MT10109L treatment of frown lines with or without crow’s feet lines
Research type
Research Study
Full 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
IRAS ID
258382
Contact name
Jeffrey Stoker
Contact email
Sponsor organisation
Allergan Ltd.
Eudract number
2014-005301-21
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
121473, IND
Duration of Study in the UK
1 years, 8 months, 17 days
Research summary
Summary of Research
The purpose of this study is to look into the safety and efficacy of an investigational study medication called MT10109L, a botulinum toxin in liquid form, in the possible treatment of frown lines between the eyebrows when the frown lines are treated alone, or when the frown lines are treated at the same time when the crow’s feet lines on the outer corners of the eyes (lateral canthal lines) are treated.
MT10109L is not yet approved for treatment of frown lines or crow’s feet lines in Europe, or other regions, which is why it is being further researched in this study.
In addition, this study will compare MT10109L with a placebo to see if the MT10109L is better than a placebo. The placebo is a medically inactive substance that looks like MT10109L but does not contain any active ingredient.
This research study is looking for approximately 72 UK participants with frown lines and crow’s feet lines. The entire study will last about 1 year.Summary of Results
Summary of clinical study results Short study title: A clinical study to learn whether MT10109L (NivobotulinumtoxinA) worked and how safe it was in adults with facial lines, known as frown lines, when treated alone or together with crow’s feet.
Study sponsor: Medytox Inc.
Study medicine: MT10109L (NivobotulinumtoxinA) – a type of botulinum toxin. Botulinum toxin is a key ingredient in “botox”, one of the widely commercially available products.About this summary
The study medicine was also studied in 4 other previous studies to see how safe it was and how well it worked for the treatment of upper facial lines (frown lines and/or crow’s feet). In addition to those studies, the study medicine was assessed in this study. This summary only shows the results from this study.
Do not make any healthcare decisions based on a single study. These results are for information only.
This summary was completed in July 2025.Why was the research done?
No ready-to-use liquid type botulinum toxin product was available in the market at the time of the study. Other botulinum toxin products needed to be mixed with a saline solution. MT10109L is a ready-to-use liquid product and the researchers wanted to understand whether it works and how safe it is in the treatment of frown lines when treated alone or together with crow’s feet.
Researchers wanted to find a different way to treat moderate to severe facial lines in adults. They already answered questions about whether MT10109L (the potential new medicine) worked and how safe it was in previous studies. They then needed to further test MT10109L in order to seek approval in different countries. The approvals would allow the sponsor to market MT10109L. For this reason, MT10109L was compared with a placebo. A placebo, which is also sometimes called a dummy medicine, looks like MT10109L but does not have any real medicine in it.
MT10109L will be called the “study medicine” in the rest of this summary.Who took part in the study?
In total, 415 men and women aged 19 to 88 years with moderate to severe facial lines between their eyebrows and around their eyes, known as frown lines and crow’s feet, took part in this study.
Most participants were:
• Under 65 years of age (394 out of 415 people, 94.9%)
• Female (363 out of 415 people, 87.5%)
• White (394 out of 415 people, 94.9%).What study medicine did people receive?
People in the study received MT10109L (the study medicine), placebo, or both.
For every 5 participants:
• 2 participants received the study medicine in frown lines and placebo in crow’s feet
• 2 participants received the study medicine in frown lines and in crow’s feet, and
• 1 participant received placebo in frown lines and in crow’s feet.What questions did researchers want to answer?
Researchers wanted to answer the following main questions:
• How does the study medicine work in treating frown lines alone and in combination with treating crow’s feet?
• How does the study medicine work when compared to a placebo?
• How safe is the study medicine?What were the main results?
The study showed that in adults with moderate to severe frown lines and crow’s feet:
• receiving the study medicine resulted in more improvement of the appearance of frown lines (treated alone or together with crow’s feet line) than in people who received placebo only
• the study medicine was generally safe and well-tolerated.Did people experience any unwanted effects?
Unwanted effects are any kind of reaction to a medicine that is not the medicine’s intended effect. Unwanted effects can also be called “adverse reactions” or “adverse events”.
In this study, unwanted effects (either related or non-related to receiving the intervention) were reported by people receiving the study medicine and placebo.
The same unwanted effects were seen as those reported for other botulinum toxin products. These unwanted effects were generally mild or moderate.What was the purpose of the study?
