Lateral Canthal LinesPhase 3NCT03732833
MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines
A Phase 3 study testing MT10109L in people with Lateral Canthal Lines and Glabellar Lines, run by Medy-Tox at 20 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Canthal Lines, Glabellar Lines
- What is being tested?
- MT10109L
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 425 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 5 Nov 2018to 25 Jan 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States11 sites
Westlake Dermatology & Cosmetic Surgery - Westlake
Austin, Texas, 78746-4720
DermResearch Inc.
Austin, Texas, 78759
Susan H. Weinkle, MD
Bradenton, Florida, 34209-5642
Aventiv Research Inc.
Dublin, Ohio, 43016
Etre Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, 70130-4353
Dermatology and Laser Surgery Center of New York
New York, New York, 10028
M3 Wake Research Inc.
Raleigh, North Carolina, 27612-8106
Skin Search of Rochester Inc.
Rochester, New York, 14623
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, 85255-4134
Art of Skin MD
Solana Beach, California, 92075-2228
Wilmington Dermatology Center
Wilmington, North Carolina, 28403
Germany5 sites
Hautzentrum Koln - Cologne Dermatology
Cologne, 50996
Rosenpark Research
Darmstadt, Hesse, 64283
Hautok and Hautok-cosmetics
München, 80333
MediCorium Zentrum fuer Dermatologie und Aesthetik
Oberursel, 61440
CentroDerm GmbH
Wuppertal, 42287
Canada4 sites
Dermetics Cosmetic Dermatology
Burlington, Ontario, L7N 3N2
Nectar Research Group Inc.
Richmond Hill, Ontario, L4B 1A5
Dr. Jean Carruthers Cosmetic Surgery Inc.
Vancouver, British Columbia, V5Z 4E1
Pacific Derm
Vancouver, British Columbia, V6H 4E1
About this study
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
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.
- Conditions
- Lateral Canthal Lines, Glabellar Lines
- Being tested
- MT10109L, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT10109LDrug
Also called NivobotulinumtoxinA
MT10109L will be injected into either the LCL, or both the LCL and GL.
PlaceboDrug
Placebo will be injected into either the GL, or both the LCL and GL.
| Study group | Role | What they receive |
|---|---|---|
| MT10109L Dose 1 + Placebo | Experimental | MT10109L Dose 1 will be injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. Receives: Drug: MT10109L; Drug: Placebo |
| MT10109L Dose 1 + MT10109L Dose 2 | Experimental | MT10109L Dose 1 will be injected into the LCL and MT10109L Dose 2 into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. Receives: Drug: MT10109L |
| Placebo | Placebo comparator | Placebo will be injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Secondary outcomes (17)
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.
Measured: Day 30
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.
Measured: Day 1 (first treatment) to Day 180
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.
Measured: Day 60
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.
Measured: Day 30
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.
Measured: AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose.
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.
Measured: Baseline to Day 360
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.
Measured: Baseline to Day 360
Mean Change From Baseline in Pulse Rate
The outcome reported here is the mean change in Pulse Rate from baseline to study exit.
Measured: Baseline to Day 360
Mean Change From Baseline in Respiratory Rate
The outcome reported here is the mean change in Respiratory Rate from baseline to study exit.
Measured: Baseline to Day 360
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.
Measured: Baseline to Day 360
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.
Measured: Baseline to Day 360
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.
Measured: Baseline to Day 360
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.
Measured: Baseline to Day 360
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.
Measured: Baseline to Day 360
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.
Measured: Baseline to Day 360
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.
Measured: Baseline to Day 360
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.
Measured: Baseline to Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start5 Nov 2018
- Primary completion5 Mar 2020
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lateral Canthal LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SangMi Park, Study director, Medytox Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732833
- Sponsor's protocol ID
- MT10109L-006
- Other IDs
- 2014-005302-38, 2014
- Status last verified
- Jul 2023
- First submitted
- 5 Nov 2018
- Last updated
- 17 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03732833
- Acronym / sponsor ID
- MT10109L-006
- Conditions
- Lateral Canthal Lines, Glabellar Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Posted 17 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MT10109L Dose 1 + Placebo | Experimental | Drug: MT10109L, Drug: PlaceboMT10109L Dose 1 will be injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. |
| MT10109L Dose 1 + MT10109L Dose 2 | Experimental | Drug: MT10109LMT10109L Dose 1 will be injected into the LCL and MT10109L Dose 2 into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT10109LAlso: NivobotulinumtoxinAMT10109L will be injected into either the LCL, or both the LCL and GL. | Drug | MT10109L Dose 1 + MT10109L Dose 2, MT10109L Dose 1 + Placebo |
| PlaceboPlacebo will be injected into either the GL, or both the LCL and GL. | Drug | MT10109L Dose 1 + Placebo, Placebo |
Primary outcome
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
Time frame: 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.
17 secondary outcomes
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)
Time frame: Day 30
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
Time frame: Day 1 (first treatment) to Day 180
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)
Time frame: Day 60
The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)
Time frame: Day 30
Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs)
Time frame: AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose.
Mean Change From Baseline in Systolic Blood Pressure (BP)
Time frame: Baseline to Day 360
Mean Change From Baseline in Diastolic Blood Pressure (BP)
Time frame: Baseline to Day 360
Mean Change From Baseline in Pulse Rate
Time frame: Baseline to Day 360
Mean Change From Baseline in Respiratory Rate
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Mean Heart Rate
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
Time frame: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
Time frame: Baseline to Day 360
Number of Participants With Binding and Neutralizing Antibodies
Time frame: Baseline to Day 360
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SangMi Park study director
Medytox Inc
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MT10109L in people with Lateral Canthal Lines and Glabellar Lines, run by Medy-Tox at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Germany, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.