day 360 The outcome reported here is a mean change in RR 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 (14)
Advanced Research Associates
🇺🇸Glendale, Arizona, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Skin Research Institute LLC
🇺🇸Coral Gables, Florida, United States
Coleman Dermatologic Surgery Center
🇺🇸Metairie, Louisiana, United States
MD Laser, Skin, & Vein Institute
🇺🇸Hunt Valley, Maryland, United States
Laser Skin Surgery Center of New York
🇺🇸New York, New York, United States
Bellaire Dermatology Associates
🇺🇸Bellaire, Texas, United States
SkinDC
🇺🇸Arlington, Virginia, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Moscow scientific-practical centre of dermatovenerology and cosmetology
🇷🇺Moscow, Russian Federation
Scroll for more (4 remaining)Advanced Research Associates🇺🇸Glendale, Arizona, United States