Before a medicine can be used in people, researchers must find out whether it works and how safe it is.
Which condition did people in the study have?
Everyone in this study had moderate to severe facial lines between their eyebrows and around their eyes, known as frown lines and crow’s feet. These age-related facial lines are caused by repeated use of the face muscles to make facial expressions. As these lines become more defined and severe, they can cause a real emotional strain on the people it affects.
Many people can experience a wide number of feelings and emotions, including feeling less attractive, loss of self-esteem, and reduced well-being. This can have an impact on their mental health.Why was this study done?
At the time of this study, botulinum toxin products were used for reducing moderate to severe facial lines. By reducing these facial lines, some people feel better emotionally and see an improvement in their mental health and how they view themselves.
The study medicine is different to the other botulinum toxin products used at that time. Some other botulinum toxin products available then contained human or animal components, and were powders that had to be mixed with a saline solution before use. The study medicine came as a ready-to-use liquid and contained no human or animal components.
In previous studies, the study medicine was found to be generally safe, and reduced facial lines comparably to other botulinum toxin products.
In this study, the researchers hoped to find out how safe the study medicine was and how it worked compared to a placebo.Which medicine was studied?
The study medicine was MT10109L. The study medicine works by partially blocking the nerve signals to the muscles. This means the muscles work less often, allowing them to relax, which temporarily smooths facial lines.
The study medicine was compared with a placebo. Participants were placed, by chance, in 1 of 3 groups.
The 3 groups were:
• Group 1: people received 20 units (U) of study medicine for frown lines, and placebo for crow’s feet
• Group 2: people received 20 U of study medicine for frown lines, and 24 units of study medicine for crow’s feet, for a total of 44 U of study medicine
• Group 3: people received placebo for both facial line types.
The study medicine and/or placebo was injected into the facial muscles in the area(s) of the lines. This is on the outer corner of the eyes (crow’s feet) and between and above the eyebrows (frown lines).
This study was “double blind”. This means that neither the people taking part, nor the study doctors, knew who was given the study medicine or who was given the placebo. This was done to make sure that the study results were not influenced in any way.Who took part in the study?
People in the study lived in one of the following countries:
• Canada
• Germany
• United Kingdom
• United States
People could take part in this study if they were at least 18 years of age and had:
• moderate to severe frown lines when assessed by the study doctor and the participant
• moderate to severe crow’s feet on both sides when assessed by the study doctor
• sufficient sight without use of eyeglasses
• agreed to have digital photographs taken of their face.
People could not take part in this study if they had:
• received any botulinum toxin-type substance in the past
• immunization or oversensitivity to any botulinum toxin-type substance
• any nerve or muscle condition that the study medicine might affect
• drooping eyelid(s) or eyebrow(s)
• an infection or skin condition where the injections were to be given
• have an esthetic procedure (such as brow lift, eyebrow surgery, facelift, or thread lift), or permanent soft fillers and fat implantation
• plans to become pregnant or were pregnant or nursing.
People also needed to meet other criteria to take part.What happened during the study?
• Before each person received the study medicine or placebo, the study doctor and study staff checked to make sure the study was a good fit for them.
• The study had 2 parts, both were double blind and lasted around 6 months:
o Part 1: people received 1 round of injections with study medicine or placebo:
5 injections in the frown line area, and
6 injections (3 on each side of the face) in the crow’s feet area (11 injections on Day 1 of the study).
o Part 2: people who qualified received up to 2 additional rounds of study medicine or placebo injections between Month 6 and Month 11 of the study.
When the study ended, Medytox Inc. reviewed and reported on the study data from this study. This document is a lay summary of the parts of that report that relate to this study.When did the research take place?
The study started in October 2018 and ended in January 2021.
Most people were in the study about 12 months.What were the main results?
Researchers found that:
• Receiving study medicine to frown lines with or without crow’s feet lines showed reduction of facial lines.
o In comparison to receiving placebo only, receiving study medicine to frown lines with or without crow’s feet lines showed greater reduction of facial lines.
• More participants who received the study medicine to frown lines with or without crow’s feet lines reported they were mostly satisfied or very satisfied with the results compared with those who received placebo.
• Most unwanted effects were mild or moderate. The most common study medicine-related or study procedure-related unwanted effects were headache and pain where the injections were given (injection site pain).
Based on these results, researchers think that:
• receiving the study medicine was effective, safe, and well-tolerated in people with moderate to severe facial lines.
