MT10109L in the Treatment of Glabellar Lines
- Registration Number
- NCT03795922
- Lead Sponsor
- Medy-Tox
- Brief Summary
To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MT10109L MT10109L MT10109L will be injected into the GL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. Placebo Placebo Placebo will be injected into the GL: initial double-blind treatment on Day 1.
- 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 Glabellar Lines (GL) Severity at Maximum Frown 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 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 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 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
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.
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) 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).
Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP) Baseline to Study exit (Day 360 or early exit) Change from baseline at study exit.
Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP) Baseline to Study exit (Day 360 or early exit) Change from baseline at study exit.
Mean Change From Baseline in Vital Signs - Pulse Rate Baseline to Study exit (Day 360 or early exit) Change from baseline at study exit.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate Baseline to Study Exit (Day 360 or early exit) Change from baseline at study exit.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval Baseline to Study Exit (Day 360 or early exit) Change from baseline at study exit.
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 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.
Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration 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.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval Baseline to Study Exit (Day 360 or early exit) Change from baseline at study exit.
Mean Change From Baseline in Vital Signs - Respiratory Rate Baseline to Study exit (Day 360 or early exit) Change from baseline at study exit.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration Baseline to Study Exit (Day 360 or early exit) Change from baseline at study exit.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval Baseline to Study Exit (Day 360 or early exit) Change from baseline at study exit.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval Baseline to Study Exit (Day 360 or early exit) Change from baseline at study exit.
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval Baseline to Study Exit (Day 360 or early exit) Change from baseline at study exit.
Number of Participants With Binding and Neutralizing Antibodies 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.
Trial Locations
- Locations (15)
Investigate MD
🇺🇸Scottsdale, Arizona, United States
Weinkle Dermatology
🇺🇸Bradenton, Florida, United States
Etre, Cosmetic Dermatology and Laser Center
🇺🇸New Orleans, Louisiana, United States
Dermatology and Laser Surgery Center of New York
🇺🇸New York, New York, United States
CHU Liege
🇧🇪Liege, Belgium
Kazan State Medical University
🇷🇺Kazan, Tatarstan Republic, Russian Federation
Art of Skin MD
🇺🇸Solana Beach, California, United States
SkinSearch of Rochester, Inc.
🇺🇸Rochester, New York, United States
M3 Wake Research, Inc.
🇺🇸Raleigh, North Carolina, United States
Westlake Dermatology & Cosmetic Surgery
🇺🇸Austin, Texas, United States
Aventiv Research, Inc.
🇺🇸Dublin, Ohio, United States
Centre de la Fontaine
🇧🇪Loverval, Hainaut, Belgium
Medical Centre Capital-Zdorovie
🇷🇺Moscow, Russian Federation
Universitair Ziekenhuis Brussel
🇧🇪Brussels, Belgium
Medical Skin Care
🇧🇪Sint-Truiden, Limburg, Belgium