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Active not recruitingPHASE4INTERVENTIONAL

A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp

This research is looking at two different skin creams, Tirbanibulin ointment and Diclofenac gel. Both are used to treat a common skin condition called actinic keratosis, which usually appears on sun-exposed areas like the face or scalp. Actinic keratosis can sometimes turn into a type of skin cancer called squamous cell carcinoma (SCC). The main goal of this study is to see how good these two treatments are at preventing new SCCs from forming in the treated areas over a three-year period. By comparing them, we hope to find out which treatment is most effective at reducing this risk for people with actinic keratosis.

At a glance

Status
Active not recruiting
Phase
PHASE4
Sponsor
Almirall, S.A.
Enrolment target
447
Start
24 Oct 2022
Estimated completion
01 Jul 2027

What is this study about?

This study is designed to help us better understand how to manage a common skin condition called actinic keratosis. These are rough, scaly patches on your skin, often caused by years of sun exposure. While they are usually harmless, some actinic keratoses can, over time, develop into a type of skin cancer called squamous cell carcinoma. Finding effective ways to prevent this is really important.

In this study, we are comparing two treatments that are already available for actinic keratosis: Tirbanibulin ointment (sometimes known by its brand name, Klisyri®) and Diclofenac Sodium gel. We want to see which of these treatments is better at stopping new squamous cell carcinomas from developing on the face or scalp in people who have actinic keratosis. This is a long-term study, lasting for three years, to get a clear picture of their lasting effects.

By carefully observing participants over this period, we hope to gather valuable information. This will help doctors make better choices about which treatment might be most effective for preventing skin cancer in people with actinic keratosis. It's about ensuring patients receive the best possible care to protect their skin health in the long run.

Key takeaways

  • This study compares two creams for actinic keratosis: Tirbanibulin and Diclofenac.
  • The main goal is to see which cream is better at preventing a type of skin cancer.
  • The study focuses on actinic keratosis on the face or scalp.
  • It's a long-term study, lasting for three years.
  • Participation involves using a cream and regular check-ups with doctors.
  • Avoiding strong sun exposure on the treated area is important during the study.

Who may be eligible?

To join this study, your doctor will first check if you have actinic keratosis on your face or scalp in a specific area, about the size of a credit card. This area should have 2 to 8 clear actinic keratosis spots, and your skin should generally look healthy in that region.

There are also some important points about your general health. For women who could become pregnant, you'll need to have a negative pregnancy test and use reliable birth control throughout the study. Everyone taking part must be willing to avoid strong sunlight or sunbeds on their face or scalp during the study. You also need to understand what the study involves and be able to follow the study instructions.

You won't be able to join if your actinic keratosis is in certain areas, like your lips, eyelids, ears, or inside your nose. Also, if you have any unhealed wounds or suspicion of other types of skin cancer too close to the treatment area, you wouldn't be able to participate. If your actinic keratosis is very severe, unusual, or has been treated many times before without success, this study might not be 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.

  1. Do I have actinic keratosis on my face or scalp?
  2. Is my actinic keratosis in a specific area (not lips, eyelids, ears, or inside nose)?
  3. Am I willing to avoid direct sunlight or sunbeds on my face/scalp during the study?
  4. If I am a woman who could become pregnant, am I able to use effective birth control?
  5. Do I understand what the study involves and can I follow instructions?
  6. Do I have between 2 and 8 visible actinic keratosis spots in the area to be treated?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the Tirbanibulin ointment or Diclofenac Sodium gel to apply to the actinic keratosis on your face or scalp. Your doctor will explain exactly how and when to use it. You'll have regular check-ups over three years to see how your skin is responding and to monitor for any changes. This will include keeping an eye on the treated area for any signs of skin cancer. You'll also be asked to avoid strong sun or sunbeds on your face or scalp throughout the entire study. The exact number of visits and the duration of medication use will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit by closely monitoring your actinic keratosis and potentially reducing your risk of developing a serious skin cancer. However, there can be potential risks, such as local skin reactions to the medication like redness, dryness, or irritation. The study team will explain all known risks and closely monitor you for any side effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (49)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Almirall Investigation Site 102
    Verified postcode
    Lille, France
  • Almirall Investigation Site 103
    Verified postcode
    Marseille, France
  • Almirall Investigation Site 104
    Verified postcode
    Nice, France
  • Almirall Investigational Site 106
    Verified postcode
    Paris, France
  • Almirall Investigational Site 105
    Verified postcode
    Rouen, France
  • Almirall Investigational Site 101
    Verified postcode
    Saint-Priest-en-Jarez, France
  • Almirall Investigational Site 205
    Verified postcode
    Augsburg, Germany
  • Almirall Investigational Site 211
    Verified postcode
    Bad Bentheim, Germany
  • Almirall Investigation Site 201
    Verified postcode
    Bochum, Germany
  • Almirall Investigational Site 214
    Verified postcode
    Bochum, Germany
  • Almirall Investigational Site 212
    Verified postcode
    Bonn, Germany
  • Almirall Investigational Site 208
    Verified postcode
    Detmold, Germany

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 patches on the skin, often on the face, scalp, or hands.

Why is it important to treat actinic keratosis?

While most actinic keratosis spots are harmless, some can, over time, develop into a type of skin cancer called squamous cell carcinoma. Treating them can help reduce this risk.

What are Tirbanibulin ointment and Diclofenac gel?

These are both creams or gels used on the skin to treat actinic keratosis. They work in different ways to help clear up these skin patches.

Will I know which treatment I'm receiving?

This is a 'blinded' study, meaning you might not know if you're getting Tirbanibulin or Diclofenac, as this helps ensure we get fair results when comparing them.

How long will the study last?

This is a long-term study that will follow participants for three years to see the sustained effects of the treatments.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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