Glabellar LinesPhase 3NCT03795922
MT10109L in the Treatment of Glabellar Lines
A Phase 3 study testing MT10109L in people with Glabellar Lines, run by Medy-Tox at 15 sites in 3 countries.
Trial summary
To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- MT10109L
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 24 Dec 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
15 sites in 3 countries.
15 sites in 3 countries
United States9 sites
Westlake Dermatology & Cosmetic Surgery
Austin, Texas, 78746
Weinkle Dermatology
Bradenton, Florida, 34209
Aventiv Research, Inc.
Dublin, Ohio, 43016
Etre, Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, 70130
Dermatology and Laser Surgery Center of New York
New York, New York, 10028
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
SkinSearch of Rochester, Inc.
Rochester, New York, 14623
Investigate MD
Scottsdale, Arizona, 85255
Art of Skin MD
Solana Beach, California, 92075
Belgium4 sites
Universitair Ziekenhuis Brussel
Brussels, 1090
CHU Liege
Liège, 4000
Centre de la Fontaine
Loverval, Hainaut, 6280
Medical Skin Care
Sint-Truiden, Limburg, 3800
Russia2 sites
Kazan State Medical University
Kazan', Tatarstan Republic, 420105
Medical Centre Capital-Zdorovie
Moscow, 109369
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
To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.
- Conditions
- 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 the GL.
PlaceboDrug
Placebo will be injected into the GL.
| Study group | Role | What they receive |
|---|---|---|
| MT10109L | Experimental | MT10109L will be injected into the GL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. Receives: Drug: MT10109L |
| Placebo | Placebo comparator | Placebo will be injected into the GL: initial double-blind treatment on Day 1. 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 Glabellar Lines (GL) Severity at Maximum Frown at Day 30
The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 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 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 of double-blind period. 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 Duration of Glabellar Lines (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 (i.e., return to moderate or severe GL severity at maximum frown using the FWS).
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 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 of double-blind period. 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
Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration
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 from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)
Change from baseline at study exit.
Measured: Baseline to Study exit (Day 360 or early exit)
Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)
Change from baseline at study exit.
Measured: Baseline to Study exit (Day 360 or early exit)
Mean Change From Baseline in Vital Signs - Pulse Rate
Change from baseline at study exit.
Measured: Baseline to Study exit (Day 360 or early exit)
Mean Change From Baseline in Vital Signs - Respiratory Rate
Change from baseline at study exit.
Measured: Baseline to Study exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate
Change from baseline at study exit.
Measured: Baseline to Study Exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
Change from baseline at study exit.
Measured: Baseline to Study Exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
Change from baseline at study exit.
Measured: Baseline to Study Exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
Change from baseline at study exit.
Measured: Baseline to Study Exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
Change from baseline at study exit.
Measured: Baseline to Study Exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
Change from baseline at study exit.
Measured: Baseline to Study Exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
Change from baseline at study exit.
Measured: Baseline to Study Exit (Day 360 or early exit)
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: Up to Study Exit (Day 360 or early exit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start24 Dec 2018
- Primary completion13 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 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
- 234 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
- NCT03795922
- Sponsor's protocol ID
- MT10109L-001
- Other IDs
- 2018-004384-31, 2018
- Status last verified
- Jul 2023
- First submitted
- 20 Dec 2018
- Last updated
- 27 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 27 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 Glabellar Lines
- ClinicalTrials.gov ID
- NCT03795922
- Acronym / sponsor ID
- MT10109L-001
- Conditions
- Glabellar Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Posted 27 Jun 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 in the treatment of glabellar lines (GL) in participants with moderate to severe GL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT10109L | Experimental | Drug: MT10109LMT10109L will be injected into the GL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be injected into the GL: initial double-blind treatment on Day 1. |
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 the GL. | Drug | MT10109L |
| PlaceboPlacebo will be injected into the GL. | Drug | 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 Glabellar Lines (GL) Severity at Maximum Frown at Day 30
Time frame: Day 30
The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 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 Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)
Time frame: Day 30
The Duration of Glabellar Lines (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 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
Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration
Time frame: The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)
Time frame: Baseline to Study exit (Day 360 or early exit)
Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)
Time frame: Baseline to Study exit (Day 360 or early exit)
Mean Change From Baseline in Vital Signs - Pulse Rate
Time frame: Baseline to Study exit (Day 360 or early exit)
Mean Change From Baseline in Vital Signs - Respiratory Rate
Time frame: Baseline to Study exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate
Time frame: Baseline to Study Exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
Time frame: Baseline to Study Exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
Time frame: Baseline to Study Exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
Time frame: Baseline to Study Exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
Time frame: Baseline to Study Exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
Time frame: Baseline to Study Exit (Day 360 or early exit)
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
Time frame: Baseline to Study Exit (Day 360 or early exit)
Number of Participants With Binding and Neutralizing Antibodies
Time frame: Up to Study Exit (Day 360 or early exit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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.
15 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 Glabellar Lines, run by Medy-Tox at 15 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 27 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 15 sites in United States, Belgium, Russia. 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 27 Jun 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 Glabellar Lines (GL) Severity at Maximum Frown 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 27 Jul 2023.