Glabellar LinesPhase 3NCT04157686
MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)
A Phase 3 study testing MT10109L Dose 1, MT10109L Dose 2 and MT10109L Dose 1 + Dose 2 in people with Glabellar Lines and Lateral Canthal Lines, run by Medy-Tox at 38 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glabellar Lines, Lateral Canthal Lines
- What is being tested?
- MT10109L Dose 1, MT10109L Dose 2 and MT10109L Dose 1 + Dose 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 957 participants
- Where
- 38 sitesin 6 countries
- Study dates
- 23 Oct 2019to 16 Feb 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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;
- 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.
Trial locations and contacts
38 sites in 6 countries.
38 sites in 6 countries
United States18 sites
SkinDC
Arlington, Virginia, 22209
Westlake Dermatology & Cosmetic Surgery - Westlake
Austin, Texas, 78746-4720
DermResearch Inc.
Austin, Texas, 78759
Bellaire Dermatology
Bellaire, Texas, 77401
Susan H. Weinkle
Bradenton, Florida, 34209-5642
Skin Research Institute
Coral Gables, Florida, 33146-1837
Aventiv Research Dublin
Dublin, Ohio, 43016
MD Laser Skin & Vein
Hunt Valley, Maryland, 21030
Coleman Center For Cosmetic Dermatologic Surgery
Metairie, Louisiana, 70006
Etre Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, 70130-4353
Laser & Skin Surgery Center of New York
New York, New York, 10016-4974
The Eye Research Foundation
Newport Beach, California, 92663-3637
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
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
Canada6 sites
Dermetics Cosmetic Dermatology
Burlington, Ontario, L7N 3N2
The Center For Dermatology
Richmond Hill, Ontario, L4B 1A5
Sweat Clinics of Canada
Toronto, Ontarion, M5R 3N8
Dr. Shannon Humphrey Inc.
Vancouver, British Columbia, V5Z 4E1
Project Skin MD LTD
Vancouver, British Columbia, V6H 1K9
Pacific Derm
Vancouver, British Columbia, V6H 4E1
Germany5 sites
Rosenpark Research
Darmstadt, 64283
Privatpraxis Dr. Hilton & Partner
Düsseldorf, 40212
Hautok and Hautok-cosmetics
München, 80333
Studienzentrum Theatiner46
München, 80333
MediCorium Zentrum fuer Dermatologie und Aesthetik
Oberursel, 61440
Russia4 sites
Kazan State Medical University
Kazan', 420012
Medical Center Capital - Zdorovie LLC
Moscow, 109369
Center dermatovenereology and cosmetology
Moscow, 119071
State Budget Institution of Higher Education North
Saint Petersburg, 194291
United Kingdom3 sites
Meyer Clinic
Chichester, PO18 8AN
NHS Lanarkshire
Glasgow, G71 8BB
MediZen Premier Aesthetic Clinic
Sutton Coldfield, B74 2UG
Belgium2 sites
UZ Brussel
Jette, Brussels Capital, 1090
Medical Skincare
Sint-Truiden, Limburg, 3800
About this study
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
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.
Read the 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.
- Conditions
- Glabellar Lines, Lateral Canthal Lines
- Being tested
- MT10109L Dose 1, MT10109L Dose 2, MT10109L Dose 1 + Dose 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT10109L Dose 1Drug
MT10109L Dose 1 will be injected into the GL area
MT10109L Dose 2Drug
MT10109L Dose 2 will be injected into the LCL area
MT10109L Dose 1 + Dose 2Drug
MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area
| Study group | Role | What they receive |
|---|---|---|
| Placebo/MT10109L Dose 1 | Experimental | 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 Receives: Drug: MT10109L Dose 1 |
| Placebo/MT10109L Dose 2 | Experimental | 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. Receives: Drug: MT10109L Dose 2 |
| Placebo/MT10109L Dose 1 + Dose 2 | Experimental | 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. Receives: Drug: MT10109L Dose 1 + Dose 2 |
| MT10109L Dose 1/Dose 1 | Experimental | 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. Receives: Drug: MT10109L Dose 1 |
| MT10109L Dose 2/Dose 2 | Experimental | 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. Receives: Drug: MT10109L Dose 2 |
| MT10109L Dose 1/Dose 1+2 | Experimental | 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. Receives: Drug: MT10109L Dose 1 + Dose 2 |
| MT10109L Dose 2/Dose 1+2 | Experimental | 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. Receives: Drug: MT10109L Dose 1 + Dose 2 |
| MT10109L Dose 1+2/Dose 1+2 | Experimental | 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. Receives: Drug: MT10109L Dose 1 + Dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced Any Adverse Event (AE)
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.
