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Study on the Safety of Tirbanibulin and Diclofenac Sodium for Adults with Actinic Keratosis on the Face or Scalp

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Actinic Keratosis, a skin condition that appears as rough, scaly patches on the skin, often due to sun exposure. The study will use two treatments: Tirbanibulin 10 mg/g ointment, also known by its code name KX-01, and Diclofenac Sodium 3% gel, marketed as Solaraze. These treatments are applied to the skin to help manage the condition.

The purpose of the study is to determine the occurrence of a type of skin cancer called Squamous Cell Carcinoma and to evaluate the long-term safety of these treatments in adults with actinic keratosis on the face or scalp. Participants will be randomly assigned to use either tirbanibulin ointment or diclofenac gel. The study will last for three years, during which the safety and effectiveness of the treatments will be monitored.

Throughout the study, participants will apply the treatment to the affected area on their face or scalp. The tirbanibulin ointment is used for a short period of five days, while the diclofenac gel is used for a longer period of up to 90 days. The study aims to provide valuable information on the safety of these treatments and their ability to prevent the development of squamous cell carcinoma in patients with actinic keratosis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age and the presence of actinic keratosis on the face or scalp.

    A test field (TF) is identified, which is a 25 cm² area containing 2 to 8 visible lesions.

  2. Step 2

    Treatment administration

    The treatment involves the application of either tirbanibulin 10 mg/g ointment or diclofenac sodium 3% gel.

    Both medications are applied to the skin (cutaneous use) on the affected area as per the study protocol.

  3. Step 3

    Treatment duration

    The treatment is administered over a period of 3 years, with regular monitoring and assessments.

  4. Step 4

    Monitoring and assessments

    Regular assessments are conducted to monitor the incidence of squamous cell carcinoma (SCC) and other skin conditions.

    Safety assessments, including vital signs and physical examinations, are performed throughout the study.

  5. Step 5

    End of study

    The study concludes with a final assessment to evaluate the long-term safety and effectiveness of the treatment.

    The estimated end date for the study is July 31, 2027.

Who can join the trial?

9 criteria

  • Must be a male or female who is **18 years old** or older.
  • Must have a **treatment field (TF)** on the face or scalp, but not on the lips, eyelids, ears, or inside the nostrils. This area should:
    • Be a connected area measuring **25 square centimeters**.
    • Contain **2 to 8 visible and separate actinic keratosis (AK) lesions**. AK lesions are rough, scaly patches on the skin caused by sun exposure.
    • Have a clinical appearance that matches **Olsen grade 1**, which is a way to describe the severity of the skin condition.
    • If a woman of childbearing potential, meaning she is fertile, she must:
      • Have a **negative pregnancy test** at the start and before treatment.
      • Use **effective birth control methods** during the study.
      • Agree to have pregnancy tests during and at the end of the study.
      • Must be willing to **avoid sunlight or UV light exposure** to the face or scalp during the study, including avoiding tanning beds.
      • Must be able to understand the purpose and risks of the study, be willing and able to follow the study rules, and provide **written informed consent**. This means agreeing to participate after being informed about the study details.

Who cannot join the trial?

6 criteria

  • Patients who have a history of skin cancer other than Actinic Keratosis cannot participate. Actinic Keratosis is a rough, scaly patch on the skin caused by sun exposure.
  • Patients who are currently using other treatments for Actinic Keratosis are not eligible.
  • Patients with a known allergy to the study medications, such as tirbanibulin or diclofenac, cannot join the study.
  • Patients who are pregnant or breastfeeding are excluded from participating.
  • Patients who have participated in another clinical trial within the last 30 days are not eligible.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate are excluded.
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Investigated drugs

  • Tirbanibulin

    is an ointment used in this study to treat actinic keratosis, a skin condition that can lead to squamous cell carcinoma. It is applied directly to the affected areas on the face or scalp. The study aims to assess the long-term safety of this medication and its effectiveness in preventing the development of skin cancer.

  • Diclofenac Sodium

    is a gel used in this study as an active treatment for actinic keratosis. It is applied to the skin to help reduce the risk of developing squamous cell carcinoma. The study compares the safety and effectiveness of this gel with the ointment to determine which is better at preventing skin cancer over a long period.

What is already known about the treatment

  • Tirbanibulin

    Tirbanibulin is applied as a topical ointment, specifically designed for use on the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating actinic keratosis, a skin condition that can lead to squamous cell carcinoma. The medication works by inhibiting specific proteins involved in cell growth, thereby preventing the proliferation of abnormal skin cells. Tirbanibulin is classified as a microtubule inhibitor, which interferes with the cellular structures necessary for cell division.

  • Diclofenac Sodium

    Diclofenac Sodium is administered as a topical gel, applied directly to the skin. It is being evaluated in clinical trials for its long-term safety and effectiveness in treating actinic keratosis, a condition that can progress to skin cancer. The gel works by reducing inflammation and inhibiting enzymes that contribute to abnormal cell growth. Diclofenac Sodium is classified as a non-steroidal anti-inflammatory drug (NSAID), which helps to alleviate inflammation and pain.

Investigated diseases

Actinic Keratosis – Actinic Keratosis is a skin condition characterized by rough, scaly patches on the skin, primarily caused by prolonged exposure to the sun. These patches are often found on areas such as the face, ears, lips, back of the hands, forearms, scalp, or neck. The condition progresses slowly and can sometimes develop into squamous cell carcinoma, a type of skin cancer, if left untreated. The patches may be red, pink, or brown and can feel dry or like sandpaper. Actinic Keratosis is more common in fair-skinned individuals and those who have spent a lot of time outdoors. Regular monitoring and protection from further sun exposure are important to manage the condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514394-22-00Protocol codeM-14789-41Estimated enrolment450 patientsSponsorAlmirall S.A.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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