Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines

Researchers are conducting a study to see how safe and effective a new medicine, IPN10200, is for reducing moderate to severe lines on the upper face, such as frown lines, forehead lines, and crow's feet. They are comparing different doses of IPN10200 against a dummy treatment (placebo) and an approved medicine called Dysport. The goal is to discover the best dose of IPN10200 that offers the most benefit with the fewest side effects. This study will involve up to 727 adults aged 18 to 65. It's happening in different stages, gradually testing IPN10200 to learn more about how it works on different areas of the face and over time. Participants will receive injections and have their lines assessed by experts.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Ipsen

Enrolment target

727

Start

06 Apr 2021

Estimated completion

19 Aug 2027

Moderate to Severe Upper Facial Lines

What is this study about?

This research study is looking at a new treatment called IPN10200, which aims to improve the look of moderate to severe lines on the upper part of your face. These lines can include frown lines (between your eyebrows), forehead lines, and lines around your eyes (often called crow's feet). The main goal is to find out if IPN10200 is safe and if it works well to reduce these lines. Researchers will be testing different amounts, or 'doses', of IPN10200. They want to discover the dose that provides the best results with the fewest side effects. They'll compare it to a dummy treatment (placebo, which has no active medicine) and also to a treatment that is already approved for similar uses called Dysport.

The study will involve up to 727 adults and is split into different stages. Initially, they will test IPN10200 on frown lines, carefully increasing the dose to see what is safe and effective. Later stages will explore its effects on forehead lines and crow's feet, sometimes in combination with frown lines. Some participants might have the chance to receive repeat treatments over time to see how long the effects last and to gather more information on longer-term safety. This step-by-step approach helps researchers learn a lot about the new medicine in a careful and controlled way.

By taking part, you would be helping medical science understand a potential new treatment for facial lines. This research is important because it could lead to another option for people who are bothered by these lines and are looking for ways to reduce their appearance. The safety and effectiveness of IPN10200 have not yet been fully established, which is why studies like this are so important.

Key takeaways

Tests a new medicine (IPN10200) for upper facial lines.
Compares IPN10200 to a dummy treatment and an existing medicine (Dysport).
Aims to find the safest and most effective dose of IPN10200.
Involves up to 727 adults, aged 18-65.
Study includes multiple stages, gradually testing different facial areas.
Participants will receive injections and have their lines regularly checked.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old. You must have moderate or severe lines on your upper face, which will be carefully checked by the study doctors. This specific study is for individuals who are genuinely bothered or very bothered by the appearance of these lines.

For the first part of the study, you would specifically need to have moderate to severe frown lines. Later stages will also include people with moderate to severe forehead lines and/or crow's feet. Both men and women can generally take part, though for the very first step of the study, only women will be included.

The study team will ask you to read and sign an informed consent form, making sure you understand what's involved. You'll also need to be able to follow all the study instructions, including any rules about contraception.

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 moderate to severe frown lines, forehead lines, and/or crow's feet that bother you?
Are you willing and able to attend multiple clinic visits?
Are you able to understand and sign an informed consent form?
Are you able to follow study instructions, including any about contraception?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive injections of either IPN10200 (at a specific dose), a placebo (a dummy treatment), or Dysport. The type and number of injections would depend on which stage of the study you are in. You'll have regular visits to the clinic where study doctors and nurses will assess your facial lines, usually through examinations and photographs. They will also monitor your health and any side effects you might experience.

In some parts of the study, especially the later stages, you might be able to receive up to three additional treatments of IPN10200, meaning you could have up to four treatments in total over the course of the study. This allows researchers to see how effective and safe the treatment is over a longer period. The total length of your participation would depend on which stage you join and if you receive repeat treatments, but it would involve multiple appointments over several months.

Potential risks and benefits

Taking part in a clinical study can have potential benefits, such as receiving a new treatment that might improve your facial lines, or having close medical monitoring. However, there are also potential risks, which will be fully explained before you join. These could include side effects from the injections themselves, like bruising, swelling, or pain at the injection site, or more specific reactions to the medicines being tested. The study is designed to carefully monitor your safety, and you would be able to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

MEDITI - Clinique Del Mar
Verified postcode
Antibes, France
Aimed S.A.S
Verified postcode
Lyon, France
Clinique de Chirurgie Esthétique Iéna
Verified postcode
Paris, France
Interdisciplinary Study Association
City only
Kassel, Germany
CRS Clinical Research Services Berlin GMBH
Verified postcode
Berlin, Germany
Interdisciplinary Study Association
Verified postcode
Berlin, Germany
ROSENPARK RESEARCH GmbH
Verified postcode
Darmstadt, Germany
Privatpraxis Dr. Hilton & Partner
Verified postcode
Düsseldorf, Germany
Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft
Verified postcode
Hamburg, Germany
Dermatologische Gemeinschaftspraxis Blankenfelde-Mahlow
Verified postcode
Mahlow, Germany

Common questions

What kind of lines on my face is this study looking at?

This study is focusing on moderate to severe lines on the upper part of the face, including frown lines (between your eyebrows), forehead lines, and lines around your eyes (crow's feet).

What is IPN10200?

IPN10200 is a new medicine being tested. It's not yet approved, and this study aims to find out if it's safe and effective for treating facial lines.

Will I definitely get the new medicine IPN10200?

Not necessarily. You could receive IPN10200, a placebo (a dummy treatment), or an existing treatment called Dysport. Which one you get is usually decided by chance.

How many times would I need to visit the clinic?

The study involves multiple visits for assessments and treatments. The exact number will depend on which part of the study you join and how long you participate, but it will be over several months.

Can I stop participating if I change my mind?

Yes, you have the right to leave the study at any time, for any reason, without it affecting your medical care.