MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines

Glabellar Lines Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732833
• Other study ID #: MT10109L-006
• Secondary ID: 2014-005302-38
• Status: Completed
• Phase: Phase 3
• Start date: November 5, 2018
• Est. completion date: January 25, 2021

Study information

• Verified date: July 2023
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: January 25, 2021
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glabellar Lines
• Lateral Canthal Lines

Intervention

Drug:
• MT10109L
MT10109L will be injected into either the LCL, or both the LCL and GL.
• Placebo
Placebo will be injected into either the GL, or both the LCL and GL.

Locations

Country	Name	City	State
Canada	Dermetics Cosmetic Dermatology	Burlington	Ontario
Canada	Nectar Research Group Inc.	Richmond Hill	Ontario
Canada	Dr. Jean Carruthers Cosmetic Surgery Inc.	Vancouver	British Columbia
Canada	Pacific Derm	Vancouver	British Columbia
Germany	Hautzentrum Koln - Cologne Dermatology	Cologne
Germany	Rosenpark Research	Darmstadt	Hessen
Germany	Hautok and Hautok-cosmetics	Muenchen
Germany	MediCorium Zentrum fuer Dermatologie und Aesthetik	Oberursel
Germany	CentroDerm GmbH	Wuppertal
United States	DermResearch Inc.	Austin	Texas
United States	Westlake Dermatology & Cosmetic Surgery - Westlake	Austin	Texas
United States	Susan H. Weinkle, MD	Bradenton	Florida
United States	Aventiv Research Inc.	Dublin	Ohio
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	M3 Wake Research Inc.	Raleigh	North Carolina
United States	Skin Search of Rochester Inc.	Rochester	New York
United States	Clear Dermatology & Aesthetics Center	Scottsdale	Arizona
United States	Art of Skin MD	Solana Beach	California
United States	Wilmington Dermatology Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The outcome measured is the percentage of participants who had a =2-grade improvement from baseline LCL severity at maximum smile according to investigator and participant FWS ratings at Day 30.; Both the INVESTIGATOR AND PARTICIPANT evaluate the LCL severity using a 4-grade scale (0 to 3) where 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.	Day 30
Secondary	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)	The outcome here only considers the INVESTIGATOR assessments (excludes the participant assessment). The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. A Responder was defined as one achieving a =2-grade improvement from baseline at maximum smile at Day 30.	Day 30
Secondary	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	The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.	Day 1 (first treatment) to Day 180
Secondary	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)	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.	Day 60
Secondary	The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)	The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.; 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. The outcome measured here is the proportion of participants who achieved a =1-grade improvement from baseline LCL severity at rest based on investigator FWS rating.	Day 30
Secondary	Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs)	This section focuses primarily on TEAEs, i.e., AEs that started or worsened after the first dose of study intervention and within 30 days after the last dose. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.	AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose.
Secondary	Mean Change From Baseline in Systolic Blood Pressure (BP)	The outcome reported here is the mean change in Systolic BP from baseline to study exit.	Baseline to Day 360
Secondary	Mean Change From Baseline in Diastolic Blood Pressure (BP)	The outcome reported here is the mean change in Diastolic BP from baseline to study exit.	Baseline to Day 360
Secondary	Mean Change From Baseline in Pulse Rate	The outcome reported here is the mean change in Pulse Rate from baseline to study exit.	Baseline to Day 360
Secondary	Mean Change From Baseline in Respiratory Rate	The outcome reported here is the mean change in Respiratory Rate from baseline to study exit.	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate	The outcome reported here is a mean change in mean heart rate from baseline to study exit.	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval	The outcome reported here is a mean change in PR interval from baseline to study exit.	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration	The outcome reported here is a mean change in QRS duration from baseline to study exit.	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval	The outcome reported here is a mean change in QT interval from baseline to study exit.	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval	The outcome reported here is a mean change in QTcB interval from baseline to study exit.	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval	The outcome reported here is a mean change in QTcF interval from baseline to study exit.	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval	The outcome reported here is a mean change in RR interval from baseline to study exit.	Baseline to Day 360
Secondary	Number of Participants With Binding and Neutralizing Antibodies	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.	Baseline to Day 360