MT10109L in the Treatment of 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 Lateral Canthal Lines
IRAS ID
260892
Contact name
David Eccleston
Contact email
Sponsor organisation
Allergan Ltd.
Eudract number
2014-005279-10
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 22 days
Research summary
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 lateral canthal lines (also called crow’s feet lines) at the outer corner of the eyes.
MT10109L is not yet approved for treatment of either frown lines or crow’s feet lines in North America, 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 MT10109L is better than a placebo. The placebo is a medically inactive substance that looks like the study medication, but does not contain any active ingredient.
The study is looking for approximately 225 participants globally with crow’s feet lines with 64 participants being recruited in the UK.
The study is split into 2 parts and if the participant qualifies to take part their participation will be for both parts. Both part 1 and part 2 will last approximately 6 months each.
Lay summary of study results: Summary of clinical study results Short study title: A clinical study to learn whether MT10109L (NivobotulinumtoxinA) worked and how safe it was in people with facial lines, known as 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 crow’s feet.
MT10109L will be called the “study medicine” in the rest of this summary.Who took part in the study?
In total, 235 adults with moderate to severe crow's feet took part.
Most participants were:
• Under 65 years of age (224 out of 235 people, 95.3%)
• Female (188 out of 235 people, 80%)
• White (219 out of 235 people, 93.2%)What study medicine did people receive?
People in the study received MT10109L (the study medicine) or a placebo. A placebo is often called a “sugar pill” or “dummy medicine”. It contains no active medicine. Placebo is used to help researchers understand and compare the effects of a study medicine on those receiving it to those not receiving it.What questions did researchers want to answer?
Researchers wanted to answer the following main questions:
• Did more people who received the study medicine have improvement in crow's feet after 30 days than people who received a placebo?
• How safe is the study medicine?What were the main results?
The study showed that in adults with moderate to severe crow's feet:
• receiving the study medicine resulted in more improvement of the appearance of crow's feet than in people who received placebo
• 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 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, this can cause 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 was split in 2 parts. Each part of the study lasted about 6 months.
In Part 1, participants were placed by chance in 1 of 2 groups:
• Group 1 received 24 units (U) of study medicine
• Group 2 received placebo
For every 3 participants, 2 participants were placed in Group 1, and 1 in Group 2. The study medicine and placebo were given in 6 injections (3 on each side) into the facial muscles in the outer corner of the eyes.
In Part 2, everyone received 24 U of study medicine up to 2 times.
Part 1 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.
Part 2 was “open label”. This means that the people taking part and the study doctors knew what people in the study were given.Who took part in the study?
People in the study lived in one of the following countries:
• Russian Federation
• United Kingdom
• United States
People could take part in this study if they:
• were at least 18 years of age
• had moderate or severe crow’s feet on both sides
• agreed to have digital photographs taken of their face.
People could not take part in this study if they had:
• certain muscle-weakening neurological disorders (e.g. amyotrophic
• lateral sclerosis – a nerve disease also known as ALS or Lou Gehrig’s disease, or myasthenia gravis, or Eaton-Lambert syndrome – autoimmune conditions which cause muscle weakness)
• prior exposure to or immunization for “botox” or any other botulinum toxin
• 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.
• After people joined the study, people in:
o Part 1 (double blind) received 6 injections in the crow’s feet area (3 on each side of the face) of the study medicine or placebo 1 time.
o Part 2 (open label) received up to 2 additional rounds of study medicine injections over a period of about 6 months. Each round was 6 injections in the crow’s feet (3 on each side of the face) of the study medicine.
When the study ended, Medytox Inc. reviewed and reported on the study data from this study. This document is a lay summary of that report.When did the research take place?
The study started in December 2018 and ended in January 2021.
Most people were in the study about 12 months.What were the main results?
Some results described here include fewer people than the total number of people who originally joined the study. Some people were not able to, or did not follow the study plan exactly, so their data were not included in the final results.
Researchers found that:
• More participants who received the study medicine reported a reduction of the crow’s feet compared to those who received placebo. The study doctors reported the same.
• 60 days after the first dose of study medicine, more participants who received the study medicine reported that they were mostly satisfied or very satisfied with the result compared to those who received placebo.
