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

Phase 3

Completed

Conditions: Glabellar Lines
Lateral Canthal Lines

Interventions: Drug: MT10109L Dose 1
Drug: MT10109L Dose 2
Drug: MT10109L Dose 1 + Dose 2

Registration Number: NCT04157686

Lead Sponsor: Medy-Tox

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 957

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo/MT10109L Dose 1	MT10109L Dose 1	The participant pool in this arm are from the MT10109L-001 lead-in study (NCT03795922), who received Placebo in period 1 and MT10109L Dose 1 in period 2. Eligible participants from this study continue receiving Dose 1 in the open-label MT10109L-004 study
Placebo/MT10109L Dose 2	MT10109L Dose 2	The participant pool in this arm are from the MT10109L-002 lead-in study (NCT03785145), who received Placebo in period 1 and MT10109L Dose 2 in period 2. Eligible participants from this study continue receiving Dose 2 in the open-label MT10109L-004 study.
Placebo/MT10109L Dose 1 + Dose 2	MT10109L Dose 1 + Dose 2	The participant pool in this arm are from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received Placebo in periods 1 \& 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1/Dose 1	MT10109L Dose 1	The participant pool in this arm are from the MT10109L-001 lead-in study (NCT03795922), who received MT10109L Dose 1 each in period 1 and period 2. Eligible participants from this study continue receiving Dose 1 in the open-label MT10109L-004 study.
MT10109L Dose 2/Dose 2	MT10109L Dose 2	The participant pool in this arm are from the MT10109L-002 lead-in study (NCT03785145), who received MT10109L Dose 2 each in period 1 and period 2. Eligible participants from this study continue receiving Dose 2 in the open-label MT10109L-004 study.
MT10109L Dose 1/Dose 1+2	MT10109L Dose 1 + Dose 2	The participant pool in this arm are from the from MT10109L-005 lead-in study (NCT03721016), who received MT10109L Dose 1 in periods 1 and 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 2/Dose 1+2	MT10109L Dose 1 + Dose 2	The participant pool in this arm are from the MT10109L-006 lead-in study (NCT03732833), who received MT10109L Dose 2 in periods 1 and 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.
MT10109L Dose 1+2/Dose 1+2	MT10109L Dose 1 + Dose 2	The participant pool in this arm are from the MT10109L-005 (NCT03721016) and MT10109L-006 (NCT03732833) lead-in studies, who received MT10109L Dose 1 into GL and Dose 2 into LCL in periods 1 \& 2. Eligible participants from this study receives Dose 1 into the GL area and Dose 2 into the LCL area in the open-label MT10109L-004 study.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Any Adverse Event (AE)	Baseline to Day 720 or Study Exit	The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit.
Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)	Baseline to Day 720 or Study exit	This section focuses primarily on Treatment-Related (Study drug or procedure) Adverse Events(TEAEs). TEAEs are AEs with onset date on or after first dose of study intervention (placebo or MT10109L) in the pivotal study and ≤ 30 days after the study exit visit in the extension study.
Mean Change From Baseline in Systolic Blood Pressure (mm Hg)	Baseline to Day 720 or Study Exit	The outcome reported here is the mean change in Systolic BP from baseline to study exit.
Mean Change From Baseline in Pulse Rate (Beats Per Minute)	Baseline to Day 720 or Study Exit	The outcome reported here is the mean change in pulse rate from baseline to study exit.
Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)	Baseline to Day 720 or Study Exit	The outcome reported here is the mean change in Diastolic BP from baseline to study exit.
Number of Participants With Binding and Neutralizing Antibodies	Baseline to Day 720 or Study Exit	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.
Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)	Baseline to Day 720 or Study Exit	The outcome reported here is the mean change in respiratory rate from baseline to study exit.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (38): Medical Skincare
🇧🇪
Sint-Truiden, Limburg, Belgium
Project Skin MD LTD
🇨🇦
Vancouver, British Columbia, Canada
Medical Center Capital - Zdorovie LLC
🇷🇺
Moscow, Russian Federation
Pacific Derm
🇨🇦
Vancouver, British Columbia, Canada
Art of Skin MD
🇺🇸
Solana Beach, California, United States
The Eye Research Foundation
🇺🇸
Newport Beach, California, United States
Susan H. Weinkle
🇺🇸
Bradenton, Florida, United States
M3 Wake Research Inc.
🇺🇸
Raleigh, North Carolina, United States
Virginia Clinical Research, Inc.
🇺🇸
Norfolk, Virginia, United States
Dr. Shannon Humphrey Inc.
🇨🇦
Vancouver, British Columbia, Canada
Bellaire Dermatology
🇺🇸
Bellaire, Texas, United States
Privatpraxis Dr. Hilton & Partner
🇩🇪
Duesseldorf, Germany
Kazan State Medical University
🇷🇺
Kazan, Russian Federation
Studienzentrum Theatiner46
🇩🇪
Muenchen, Germany
MediCorium Zentrum fuer Dermatologie und Aesthetik
🇩🇪
Oberursel, Germany
Hautok and Hautok-cosmetics
🇩🇪
Muenchen, Germany
Center dermatovenereology and cosmetology
🇷🇺
Moscow, Russian Federation
Meyer Clinic
🇬🇧
Chichester, United Kingdom
Clear Dermatology & Aesthetics Center
🇺🇸
Scottsdale, Arizona, United States
Aventiv Research Dublin
🇺🇸
Dublin, Ohio, United States
Wilmington Dermatology Center
🇺🇸
Wilmington, North Carolina, United States
Skin Research Institute
🇺🇸
Coral Gables, Florida, 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
Skin Search of Rochester Inc.
🇺🇸
Rochester, New York, United States
MD Laser Skin & Vein
🇺🇸
Hunt Valley, Maryland, United States
SkinDC
🇺🇸
Arlington, Virginia, United States
UZ Brussel
🇧🇪
Jette, Bruxelles-Capitale, Belgium
Sweat Clinics of Canada
🇨🇦
Toronto, Ontarion, Canada
Dermetics Cosmetic Dermatology
🇨🇦
Burlington, Ontario, Canada
The Center For Dermatology
🇨🇦
Richmond Hill, Ontario, Canada
Rosenpark Research
🇩🇪
Darmstadt, Germany
State Budget Institution of Higher Education North
🇷🇺
Saint-Petersburg, Russian Federation
NHS Lanarkshire
🇬🇧
Glasgow, United Kingdom
MediZen Premier Aesthetic Clinic
🇬🇧
Sutton Coldfield, United Kingdom
Etre Cosmetic Dermatology and Laser Center
🇺🇸
New Orleans, Louisiana, United States
Westlake Dermatology & Cosmetic Surgery - Westlake
🇺🇸
Austin, Texas, United States
DermResearch Inc.
🇺🇸
Austin, Texas, United States