Measured: Baseline to Day 720 or Study Exit
Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs)
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.
Measured: Baseline to Day 720 or Study exit
Mean Change From Baseline in Pulse Rate (Beats Per Minute)
The outcome reported here is the mean change in pulse rate from baseline to study exit.
Measured: Baseline to Day 720 or Study Exit
Mean Change From Baseline in Systolic Blood Pressure (mm Hg)
The outcome reported here is the mean change in Systolic BP from baseline to study exit.
Measured: Baseline to Day 720 or Study Exit
Mean Change From Baseline in Diastolic Blood Pressure (mm Hg)
The outcome reported here is the mean change in Diastolic BP from baseline to study exit.
Measured: Baseline to Day 720 or Study Exit
Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)
The outcome reported here is the mean change in respiratory rate from baseline to study exit.
Measured: Baseline to Day 720 or Study 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: Baseline to Day 720 or Study Exit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start23 Oct 2019
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 957 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
- NCT04157686
- Sponsor's protocol ID
- MT10109L-004
- Other IDs
- 2014-005303-24, 2014
- Status last verified
- Aug 2024
- First submitted
- 23 Oct 2019
- Last updated
- 9 Aug 2024
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04157686
- Acronym / sponsor ID
- MT10109L-004
- Conditions
- Glabellar Lines, Lateral Canthal Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 957 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Posted 9 Aug 2024
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo/MT10109L Dose 1 | Experimental | Drug: MT10109L Dose 1The 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 | Experimental | Drug: MT10109L Dose 2The 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 | Experimental | Drug: MT10109L Dose 1 + Dose 2The 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 | Experimental | Drug: MT10109L Dose 1The 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 | Experimental | Drug: MT10109L Dose 2The 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 | Experimental | Drug: MT10109L Dose 1 + Dose 2The 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 | Experimental | Drug: MT10109L Dose 1 + Dose 2The 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 | Experimental | Drug: MT10109L Dose 1 + Dose 2The 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 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;
- 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.
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 |
|---|---|---|
| MT10109L Dose 1MT10109L Dose 1 will be injected into the GL area | Drug | MT10109L Dose 1/Dose 1, Placebo/MT10109L Dose 1 |
| MT10109L Dose 2MT10109L Dose 2 will be injected into the LCL area | Drug | MT10109L Dose 2/Dose 2, Placebo/MT10109L Dose 2 |
| MT10109L Dose 1 + Dose 2MT10109L Dose 1 will be injected into the GL area plus MT10109L Dose 2 will be injected into the LCL area | Drug | MT10109L Dose 1+2/Dose 1+2, MT10109L Dose 1/Dose 1+2, MT10109L Dose 2/Dose 1+2, Placebo/MT10109L Dose 1 + Dose 2 |
Primary outcome
Number of Participants Who Experienced Any Adverse Event (AE)
Time frame: 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)
Time frame: 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 Pulse Rate (Beats Per Minute)
Time frame: 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 Systolic Blood Pressure (mm Hg)
Time frame: 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 Diastolic Blood Pressure (mm Hg)
Time frame: Baseline to Day 720 or Study Exit
The outcome reported here is the mean change in Diastolic BP from baseline to study exit.
Mean Change From Baseline in Respiratory Rate (Breaths Per Minute)
Time frame: Baseline to Day 720 or Study Exit
The outcome reported here is the mean change in respiratory rate from baseline to study exit.
Number of Participants With Binding and Neutralizing Antibodies
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- 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.
38 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MT10109L Dose 1, MT10109L Dose 2 and MT10109L Dose 1 + Dose 2 in people with Glabellar Lines and Lateral Canthal Lines, run by Medy-Tox at 38 sites in 6 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 2 inclusion and 5 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Canada, Germany, Russia, United Kingdom and 1 more country. 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. 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 9 Aug 2024). 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?
Number of Participants Who Experienced Any Adverse Event (AE) (time frame: Baseline to Day 720 or Study Exit). The study lists 7 primary outcomes in all. 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 9 Aug 2024.