• Most unwanted effects were mild or moderate. The most common unwanted effects thought to be related to the study medicine or study procedure-related were bleeding at the injection site and headache.
• Receiving the study medicine a second or third time in Part 2 of the study caused fewer unwanted effects than occurred when people received the study medicine for the first time in Part 1.
Based on these results, researchers think that:
• The study medicine is more effective than placebo in the treatment of moderate to severe crow’s feet.
• The study medicine is generally safe and well-tolerated in people with moderate to severe crow’s feet.
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 medicine, placebo, or the study procedures.
This section is a summary of the unwanted effects people had during the study. All of these listed were thought to be related to the study 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?
• 78 out of 223 people (35%) who received the study medicine had at least 1 unwanted effect during the study. Out of these:
o 9 people (about 4%) had an unwanted effect thought to be related to the study medicine.
o 12 people (about 5.4%) had an unwanted effect thought to be related to the study procedure (injection).
• 12 out of 76 people (about 16%) who received placebo had at least 1 unwanted effect during the study. Out of these:
o No one had an unwanted effect thought to be related to the study medicine.
o 1 person (about 1.3%) had an unwanted effect thought to be related to the study procedure (injection).
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 procedures.What were the most common non-serious unwanted effects?
All unwanted effects thought to be related to the study medicine were non-serious (mild or moderate). The most common were:
• Injection site bleeding – 5 out of 223 people (about 2%)
• Headache – 2 out of 223 people (about 1%)
Other unwanted effects thought to be related to the study medicine occurred in only 1 person. 1 person had eyelid swelling and 1 person had sinus headache (pain and pressure in the face, forehead, and around the eyes).
During this study, the Sponsor had a special interest in specific unwanted effects, including unwanted effects that may have been due to the botulinum toxin spreading outside the injection area. These included eyelid and brow droop, facial pain, weakness in facial and other muscles, double vision, difficulties with speaking, breathing, and swallowing, and lung infection caused by inhaling food or liquids.
Out of 223 people who received the study medicine, 1 person had muscle weakness and 1 person had shortness of breath.
A total of 12 out of 223 people (about 5%) who received the study medicine had at least 1 unwanted effect thought to be related to the study procedure. These were bleeding, blood clot under the skin, bruising and pain at the injection site, headache, and sinus headache.
1 person out of 76 people (about 1%) who received the placebo had an unwanted effect thought to be related to the study procedure (bleeding).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 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:
• showed a greater reduction of crow’s feet in comparison to receiving placebo only
• was considered to be generally safe and well-tolerated in people with moderate or severe crow’s feet.
The findings from this study will be used to:
• seek approval from regulatory authorities for prescribing MT10109L to people who have moderate to severe crow's feet.Where can I find more information about this study?
You can find more detailed information on these websites:
• https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%2FNBTI%2F6ti_AQ%2FAQ%2Ffbab5f23-e8b6-4f19-b768-66b348d79b38%2F2%2FWfpKBcr6gc&data=05%7C02%7Ccoventryandwarwick.rec%40hra.nhs.uk%7Ce7afb7e6f6b14c8fc7c908ddc91aee29%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638887839681613218%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=0XwIhBKQx7Pfupj1gjPby1BU2BpLAN%2FD%2FMLmIOMRxL4%3D&reserved=0
• https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.clinicaltrialsregister.eu%252Fctr-search%252Fsearch%2FNBTI%2F6ti_AQ%2FAQ%2Ffbab5f23-e8b6-4f19-b768-66b348d79b38%2F3%2F3TOg2wnrZi&data=05%7C02%7Ccoventryandwarwick.rec%40hra.nhs.uk%7Ce7afb7e6f6b14c8fc7c908ddc91aee29%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638887839681647960%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=fxftHKfTlGkiEuTHVIsjPCxto8hEhGfZD69lb6q6jis%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 Lateral Canthal Lines National Clinical Trial (NCT) identification number: NCT03785145 EudraCT number: 2014-005279-10
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 Inc.
Email: aab501@medytox.comREC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
19/WM/0194
Date of REC Opinion
24 Sep 2019
REC opinion
Further Information Favourable Opinion