A phase III, multicentre, double-blind, randomised, placebo-controlled and open-label study to evaluate the efficacy and safety of a single dose of IPN10200 in the improvement of moderate to severe glabellar lines in adult participants, and to evaluate the long-term efficacy and safety of repeat doses of IPN10200 in the same indication.
This study is looking at a new treatment called IPN10200 for people with moderate to severe frown lines (glabellar lines) between their eyebrows. It's designed to see if a single dose of IPN10200 can effectively smooth these lines and if it's safe to use. Researchers also want to find out how well the treatment works and stays safe when people receive repeat doses over a longer period. This is a crucial step to check if the treatment is really effective and safe before it can be more widely used, especially compared to a dummy treatment (placebo).
At a glance
What is this study about?
This study is looking into a new treatment called IPN10200, which is given as an injection, to help reduce the appearance of frown lines between the eyebrows. These lines are often called 'glabellar lines' and the study focuses on those that are moderate to severe.
The main aim is to find out if a single dose of IPN10200 can effectively improve these lines and if it's safe for people to use. The researchers will compare it to a 'placebo', which looks exactly like the treatment but doesn't contain any active medicine. This helps them understand if the improvements are really due to IPN10200 or something else. They also want to see if the treatment continues to work well and remain safe if people receive repeat doses over a longer time.
This is a 'Phase III' study, which means it's a very important stage. It's often the last step before a new treatment can be considered for wider use, looking closely at how effective and safe it is for a larger group of people. The results of studies like this help medical experts understand if a new treatment is a good option for people who want to manage their frown lines.
Key takeaways
- This study is testing a new injection for frown lines.
- It aims to see if the treatment is safe and effectively reduces moderate to severe frown lines.
- Some people will get the active treatment, others a dummy treatment (placebo).
- Repeat doses will also be studied for long-term effects.
- All participants must be at least 18 years old.
Who may be eligible?
To be part of this study, you need to be an adult, at least 18 years old. Both men and women can join.
The study is specifically for people who have moderate to severe frown lines between their eyebrows. These are the vertical lines that appear when you frown.
There will be other specific rules about who can and cannot join, which a study doctor will explain fully. For example, they might need to check your general health, any medications you take, or if you've had similar treatments before. This is to make sure the study is safe for you and that the results are clear.
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 18 years of age or older?
- Do you have moderate to severe frown lines between your eyebrows?
- Are you willing and able to attend regular clinic appointments?
- Are you generally in good health?
- Are you comfortable with receiving injections for treatment?
What does participation involve?
If you take part in this study, you will receive a single injection of either the study treatment (IPN10200) or a dummy treatment (placebo) in the muscles that cause frown lines. Some participants will then go on to receive repeat doses of IPN10200 over a longer period.
You will have several appointments at the study clinic. During these visits, the study team will carefully check your frown lines, assess how you feel about your appearance, and monitor your general health. This will include having an investigator (a trained professional) look at your lines both at rest and when you frown, and you will also be asked to rate your own lines and satisfaction. The exact number and timing of visits, as well as the total length of your participation, will be explained by the study team, but it will involve regular check-ups for a number of weeks or months.
Potential risks and benefits
Locations (2)
- —UnverifiedFrance
- —UnverifiedGermany
Common questions
What are glabellar lines?
Glabellar lines are the frown lines that appear between your eyebrows, often when you concentrate or show emotion.
What is a placebo?
A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain any active ingredients. It's used to see if the real treatment works better than no treatment at all.
What does 'single-blind' or 'double-blind' mean?
In a 'double-blind' study, neither you nor your study doctor knows if you're getting the active treatment or the placebo. This helps make the study results as fair as possible.
How is the treatment given?
The treatment, IPN10200, is given as an injection into the muscles around your frown lines.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, for any reason, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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