The study sponsor, Medytox Inc., plans to submit the data to the United States Food and Drug Administration (US FDA), Health Canada, European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, and other countries’ health authorities. The approvals would allow the sponsor to market the medicine.What were the unwanted effects?
An unwanted effect is a health problem that happens during a study that may or may not be related to the study medicine, placebo, or the study procedures.
This section is a summary of the unwanted effects people had during the study. Some of these listed were thought to be related to the medicine or study-related procedures. The website(s) listed at the end of this summary may have additional information about the unwanted effects.How many people had unwanted effects?
A total of 63 out of 415 people (about 15.2%) experienced an unwanted effect thought to be due to the study medicine or a study-related procedure.
An unwanted effect can be serious or non-serious. An unwanted effect is considered serious if it:
• leads to death or is life threatening,
• causes the person in the study to go to the hospital, or stay longer in the hospital,
• causes permanent disability or incapacity,
• causes a baby to be born with health problems, or
• could have developed into a serious or dangerous health problem for the person in the study, even if this was prevented from happening.What serious unwanted effects happened?
• No one in the study experienced a serious unwanted effect thought to be related to the study medicine or study-related procedures.What were the most common non-serious unwanted effects?
All unwanted effects thought to be related to the study medicine, placebo, or study-related procedures were non-serious (mild or moderate). The most common were:
• Injection site pain – 20 out of 415 people (about 4.8%)
• Headache – 15 out of 415 people (about 3.6%)
• Injection site bruising – 11 out of 415 people (about 2.7%).
During this study, the Sponsor had a special interest in some specific unwanted effects – eyelid droop, and blurred vision. These were reported by 3 people and 1 person, respectively, out of 415 people (about 1%).
The researchers also looked at unwanted effects that may have been due to the toxin spreading outside the injection area. These were reported by 5 out of 415 people (1.2%).Did anyone stop taking the study medicine because of an unwanted effect?
No one in the study stopped taking the study medicine because of an unwanted effect due to the study medicine.What do these safety results tell us?
These safety results tell us that the study medicine was considered to be generally safe and well-tolerated in adults with frown lines and crow’s feet.Thank you to everyone who took part
We would like to thank everyone who took part in this study for being part of the research. It takes a lot of people, in many studies all around the world, to advance medical research.How has this study helped people?
This study helped researchers to determine that treatment with the study medicine in the doses of 20 U for frown lines alone, or in combination with 24 U for crow’s feet:
• showed a greater reduction of facial lines in comparison to receiving placebo only
• was considered to be generally safe and well-tolerated in people with moderate to severe facial lines.
The findings from this study will be used to:
• seek approval from regulatory authorities for prescribing MT10109L to people who have moderate to severe frown lines and crow’s feet.Where can I find more information about this study?
You can find more detailed information on these websites:
• https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%2FNBTI%2F99i_AQ%2FAQ%2F7c22a4c5-15d7-400f-8286-6ba68340d335%2F2%2FGojX0MXJlt&data=05%7C02%7Capprovals%40hra.nhs.uk%7Cde71e0b0a9164bdf2dd308ddc91ca96e%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638887847152186606%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=hfk5%2Fa7naA6L%2B8QeKoU4BHDc5zdnxccxeOQlWW3dS%2Fw%3D&reserved=0
• https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.clinicaltrialsregister.eu%252Fctr-search%252Fsearch%253Fquery%253DMT10109L-005%2FNBTI%2F99i_AQ%2FAQ%2F7c22a4c5-15d7-400f-8286-6ba68340d335%2F3%2FYJWNfxrket&data=05%7C02%7Capprovals%40hra.nhs.uk%7Cde71e0b0a9164bdf2dd308ddc91ca96e%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638887847152207542%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=pt5P0vH%2BU2BK71yqkFUbsamnun99YdwWoV%2BqHE4VWt0%3D&reserved=0Full study 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 National Clinical Trial (NCT) identification number: NCT03721016 EudraCT number: 2014-005301-21
If there are more clinical studies with MT10109L, you can find them on the websites listed above. You can find them by searching for the words MT10109L or NivobotulinumtoxinA.
If you have any questions, please use the following contact details:
Company: Medytox
Email: aab501@medytox.comREC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0050
Date of REC Opinion
21 Jun 2019
REC opinion
Further Information Favourable Opinion