Glabellar LinesPhase 3NCT03721016
MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)
A Phase 3 study testing MT10109L in people with Glabellar Lines and Lateral Canthal Lines, run by Medy-Tox at 21 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glabellar Lines, Lateral Canthal Lines
- What is being tested?
- MT10109L
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- 21 sitesin 4 countries
- Study dates
- 26 Oct 2018to 22 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
21 sites in 4 countries.
21 sites in 4 countries
United States9 sites
SkinDC
Arlington, Virginia, 22209
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Skin Research Institute LLC
Coral Gables, Florida, 33146
Advanced Research Associates
Glendale, Arizona, 85308
MD Laser, Skin, & Vein Institute
Hunt Valley, Maryland, 21030
Coleman Center for Cosmetic Dermatologic Surgery
Metairie, Louisiana, 70006
Laser & Skin Surgery Center of New York
New York, New York, 10016
Eye Research Foundation
Newport Beach, California, 92663
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Canada4 sites
Sweat Clinics of Canada
Toronto, Ontario, M5R 3N8
Dr. Shannon Humphrey Inc.
Vancouver, British Columbia, V5Z 4E1
Project Skin MD
Vancouver, British Columbia, V6H 1K9
Bertucci MedSpa Inc.
Woodbridge, Ontario, L4L 8E2
Germany4 sites
RZANY & HUND - Privatpraxis fur Dermatologie und Asthetische Medizin
Berlin, 10707
Privatpraxis Dr. Hilton & Partner
Düsseldorf, North Rhine-Westphalia, 40212
DRK-Kliniken Nordhessen
Kassel, Hesse, 34121
Studienzentrum Theatiner46
Munich, Bavaria, 80333
United Kingdom4 sites
Bermuda Practice
Basingstoke, Hampshire, RG24 9DT
Saleh Aesthetic Clinic Ltd.
Cheadle, England, SK8 2BD
Meyer Clinic
Chichester, West Sussex, PO18 8AN
Cranley Clinic
London, England, W1G 7JE
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 Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines
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.
- Conditions
- Glabellar Lines, Lateral Canthal 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
MT10109Lwill be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.
PlaceboDrug
Placebo will be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.
| Study group | Role | What they receive |
|---|---|---|
| MT10109L Dose 1 + Placebo | Experimental | MT10109L Dose 1 will be injected into the Glabellar Lines (GL) and Placebo into the Lateral Canthal Lines (LCL): 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 Glabellar Lines (GL) and MT10109L Dose 2 into the Lateral Canthal Lines (LCL): 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 Glabellar Lines (GL) and into the Lateral Canthal Lines (LCL): 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)
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.
Measured: Day 30
Secondary outcomes (17)
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).
Measured: Day 1 (first treatment) to Day 180
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.
Measured: Day 30
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.
Measured: Day 60
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.
Measured: Day 30
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.
Measured: 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)
Mean Change From Baseline in Systolic Blood Pressure (BP)
Changes in vital signs: Systolic BP
Measured: Baseline to Day 360 (Study exit)
Mean Change From Baseline in Diastolic Blood Pressure (BP)
Changes in vital signs: Diastolic BP
Measured: Baseline to Day 360 (Study exit)
Mean Change From Baseline in Pulse Rate
Changes in vital signs: Pulse Rate
Measured: Baseline to Day 360 (Study exit)
Mean Change From Baseline in Respiratory Rate
Changes in vital signs: Respiratory Rate
Measured: Baseline to Day 360 (Study exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate
Change from baseline for ECG safety population - Heart Rate
Measured: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
Change from baseline for ECG safety population - PR Interval
Measured: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
Change from baseline for ECG safety population - QRS duration
Measured: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
Change from baseline for ECG safety population - QT interval
Measured: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
Change from baseline for ECG safety population - QTcB interval
Measured: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
Change from baseline for ECG safety population - QTcF interval
Measured: Baseline to Day 360
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
Change from baseline for ECG safety population - RR interval
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: Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start26 Oct 2018
- Primary completion5 Mar 2020
- Study completion22 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 Glabellar 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
- 415 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
- NCT03721016
- Sponsor's protocol ID
- MT10109L-005
- Other IDs
- 2014-005301-21, 2014
- Status last verified
- Apr 2023
- First submitted
- 24 Oct 2018
- Last updated
- 25 May 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 25 May 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 Glabellar Lines With or Without Concurrent Treatment of Lateral Canthal Lines
- ClinicalTrials.gov ID
- NCT03721016
- Acronym / sponsor ID
- MT10109L-005
- Conditions
- Glabellar Lines, Lateral Canthal Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Posted 21 Apr 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 glabellar lines (GL) with or without concurrent treatment of lateral canthal lines (LCL) in participants with moderate to severe GL and LCL.
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 Glabellar Lines (GL) and Placebo into the Lateral Canthal Lines (LCL): 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 Glabellar Lines (GL) and MT10109L Dose 2 into the Lateral Canthal Lines (LCL): 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 Glabellar Lines (GL) and into the Lateral Canthal Lines (LCL): 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: NivobotulinumtoxinAMT10109Lwill be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both. | Drug | MT10109L Dose 1 + MT10109L Dose 2, MT10109L Dose 1 + Placebo |
| PlaceboPlacebo will be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both. | 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)
Time frame: Day 30
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.
17 secondary outcomes
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)
Time frame: Day 1 (first treatment) to Day 180
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)
Time frame: Day 30
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)
Time frame: Day 60
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS)
Time frame: Day 30
Secondary Safety: Number of Patients Who Experienced an Adverse Event (AE)
Time frame: 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)
Mean Change From Baseline in Systolic Blood Pressure (BP)
Time frame: Baseline to Day 360 (Study exit)
Mean Change From Baseline in Diastolic Blood Pressure (BP)
Time frame: Baseline to Day 360 (Study exit)
Mean Change From Baseline in Pulse Rate
Time frame: Baseline to Day 360 (Study exit)
Mean Change From Baseline in Respiratory Rate
Time frame: Baseline to Day 360 (Study exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - 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: Day 360
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 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
21 sites in 4 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 Glabellar Lines and Lateral Canthal Lines, run by Medy-Tox at 21 sites in 4 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 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada, Germany, United Kingdom. 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 21 Apr 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) (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 25 May 2023.