Clinical trial NCT03721016: MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)
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 Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Lines
Lateral Canthal Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2018-10-26
Enrollment: 415
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 glabellar lines (GL) with or without concurrent treatment of lateral canthal lines (LCL) in participants with moderate to severe GL and 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)
timeFrame: Day 30
Secondary outcomes:
measure: The Duration of Glabellar Line (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)
timeFrame: Day 1 (first treatment) to Day 180
measure: The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)
timeFrame: Day 30
measure: 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)
timeFrame: Day 60
measure: The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS)
timeFrame: Day 30
measure: Secondary Safety: Number of Patients Who Experienced an Adverse Event (AE)
timeFrame: The time frame for AEs is after the first dose (Day 1) and up to 30 days after their last visit or study exit (Day 360 unless participant exits earlier)
measure: Mean Change From Baseline in Systolic Blood Pressure (BP)
timeFrame: Baseline to Day 360 (Study exit)
measure: Mean Change From Baseline in Diastolic Blood Pressure (BP)
timeFrame: Baseline to Day 360 (Study exit)
measure: Mean Change From Baseline in Pulse Rate
timeFrame: Baseline to Day 360 (Study exit)
measure: Mean Change From Baseline in Respiratory Rate
timeFrame: Baseline to Day 360 (Study exit)
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: 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 Center for Cosmetic Dermatologic Surgery
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: Vancouver
country: Canada
facility: Dr. Shannon Humphrey Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: Project Skin MD
state: British Columbia
city: Toronto
country: Canada
facility: Sweat Clinics of Canada
state: Ontario
city: Woodbridge
country: Canada
facility: Bertucci MedSpa Inc.
state: Ontario
city: Munich
country: Germany
facility: Studienzentrum Theatiner46
state: Bavaria
city: Kassel
country: Germany
facility: DRK-Kliniken Nordhessen
state: Hessen
city: Düsseldorf
country: Germany
facility: Privatpraxis Dr. Hilton & Partner
state: NRW
city: Berlin
country: Germany
facility: RZANY & HUND - Privatpraxis fur Dermatologie und Asthetische Medizin
city: Cheadle
country: United Kingdom
facility: Saleh Aesthetic Clinic Ltd.
state: England
city: London
country: United Kingdom
facility: Cranley Clinic
state: England
city: Basingstoke
country: United Kingdom
facility: Bermuda Practice
state: Hampshire
city: Chichester
country: United Kingdom
facility: Meyer Clinic
state: West Sussex
Study officials:
affiliation: Medytox Inc
name: SangMi Park
role: STUDY_DIRECTOR
References: