MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)

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 Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721016
• Other study ID #: MT10109L-005
• Secondary ID: 2014-005301-21
• Status: Completed
• Phase: Phase 3
• Start date: October 26, 2018
• Est. completion date: January 22, 2021

Study information

• Verified date: April 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 glabellar lines (GL) with or without concurrent treatment of lateral canthal lines (LCL) in participants with moderate to severe GL and LCL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: January 22, 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
MT10109Lwill be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.
• Placebo
Placebo will be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.

Locations

Country	Name	City	State
Canada	Sweat Clinics of Canada	Toronto	Ontario
Canada	Dr. Shannon Humphrey Inc.	Vancouver	British Columbia
Canada	Project Skin MD	Vancouver	British Columbia
Canada	Bertucci MedSpa Inc.	Woodbridge	Ontario
Germany	RZANY & HUND - Privatpraxis fur Dermatologie und Asthetische Medizin	Berlin
Germany	Privatpraxis Dr. Hilton & Partner	Düsseldorf	NRW
Germany	DRK-Kliniken Nordhessen	Kassel	Hessen
Germany	Studienzentrum Theatiner46	Munich	Bavaria
United Kingdom	Bermuda Practice	Basingstoke	Hampshire
United Kingdom	Saleh Aesthetic Clinic Ltd.	Cheadle	England
United Kingdom	Meyer Clinic	Chichester	West Sussex
United Kingdom	Cranley Clinic	London	England
United States	SkinDC	Arlington	Virginia
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	Skin Research Institute LLC	Coral Gables	Florida
United States	Advanced Research Associates	Glendale	Arizona
United States	MD Laser, Skin, & Vein Institute	Hunt Valley	Maryland
United States	Coleman Center for Cosmetic Dermatologic Surgery	Metairie	Louisiana
United States	Laser & Skin Surgery Center of New York	New York	New York
United States	Eye Research Foundation	Newport Beach	California
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Countries where clinical trial is conducted

United States,  Canada,  Germany,  United Kingdom, 

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)	The outcome measured is 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.; The investigator and participant evaluates the participant's GL severity using a Facial Wrinkle Scale With Photonumeric Guide (FWS) at maximum frown on Day 30. The scale ranges from (0 to 3) where 0=none and 3 = severe.	Day 30
Secondary	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)	The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (ie, return to moderate or severe GL severity at maximum frown using the FWS).	Day 1 (first treatment) to Day 180
Secondary	The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)	The percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a =2-grade Improvement from Baseline at Maximum Frown at Day 30.; The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.	Day 30
Secondary	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)	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 Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS)	The outcome was measured 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 investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.	Day 30
Secondary	Secondary Safety: Number of Patients Who Experienced an Adverse Event (AE)	This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.	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)
Secondary	Mean Change From Baseline in Systolic Blood Pressure (BP)	Changes in vital signs: Systolic BP	Baseline to Day 360 (Study exit)
Secondary	Mean Change From Baseline in Diastolic Blood Pressure (BP)	Changes in vital signs: Diastolic BP	Baseline to Day 360 (Study exit)
Secondary	Mean Change From Baseline in Pulse Rate	Changes in vital signs: Pulse Rate	Baseline to Day 360 (Study exit)
Secondary	Mean Change From Baseline in Respiratory Rate	Changes in vital signs: Respiratory Rate	Baseline to Day 360 (Study exit)
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate	Change from baseline for ECG safety population - Heart Rate	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval	Change from baseline for ECG safety population - PR Interval	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration	Change from baseline for ECG safety population - QRS duration	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval	Change from baseline for ECG safety population - QT interval	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval	Change from baseline for ECG safety population - QTcB interval	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval	Change from baseline for ECG safety population - QTcF interval	Baseline to Day 360
Secondary	Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval	Change from baseline for ECG safety population - RR interval	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.	Day 360