Clinical trial NCT03732833: MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar 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 With or Without Concurrent Treatment of Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lateral Canthal Lines
Glabellar Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 425
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 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.


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 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 With Photonumeric Guide (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 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 a Treatment Emergent Adverse Event (TEAEs)
timeFrame: AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose.
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 - Mean 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: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center
state: Arizona
city: Solana Beach
country: United States
facility: Art of Skin MD
state: California
city: Bradenton
country: United States
facility: Susan H. Weinkle, MD
state: Florida
city: New Orleans
country: United States
facility: Etre Cosmetic Dermatology and Laser Center
state: Louisiana
city: New York
country: United States
facility: Dermatology and Laser Surgery Center of New York
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester Inc.
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research Inc.
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Dublin
country: United States
facility: Aventiv Research Inc.
state: Ohio
city: Austin
country: United States
facility: Westlake Dermatology & Cosmetic Surgery - Westlake
state: Texas
city: Austin
country: United States
facility: DermResearch Inc.
state: Texas
city: Vancouver
country: Canada
facility: Dr. Jean Carruthers Cosmetic Surgery Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Derm
state: British Columbia
city: Burlington
country: Canada
facility: Dermetics Cosmetic Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: Nectar Research Group Inc.
state: Ontario
city: Darmstadt
country: Germany
facility: Rosenpark Research
state: Hessen
city: Cologne
country: Germany
facility: Hautzentrum Koln - Cologne Dermatology
city: Muenchen
country: Germany
facility: Hautok and Hautok-cosmetics
city: Oberursel
country: Germany
facility: MediCorium Zentrum fuer Dermatologie und Aesthetik
city: Wuppertal
country: Germany
facility: CentroDerm GmbH
Study officials:
affiliation: Medytox Inc
name: SangMi Park
role: STUDY_DIRECTOR
References: