Clinical trial NCT03785145: MT10109L in the Treatment of Lateral Canthal Lines
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lateral Canthal Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2018-12-24
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Day 30
Secondary outcomes:
measure: The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale (FWS)
timeFrame: Day 30
measure: 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)
timeFrame: Day 1 (first treatment) to Day 180
measure: 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)
timeFrame: Day 60
measure: The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)
timeFrame: Day 30
measure: Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration
timeFrame: 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)
measure: Mean Change From Baseline in Systolic Blood Pressure (BP)
timeFrame: Baseline to Day 360
measure: Mean Change From Baseline in Diastolic Blood Pressure (BP)
timeFrame: Baseline to Day 360
measure: Mean Change From Baseline in Pulse Rate
timeFrame: Baseline to Day 360
measure: Mean Change From Baseline in Respiratory Rate
timeFrame: Baseline to Day 360
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate
timeFrame: Baseline to Day 360
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
timeFrame: Baseline to Day 360
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
timeFrame: Baseline to Day 360
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
timeFrame: Baseline to Day 360
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
timeFrame: Baseline to Day 360
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
timeFrame: Baseline to Day 360
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
timeFrame: Baseline to Day 360
measure: Number of Participants With Binding and Neutralizing Antibodies
timeFrame: Baseline to Day 360
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Advanced Research Associates
state: Arizona
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Coral Gables
country: United States
facility: Skin Research Institute LLC
state: Florida
city: Metairie
country: United States
facility: Coleman Dermatologic Surgery Center
state: Louisiana
city: Hunt Valley
country: United States
facility: MD Laser, Skin, & Vein Institute
state: Maryland
city: New York
country: United States
facility: Laser Skin Surgery Center of New York
state: New York
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Arlington
country: United States
facility: SkinDC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Moscow
country: Russian Federation
facility: Moscow scientific-practical centre of dermatovenerology and cosmetology
city: Saint-Petersburg
country: Russian Federation
facility: State Budget Institution of Higher Education North-Western State Medical University named after I.I Mechnikov
city: Alderley Edge
country: United Kingdom
facility: Expert Aesthetics Ltd
state: Cheshire
city: Coatbridge
country: United Kingdom
facility: Waverley Medical Practice
state: North Lanarkshire
city: Sutton Coldfield
country: United Kingdom
facility: Medizen Clinic
state: West Midlands
Study officials:
affiliation: Medytox Inc.
name: SangMi Park
role: STUDY_DIRECTOR
References: