AuthorisedTherapeutic use (Phase IV)Interventional

Head-to-Head Comparison of the Efficacy and Safety of All Commercially Available Botulinum Neurotoxin Type A Products for the Treatment of Glabellar Rhytides: A Multicenter, Triple-Blind, Randomized Controlled Trial

This study is a comparison of several common anti-wrinkle injections used to treat frown lines between the eyebrows. Researchers want to understand how effective and safe these treatments are in real-world use. They'll be looking closely at how long the effects of each treatment last before the frown lines start to reappear. The study will also check for any side effects and how the treatments affect a person's quality of life and satisfaction. This is a "Phase 4" study, meaning the treatments are already approved and available, but researchers want to gather more information on their long-term performance.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Stichting Amsterdam UMC

Enrolment target

390

Start

18 Mar 2025

Glabellar frown rhytides (wrinkles).

What is this study about?

Imagine you're thinking about treatment for those frown lines between your eyebrows. This study is like a detailed look under the hood of several common anti-wrinkle injections that are already available. The main goal is to compare how well these different treatments work and how safe they are for reducing frown lines. Think of it as researchers wanting to understand the 'real-world' experience of people getting these injections.

Specifically, the study will be watching how long the smoothing effect of each injection lasts. They want to know when those frown lines start to show up again. This helps doctors and patients understand what to expect from each product. Beyond just the wrinkles, the study also focuses on people's overall experience – how happy they are with the results, how it affects their daily life and mood, and whether they have any side effects.

This type of study is called a 'Phase 4' clinical trial. This means the treatments being tested are already approved and regularly used by doctors. Phase 4 studies are important because they help us learn even more about how a treatment performs over time and in a broader group of people than during initial testing. It's all about making sure we have the clearest picture of what these treatments can do.

Key takeaways

Compares different approved anti-wrinkle injections for frown lines.
Main goal is to see how long the effects of each treatment last.
Also checks for safety, side effects, and how people feel about results.
Only for adult women (18+ years old) with frown lines.
You won't know which specific injection you receive in the study.
Participation helps us learn more about these common treatments.

Who may be eligible?

This study is looking for women who are 18 years old or older. You don't have an upper age limit, so if you're an adult woman with frown lines, you might be able to take part.

However, the study is specifically for women and does not include men. There might be other reasons why someone wouldn't be able to join, such as certain medical conditions or if they've recently had other treatments for their frown lines. These details would be discussed with you by the study team.

The main thing is that you need to be an adult woman interested in treatment for the frown lines between your eyebrows.

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 old or older?
Are you female?
Do you have frown lines between your eyebrows?
Are you generally in good health?
Have you discussed this with your doctor?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive one of the anti-wrinkle injection treatments. The specific treatment you get will be chosen randomly, like flipping a coin. You won't know which one you're getting, and neither will the doctors giving it or the people looking at the results – this helps keep the study fair.

Over several weeks, you'll have appointments to check on your frown lines and how you're feeling. They will measure if the lines have improved and for how long the effects last. You'll also be asked to fill out questionnaires about how happy you are with the treatment, how it affects your mood (like anxiety or depression), and any side effects you might experience. The total duration of your participation will involve regular check-ups and assessments, likely over a period of 16 weeks or possibly longer, with careful monitoring of any changes.

Potential risks and benefits

Participating in this study could offer you the benefit of receiving an anti-wrinkle treatment for your frown lines and contributing to valuable medical research. As with any injection, there's always a small risk of side effects, such as temporary bruising, swelling, or redness at the injection site. More rarely, specific side effects like a droopy eyelid have been reported with these types of treatments. You will be closely monitored for any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Netherlands

Common questions

What kind of wrinkles is this study about?

This study is looking at the frown lines that appear between your eyebrows.

Are the treatments safe?

Yes, all treatments in this study are already approved and widely used. The study is gathering more information on their long-term safety and effectiveness.

Will I know which treatment I'm getting?

No, you won't know which specific anti-wrinkle injection you receive. This helps ensure the study results are unbiased.

How long will I be in the study?

The study will follow you closely for at least 16 weeks, and potentially longer, to see how long the treatment effects last.

Who can join this study?

The study is open to adult women aged 18 and over who have frown lines between their eyebrows.