Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Exploratory pilot study to determine the tolerability and effectiveness of Tirbanibulin in the treatment of Actinic Cheilitis

This study is an early investigation into a new cream called Klisyri (tirbanibulin 10 mg/g ointment) for treating a lip condition known as Actinic Cheilitis. Actinic Cheilitis causes rough, scaly patches on the lips due to sun damage. This particular study is in an early stage (Phase II) and aims to discover how well the cream helps lips heal completely and whether it causes any unwanted side effects. Participants will use the cream for a short period, and researchers will then check their lips after eight weeks to see if the affected area has fully recovered. The study also looks at how much the affected area shrinks and how participants feel about their lips and overall health during the trial.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Technische Universitat Dresden

Enrolment target

Start

17 Jul 2023

Actinic Cheilitis

What is this study about?

Imagine your lips have rough, scaly patches from too much sun exposure over the years. This condition is called Actinic Cheilitis. Doctors are testing a new cream, Klisyri (which contains a medicine called tirbanibulin), to see if it can help these patches heal. This is an early study, like a first step, to learn more about how well the cream works and if it's safe for people to use.

The main goal of this study is to see if the cream can help your lips fully recover from Actinic Cheilitis. Researchers will apply the cream for just 5 days, and then check 8 weeks later to see if the affected area on your lips has completely healed. This means they are looking for the rough patches to be completely gone.

Besides seeing if your lips heal, the researchers will also check other things. They'll measure how much the affected area shrinks, ask you how your lips feel, and see if it impacts your daily life. They will also keep a close eye on any reactions the cream might cause on your skin and record any other health changes you might experience during the study. They even use special cameras to take detailed pictures of your lips to help them understand the changes.

Key takeaways

Researchers are testing a new cream (Klisyri) for Actinic Cheilitis.
This is an early study to check if the cream helps lips heal and is safe.
The cream is used for 5 days, with follow-up over 8 weeks.
Participants must be 18 or older and have Actinic Cheilitis.
Taking part involves clinic visits and skin checks.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also take part. Both men and women are welcome to participate in this research.

The most important thing is that you have been diagnosed with Actinic Cheilitis, which is the condition this new cream is being tested for. If you don't have Actinic Cheilitis, this study wouldn't be right for you.

Beyond these general points, the study will have specific health checks to make sure it's safe for you to join. A doctor will discuss all the requirements with you to see if you are a good fit.

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?
Do you have Actinic Cheilitis?
Are you able to attend clinic visits for around 8 weeks?
Are you open to using a new cream on your lips for 5 days?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would use the study cream, Klisyri, on your lips for 5 days. After this, you would have several check-ups with the study team. The main check-up for how well the treatment worked would be 8 weeks after you started using the cream. During these visits, doctors will look at your lips very carefully, measure the affected area, and use special imaging tools to take detailed pictures. You will also be asked to complete questionnaires about how your lips feel and how your overall health is. The study team will keep track of any side effects you might experience. The total duration of your involvement in the study, from starting the cream to your final check-up, will be around 8 weeks.

Potential risks and benefits

Taking part in a study like this could potentially offer some benefits, such as receiving a new treatment that might improve your Actinic Cheilitis if other treatments haven't worked well. You would also receive careful monitoring from medical professionals throughout the study. However, there are also potential risks; the cream might cause side effects like skin irritation, redness, or other reactions. It's also possible the treatment might not work for you, or it could even make your condition worse. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is Actinic Cheilitis?

It's a skin condition on your lips, often caused by long-term sun exposure. It can make your lips feel rough or scaly.

What is Klisyri cream?

It's the name of the investigational cream containing a medicine called tirbanibulin that is being tested in this study.

How long do I use the cream for?

If you participate, you would apply the cream for 5 days.

Will my lips be completely cured by this treatment?

This study is trying to find out if the cream can lead to complete healing, but there's no guarantee the treatment will work for everyone.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point, and it won't affect your future medical care.