Clinical trial NCT04157686: MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Lines
Lateral Canthal Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-11-08
Enrollment: 957
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Who Experienced Any Adverse Event (AE)
timeFrame: Baseline to Day 720 or Study Exit
measure: Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)
timeFrame: Baseline to Day 720 or Study exit
measure: Mean Change From Baseline in Pulse Rate (Beats Per Minute)
timeFrame: Baseline to Day 720 or Study Exit
measure: Mean Change From Baseline in Systolic Blood Pressure (mm Hg)
timeFrame: Baseline to Day 720 or Study Exit
measure: Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)
timeFrame: Baseline to Day 720 or Study Exit
measure: Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)
timeFrame: Baseline to Day 720 or Study Exit
measure: Number of Participants With Binding and Neutralizing Antibodies
timeFrame: Baseline to Day 720 or Study Exit
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center
state: Arizona
city: Newport Beach
country: United States
facility: The Eye Research Foundation
state: California
city: Solana Beach
country: United States
facility: Art of Skin MD
state: California
city: Bradenton
country: United States
facility: Susan H. Weinkle
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute
state: Florida
city: Metairie
country: United States
facility: Coleman Center For Cosmetic Dermatologic Surgery
state: Louisiana
city: New Orleans
country: United States
facility: Etre Cosmetic Dermatology and Laser Center
state: Louisiana
city: Hunt Valley
country: United States
facility: MD Laser Skin & Vein
state: Maryland
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York
state: New York
city: Rochester
country: United States
facility: Skin Search of Rochester Inc.
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research Inc.
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Dublin
country: United States
facility: Aventiv Research Dublin
state: Ohio
city: Austin
country: United States
facility: Westlake Dermatology & Cosmetic Surgery - Westlake
state: Texas
city: Austin
country: United States
facility: DermResearch Inc.
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology
state: Texas
city: Arlington
country: United States
facility: SkinDC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Jette
country: Belgium
facility: UZ Brussel
state: Bruxelles-Capitale
city: Sint-Truiden
country: Belgium
facility: Medical Skincare
state: Limburg
city: Vancouver
country: Canada
facility: Dr. Shannon Humphrey Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: Project Skin MD LTD
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Derm
state: British Columbia
city: Toronto
country: Canada
facility: Sweat Clinics of Canada
state: Ontarion
city: Burlington
country: Canada
facility: Dermetics Cosmetic Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Center For Dermatology
state: Ontario
city: Darmstadt
country: Germany
facility: Rosenpark Research
city: Duesseldorf
country: Germany
facility: Privatpraxis Dr. Hilton & Partner
city: Muenchen
country: Germany
facility: Hautok and Hautok-cosmetics
city: Muenchen
country: Germany
facility: Studienzentrum Theatiner46
city: Oberursel
country: Germany
facility: MediCorium Zentrum fuer Dermatologie und Aesthetik
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Moscow
country: Russian Federation
facility: Medical Center Capital - Zdorovie LLC
city: Moscow
country: Russian Federation
facility: Center dermatovenereology and cosmetology
city: Saint-Petersburg
country: Russian Federation
facility: State Budget Institution of Higher Education North
city: Chichester
country: United Kingdom
facility: Meyer Clinic
city: Glasgow
country: United Kingdom
facility: NHS Lanarkshire
city: Sutton Coldfield
country: United Kingdom
facility: MediZen Premier Aesthetic Clinic
Study officials:
affiliation: Medytox Inc.
name: SangMi Park
role: STUDY_DIRECTOR
References: