Clinical trial NCT03795922: MT10109L in the 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 Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-01-08
Enrollment: 234
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 glabellar lines (GL) in participants with moderate to severe 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 Glabellar Lines (GL) Severity at Maximum Frown at Day 30
timeFrame: Day 30
Secondary outcomes:
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 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)
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 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: Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration
timeFrame: 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).
measure: Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)
timeFrame: Baseline to Study exit (Day 360 or early exit)
measure: Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)
timeFrame: Baseline to Study exit (Day 360 or early exit)
measure: Mean Change From Baseline in Vital Signs - Pulse Rate
timeFrame: Baseline to Study exit (Day 360 or early exit)
measure: Mean Change From Baseline in Vital Signs - Respiratory Rate
timeFrame: Baseline to Study exit (Day 360 or early exit)
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate
timeFrame: Baseline to Study Exit (Day 360 or early exit)
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
timeFrame: Baseline to Study Exit (Day 360 or early exit)
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
timeFrame: Baseline to Study Exit (Day 360 or early exit)
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
timeFrame: Baseline to Study Exit (Day 360 or early exit)
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
timeFrame: Baseline to Study Exit (Day 360 or early exit)
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
timeFrame: Baseline to Study Exit (Day 360 or early exit)
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
timeFrame: Baseline to Study Exit (Day 360 or early exit)
measure: Number of Participants With Binding and Neutralizing Antibodies
timeFrame: Up to Study Exit (Day 360 or early exit)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigate MD
state: Arizona
city: Solana Beach
country: United States
facility: Art of Skin MD
state: California
city: Bradenton
country: United States
facility: Weinkle Dermatology
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: SkinSearch of Rochester, Inc.
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Dublin
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Austin
country: United States
facility: Westlake Dermatology & Cosmetic Surgery
state: Texas
city: Loverval
country: Belgium
facility: Centre de la Fontaine
state: Hainaut
city: Sint-Truiden
country: Belgium
facility: Medical Skin Care
state: Limburg
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Liege
country: Belgium
facility: CHU Liege
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
state: Tatarstan Republic
city: Moscow
country: Russian Federation
facility: Medical Centre Capital-Zdorovie
Study officials:
affiliation: Medytox Inc.
name: SangMi Park
role: STUDY_DIRECTOR
References: