AuthorisedPhase III and phase IV (Integrated)Interventional

Efficacy and Safety of Cryotherapy followed by Tirbanibulin ointment for actinic keratosis on the scalp and forehead

This research is investigating a new treatment approach for common skin conditions called actinic keratoses, which often appear as rough, scaly patches on sun-exposed areas like the scalp and forehead. These patches are a type of sun damage. The study is for adults aged 18 and over, both men and women, who have these patches. The treatment being tested involves two parts: first, freezing the patches (cryotherapy), and then applying an ointment called Tirbanibulin. Some participants will receive the active ointment, while others will get a 'dummy' ointment (placebo) that looks and feels the same but doesn't contain the active medicine. The main goal is to see how many people have their patches completely clear up after 8 months and to check for any side effects.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Centre Hospitalier Universitaire De Lille

Enrolment target

Start

28 Jun 2024

Patients (male or female) ≥18 years old with scalp and forehead actinic keratoses

What is this study about?

This study is looking into a new way to treat rough, scaly patches on the skin called actinic keratoses. These patches often form on areas of your body that get a lot of sun, like your scalp and forehead. They can sometimes turn into a more serious type of skin cancer if not treated, so finding effective treatments is important.

The researchers want to see how well a combination treatment works. This treatment involves first using a freezing technique (called cryotherapy) on the patches. After this, participants will use a special ointment called Tirbanibulin. Some people in the study will get the actual Tirbanibulin ointment, while others will get a placebo. A placebo is a cream that looks exactly like the real one but doesn't have any active medicine in it. This helps researchers compare the effects of the active treatment fairly.

The main aim is to find out if this combined approach can make the actinic keratosis patches completely disappear after 8 months. They will also be checking to see if the patches stay clear after a longer time, 12 months, and if the treatment causes any side effects or discomfort. This research is important because it could lead to better ways of treating these common skin conditions.

Key takeaways

The study tests freezing therapy plus an ointment for sun-damaged skin patches.
It's for adults with rough, scaly patches on their scalp or forehead.
The main goal is to see how well the patches clear up after 8 months.
Skin reactions and pain will be carefully monitored throughout the study.
Participation involves regular clinic visits for about 12 months.

Who may be eligible?

This study is looking for adults aged 18 years and older. Both men and women can take part. You must have actinic keratosis patches on your scalp or forehead to be considered for this study.

The researchers will need to check your skin to confirm you have these specific patches in the right areas. If you're unsure whether your skin condition fits, your doctor or the study team can help you understand the criteria.

There might be other reasons why you can or cannot join, so it's always best to discuss it with your doctor after reading the full study information.

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, scaly patches (actinic keratosis) on your scalp or forehead?
Are you willing to attend regular clinic appointments for up to 12 months?
Are you comfortable applying an ointment as instructed by the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first have an initial assessment to confirm you meet all the study requirements. Once enrolled, your actinic keratosis patches will be treated with freezing therapy (cryotherapy). After that, you will be asked to apply an ointment, either the active Tirbanibulin medicine or a placebo, to your treated areas. You won't know which one you are getting.

You'll have several follow-up visits over a period of 8 to 12 months. During these visits, the study team will carefully check your skin to see how the patches are responding. They'll assess if the patches have cleared up completely or partially, and keep track of any freezing sessions you receive. You'll also be asked about any skin reactions like redness, dryness, or crusting, and how much pain you might feel, using simple scales. To help track progress, photographs of your skin will be taken at your appointments. The total duration of your active participation, including follow-up, will be around 12 months.

Potential risks and benefits

Participating in this study might offer you access to a new treatment approach for your actinic keratosis, which could potentially clear your skin patches. However, there are potential risks, such as local skin reactions like redness, flaking, or discomfort from the freezing treatment or the ointment. Some people might experience pain during or after the treatment. As with any study, there's no guarantee that the treatment will work for you, or that you'll receive the active medication rather than the placebo. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

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

—
Unverified
France

Common questions

What is actinic keratosis?

Actinic keratosis is a common skin condition caused by too much sun exposure. It typically looks like rough, scaly, or crusty patches on the skin, often in areas like the scalp and forehead.

What is cryotherapy?

Cryotherapy is a medical treatment where patches of skin are frozen, usually with liquid nitrogen. This can help to destroy the abnormal skin cells of the actinic keratosis.

What is Tirbanibulin ointment?

Tirbanibulin ointment is a specific medicine designed to treat actinic keratosis. This study is looking at how it performs after cryotherapy.

What is a placebo?

A placebo is an inactive substance or treatment that looks identical to the real one. In this study, it's an ointment that looks like Tirbanibulin but doesn't have any medicine in it. It helps researchers compare results accurately.

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

No, during the study, neither you nor your doctor will know whether you are receiving the active Tirbanibulin ointment or the placebo. This helps prevent bias in the results.