Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Multicentre, Randomised, Double-blind, Vehicle-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tirbanibulin 10 mg/g Ointment Applied to a Treatment Field Larger Than 25 cm2 and up to 100 cm2 in Adult Patients With Actinic Keratosis

This research study is for adults who have a skin condition called actinic keratosis on their face or scalp. This condition often results from sun exposure and can sometimes turn into skin cancer. The study is testing a new ointment, Tirbanibulin, to see how well it clears these skin patches and if it's safe to use. Half the participants will get the real ointment, and the other half will get a dummy ointment (placebo) that looks and feels the same but has no medicine. Researchers will compare the results to understand if Tirbanibulin is an effective treatment. It's a key step in approving new medicines for general use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Almirall S.A.

Enrolment target

269

Start

17 Nov 2023

Actinic Keratosis on the Face or Scalp

What is this study about?

This study is a detailed investigation into a new ointment called Tirbanibulin. It's designed for people who have a common skin condition called actinic keratosis, which usually appears as rough, scaly patches on skin that has been exposed to the sun a lot, like the face or scalp. While these patches aren't usually harmful themselves, they can sometimes turn into a type of skin cancer, so it's important to treat them.

The main goal of this study is to see how effective Tirbanibulin ointment is at clearing up these patches. Researchers will be looking at how many patches disappear or get much better after treatment. They also want to make sure the ointment is safe to use and doesn't cause too many side effects.

To make sure the results are fair, some participants will receive the actual Tirbanibulin ointment, while others will receive a 'dummy' ointment, called a placebo. This placebo looks exactly like the real ointment but doesn't contain any medicine. Neither the participants nor the doctors will know who is getting which ointment until the end of the study. This helps to remove any bias and ensures the results accurately show the ointment's effects.

Key takeaways

This study is for adults with actinic keratosis on their face or scalp.
It tests a new ointment called Tirbanibulin against a dummy ointment.
The main aim is to see how well it clears skin patches and if it's safe.
You won't know if you're getting the active treatment or dummy treatment at first.
Regular visits to the clinic will be needed to check your skin.
You can leave the study at any time if you change your mind.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. Both men and women can take part. The main requirement is that you have actinic keratosis on your face or scalp.

The areas of your skin with actinic keratosis that the study will focus on need to be a certain size – larger than 25 square centimetres (about the size of a credit card) but not bigger than 100 square centimetres (roughly the size of an average smartphone screen).

There might be other health conditions or medicines you are taking that would mean you couldn't join the study, but these details would be discussed with you by the study doctor to make sure it's safe and suitable for you.

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 rough or scaly patches on your face or scalp?
Have you been diagnosed with actinic keratosis?
Is the total area of your patches larger than a credit card but smaller than a smartphone screen?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be given either the Tirbanibulin ointment or a dummy ointment to apply to your affected skin. The ointment comes in a small, single-use packet.

You will have several appointments at the study clinic. These visits will involve doctors checking your skin to see how the actinic keratosis is responding to the treatment. They will count the patches and assess how much they have cleared up. These check-ups will happen at specific times, for example, on day 57 and day 113 after you start treatment. The total duration of your participation in the study, including follow-up visits, will be explained in full by the study team.

Potential risks and benefits

Taking part in this study could potentially offer you a new treatment for your actinic keratosis before it's widely available. However, there's also a chance you might receive the dummy ointment, meaning your condition might not improve. As with any medication, there's always a risk of side effects from the Tirbanibulin ointment, such as skin irritation, although these will be carefully monitored. You are absolutely free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (5)

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

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Unverified
Spain
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Unverified
Netherlands
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Unverified
Poland
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Unverified
Italy
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Unverified
Germany

Common questions

What is actinic keratosis?

It's a common skin condition caused by too much sun exposure, appearing as rough, scaly patches, often on the face or scalp. It can sometimes, but not always, turn into skin cancer.

What is a 'dummy' ointment?

A dummy ointment, also called a placebo, looks and feels exactly like the active medicine but doesn't contain any drug. It helps researchers compare the real treatment's effects fairly.

Will I know if I'm getting the real medicine?

No, initially neither you nor your study doctor will know whether you are receiving the real Tirbanibulin ointment or the dummy ointment. This is to ensure unbiased study results.

How long will the study last for me?

The study involves regular check-ups over several weeks or months. The full timeline for your participation will be explained in detail by the study team.

Can I stop participating if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, without any impact on your standard medical care.