MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)

Glabellar Lines Clinical Trial

Official title:

A Multicenter, Long-term, Open-label Study to Evaluate the Safety of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines and Lateral Canthal Lines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04157686
• Other study ID #: MT10109L-004
• Secondary ID: 2014-005303-24
• Status: Completed
• Phase: Phase 3
• Start date: October 23, 2019
• Est. completion date: February 16, 2023

Study information

• Verified date: March 2024
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.

Description:

Study MT10109L-004 is an open-label extension involving participants from studies MT10109L-001 (NCT03795922), -002 (NCT03785145), -005 (NCT03721016), and -006 (NCT03732833) (referred to as Lead-In studies). The objective is to evaluate long term safety of MT10109L. Participants will include those who completed the global lead-in studies and meet the eligibility criteria for entering this open-label extension study. Participants who meet retreatment criteria will receive MT10109L administered in the same treatment area(s) with the same number of injections and injection sites as in their lead-in studies. The safety and efficacy data from the lead-in and this open-label extension will be summarized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 957
• Est. completion date: February 16, 2023
• Est. primary completion date: February 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Completion of lead-in Phase 3 study;
• 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;
• Known allergy or sensitivity to any of the components of the study interventions, or any materials used in the study procedures;
• 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 Dose 1
MT10109L Dose 1 will be injected into the GL area
• MT10109L Dose 2
MT10109L Dose 2 will be injected into the LCL area
• MT10109L Dose 1 + Dose 2
MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Bruxelles-Capitale
Belgium	Medical Skincare	Sint-Truiden	Limburg
Canada	Dermetics Cosmetic Dermatology	Burlington	Ontario
Canada	The Center For Dermatology	Richmond Hill	Ontario
Canada	Sweat Clinics of Canada	Toronto	Ontarion
Canada	Dr. Shannon Humphrey Inc.	Vancouver	British Columbia
Canada	Pacific Derm	Vancouver	British Columbia
Canada	Project Skin MD LTD	Vancouver	British Columbia
Germany	Rosenpark Research	Darmstadt
Germany	Privatpraxis Dr. Hilton & Partner	Duesseldorf
Germany	Hautok and Hautok-cosmetics	Muenchen
Germany	Studienzentrum Theatiner46	Muenchen
Germany	MediCorium Zentrum fuer Dermatologie und Aesthetik	Oberursel
Russian Federation	Kazan State Medical University	Kazan
Russian Federation	Center dermatovenereology and cosmetology	Moscow
Russian Federation	Medical Center Capital - Zdorovie LLC	Moscow
Russian Federation	State Budget Institution of Higher Education North	Saint-Petersburg
United Kingdom	Meyer Clinic	Chichester
United Kingdom	NHS Lanarkshire	Glasgow
United Kingdom	MediZen Premier Aesthetic Clinic	Sutton Coldfield
United States	SkinDC	Arlington	Virginia
United States	DermResearch Inc.	Austin	Texas
United States	Westlake Dermatology & Cosmetic Surgery - Westlake	Austin	Texas
United States	Bellaire Dermatology	Bellaire	Texas
United States	Susan H. Weinkle	Bradenton	Florida
United States	Skin Research Institute	Coral Gables	Florida
United States	Aventiv Research Dublin	Dublin	Ohio
United States	MD Laser Skin & Vein	Hunt Valley	Maryland
United States	Coleman Center For Cosmetic Dermatologic Surgery	Metairie	Louisiana
United States	Etre Cosmetic Dermatology and Laser Center	New Orleans	Louisiana
United States	Laser & Skin Surgery Center of New York	New York	New York
United States	The Eye Research Foundation	Newport Beach	California
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
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,  Belgium,  Canada,  Germany,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who experienced an adverse event		Baseline to Day 720
Primary	Mean change from baseline in pulse rate (beats per minute)		Baseline to Day 720
Primary	Mean change from baseline in blood pressure (mm Hg)		Baseline to Day 720
Primary	Mean change from baseline in respiratory rate (breaths per minute)		Baseline to Day 720
Primary	Number of participants with binding and neutralizing antibodies		Baseline to Day 720