A prospective, randomized, evaluator- and subject blinded, multi-center investigation to assess efficacy and safety of three different dosages of the same injection pattern of LetibotulinumtoxinA in the treatment of moderate and severe horizontal forehead lines
This clinical trial is investigating a new anti-wrinkle treatment called Letybo®. It focuses on people who have moderate to severe horizontal lines across their forehead. The main goal is to find out how effective and safe this injection is. Researchers are testing three different amounts (doses) of Letybo® to see which works best. Participants and the evaluators won't know who receives which dose, or if they receive the treatment at all, to keep the results fair. The study hopes to provide clear information for future use, helping us understand how well Letybo® can reduce the appearance of these forehead lines.
At a glance
What is this study about?
This research study is looking into a new treatment called Letybo®. It's an injection designed to help reduce the appearance of lines across the forehead, often called frown lines or worry lines. The study is specifically for people who have these lines moderately or severely.
Think of this study as a careful test to see how well Letybo® works and if it's safe and causes few side effects. Researchers are comparing three different amounts (doses) of the injection. This helps them understand whether more of the treatment leads to better results, or if a smaller amount is just as effective and potentially safer. Both the people receiving the injections and the doctors assessing the results won't know which dose was given. This 'blinded' approach ensures that everyone's expectations don't influence the study’s findings, making the results more reliable.
The main thing researchers want to find out is if Letybo® can visibly smooth out forehead lines after four weeks. They will also repeatedly check the forehead lines over several months to see how long any improvements last. Beyond just looking at the lines, they'll also measure how satisfied people are with their appearance after treatment, and if they can still move their eyebrows naturally. This thorough approach aims to gather a complete picture of Letybo®'s effects.
Key takeaways
- Tests a new anti-wrinkle injection called Letybo®.
- Aims to reduce moderate to severe forehead lines.
- Compares three different doses of the treatment.
- Involves regular check-ups over 6 months.
- Open to women aged 18 and above.
- Will assess both appearance and patient satisfaction.
Who may be eligible?
This study is looking for women who are at least 18 years old. There's no upper age limit, meaning older women can also take part.
To be included, you must have noticeable lines across your forehead, specifically those that are considered moderate to severe. These are the horizontal lines that appear when you raise your eyebrows.
Because this is a specific study, there might be other health conditions or medications that could prevent you from joining. The study team will review your full medical history to make sure taking part is safe for you.
- Am I a woman?
- Am I at least 18 years old?
- Do I have noticeable (moderate to severe) horizontal lines across my forehead?
- Am I willing to attend several follow-up appointments over about 6 months?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you'll receive an injection of Letybo® at one of the participating clinics. You won't know if you're receiving a low, medium, or high dose.
Over the next few months, you'll need to attend several follow-up appointments. These visits are important for the doctors to check how well the treatment is working and to make sure you're not experiencing any unexpected side effects. At these appointments, your forehead lines will be carefully assessed, sometimes using special equipment to measure changes, and you'll complete questionnaires about how you feel about your appearance. The study will last about 24 weeks in total.
Potential risks and benefits
Locations (2)
- —Germany
- —Austria
Common questions
What is Letybo®?
Letybo® is a new injection being tested to reduce the appearance of horizontal forehead lines.
Who can join this study?
Women aged 18 and over with moderate to severe horizontal forehead lines can join.
Will I know if I'm getting the treatment?
Yes, you will receive the Letybo® injection, but neither you nor the doctors will know which dose you're getting.
How long will I be in the study?
The study will involve several visits over approximately 24 weeks (about 6 months).
What if I experience side effects?
The study team will closely monitor you and provide care for any side effects you might experience.
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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