A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU)
This research study, called PLATINUM EU, is investigating a new treatment named NT 201 for people who have noticeable bands in their neck, known as platysma prominence. These bands can become more visible with age or certain facial expressions. The study aims to find out if NT 201 is both safe and works better than a placebo (an inactive dummy treatment) to reduce the appearance of these bands. Participants will be involved for two periods: a main treatment period and an optional open-label extension period where everyone receives the active treatment. This is a Phase 3 study, meaning it's a later stage of research, usually involving a larger group of people to confirm earlier findings and gather more information on safety and effectiveness.
At a glance
What is this study about?
This study is looking into a new treatment called NT 201. The treatment is for people who have what are called 'platysma prominence'. These are the vertical bands or cords that can sometimes appear in the neck, especially when you make certain facial expressions or as you get older. They are caused by the platysma muscles in the neck becoming more obvious.
The main goal of this study is to see if NT 201 can safely and effectively reduce the appearance of these neck bands. To do this, researchers will compare NT 201 to a dummy treatment, called a placebo, which doesn't contain any active medicine. This helps them understand if any changes seen are truly due to the NT 201 or if they might happen anyway, or due to other factors. Participants won't know if they're receiving NT 201 or the placebo, and neither will their study doctor, until the study is over. This is called a 'blinded' study and helps make the results as fair and accurate as possible.
This study is an important step in determining if NT 201 could become a new option for people bothered by prominent neck bands. Researchers want to gather as much information as possible about how well it works and whether it has any side effects.
Key takeaways
- This study explores a new treatment (NT 201) for prominent neck bands.
- It aims to see if NT 201 is safe and works better than a dummy treatment.
- You would either receive NT 201 or a placebo during the main study.
- Adults aged 18-65 with moderate to severe neck bands are considered.
- Regular visits and assessments would be part of your participation.
Who may be eligible?
To join this study, you need to be an adult between 18 and 65 years old. A key requirement is that you must have noticeable bands in your neck (called platysmal bands) on both sides, identified by the study doctor. These bands must be considered at least 'moderate' or 'severe' when your neck muscles are tensed.
There are several reasons why you might not be able to join. For example, if you've ever had a bad reaction to similar treatments like botulinum toxin, or if you have any medical conditions that could make using this type of treatment risky. You also wouldn't be able to join if you've had certain cosmetic procedures on your face, jaw, or neck in the last year, or if you've had botulinum toxin injections in those areas in the past seven months. Planning to have similar treatments or surgeries during the study period would also prevent you from participating.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 65 years old?
- Do you have noticeable vertical bands in your neck (platysma bands) that a doctor might describe as 'moderate' or 'severe'?
- Have you avoided botulinum toxin treatments in your face, jaw, or neck in the last 7 months?
- Have you avoided lower face, neck, or chest cosmetic procedures or surgery in the last 12 months?
- Do you have any severe allergies to botulinum toxin or its ingredients?
- Do you have any medical conditions that might be risky with botulinum toxin treatment?
What does participation involve?
If you decide to take part in this study, you would first go through a screening process to check if you meet all the requirements. If you're eligible, you'd then be seen by the study team for various assessments and receive either NT 201 or the placebo. The exact number of visits and tests would be explained to you fully before you agree to join. You would have appointments regularly to monitor your progress and check for any side effects. After the main treatment period, there is an optional 'open-label' period where everyone receives the active NT 201 treatment.
Throughout the study, the research team will regularly assess the appearance of your neck bands and your general health. This could involve physical examinations, taking photographs, and asking you to complete questionnaires. The total time you would be involved in the study, including all follow-up appointments, would be clearly communicated to you.
Potential risks and benefits
Locations (26)
- Merz Investigative SiteVerified postcodeMunich, Germany· Recruiting
- Merz Investigative SiteVerified postcodeBlankenfelde-Mahlow, Germany· Recruiting
- Merz Investigative SiteVerified postcodePotsdam, Germany· Recruiting
- Merz Investigative SiteVerified postcodeFriedrichsdorf, Germany· Recruiting
- Merz Investigative SiteVerified postcodeKassel, Germany· Recruiting
- Merz Investigative SiteVerified postcodeBochum, Germany· Recruiting
- Merz Investigative SiteVerified postcodeDüsseldorf, Germany· Recruiting
- Merz Investigative SiteVerified postcodeDrensteinfurt, Germany· Recruiting
- Merz Investigative SiteVerified postcodeHamburg, Germany· Recruiting
- Merz Investigative SiteVerified postcodeHamburg, Germany· Recruiting
- Merz Investigative SiteVerified postcodeWuppertal, Germany· Recruiting
- Merz Investigative SiteVerified postcodeKrakow, Poland· Recruiting
Common questions
What are platysma bands?
Platysma bands are vertical lines or cords that can appear on the neck, often becoming more noticeable as we age or make certain expressions. They are formed by the muscles in the neck.
What is NT 201?
NT 201 is the name of the new treatment being tested in this study. It's a type of medicine called incobotulinumtoxinA, which is a form of botulinum toxin type A.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used in studies to compare against the active treatment and see if it truly makes a difference.
What does 'Phase 3' mean for a study?
Phase 3 is a later stage of clinical research. It means the treatment has already shown promise in earlier studies, and now it's being tested on a larger group of people to confirm its safety and effectiveness.
Will I get the actual treatment?
During the main part of the study, you have a chance of receiving either the active NT 201 treatment or a placebo. Neither you nor your study doctor will know which one you receive until the study is over. There is an optional follow-up period where everyone receives the active treatment.
How to find out more
Public Disclosure Manager Merz Aesthetics
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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