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Study on the Effectiveness and Safety of Tirbanibulin Ointment for Adults with Actinic Keratosis on the Face or Scalp

Fast replyRegistered drugNo placebo
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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 a skin condition called Actinic Keratosis, which often appears on the face or scalp. This condition is characterized by rough, scaly patches on the skin caused by long-term exposure to the sun. The study will evaluate the effectiveness and safety of a treatment called Tirbanibulin 10 mg/g ointment, also known by its code name KX2-391. This ointment is applied directly to the skin and is being tested to see how well it works in clearing the affected areas.

The purpose of the study is to assess how effective Tirbanibulin is in treating Actinic Keratosis compared to a placebo, which looks like the treatment but does not contain the active ingredient. Participants in the study will apply the ointment to a specific area of their skin that is larger than 25 cm² and up to 100 cm². The study will last for several weeks, with the main evaluation taking place at Day 57, which is about eight weeks after starting the treatment. Some participants may receive a second course of treatment, and their progress will be checked again by Day 113.

Throughout the study, the number of skin lesions will be counted and compared to the initial count to determine the treatment's effectiveness. The study aims to see if there is a significant reduction in the number of lesions and if the skin clears up completely in some cases. This research is important for finding better ways to manage and treat Actinic Keratosis, providing valuable information on the potential benefits of Tirbanibulin ointment for patients with this condition.

The research process

The trial runs in 6 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, such as age and the presence of actinic keratosis (AK) on the face or scalp.

    Participants must agree to avoid excessive sunlight or UV light exposure during the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to document the number and size of AK lesions.

    A treatment field (TF) is identified, which must measure more than 25 cm² and up to 100 cm².

  3. Step 3

    Treatment administration

    Participants are randomly assigned to receive either tirbanibulin 10 mg/g ointment or a placebo ointment, referred to as the vehicle.

    The ointment is applied cutaneously to the TF once daily for five consecutive days.

  4. Step 4

    Follow-up assessments

    Follow-up assessments occur at various intervals to evaluate the efficacy of the treatment.

    The primary assessment is conducted on Day 57 to measure the percent change in lesion count.

  5. Step 5

    Secondary assessments

    Secondary assessments include evaluating the proportion of patients with partial clearance (PC) and complete clearance (CC) of lesions by Day 57 and Day 113.

    PC is defined as 75% clearance, and CC is defined as 100% clearance of lesions.

  6. Step 6

    Completion of the study

    The study concludes with a final assessment to determine the overall effectiveness and safety of the treatment.

    Participants are monitored for any side effects or adverse reactions throughout the study duration.

Who can join the trial?

6 criteria

  • Patients must have Actinic Keratosis (AK), which are rough, scaly patches on the skin, and be 18 years or older.
  • Patients should have a treatment field (TF) on the face or balding scalp, excluding lips, eyelids, and inside nostrils and ears, that contains between 4 to 12 visible and separate AK lesions. The area should be more than 25 square centimeters (about the size of one cheek) and up to approximately 100 square centimeters (about the size of the mid-face).
  • Patients must be willing to avoid too much sunlight or UV light exposure, including tanning beds, on the face or scalp during the study.
  • Women who can have children must have a negative pregnancy test before starting the study and use highly effective birth control methods during the study and for a period after the study ends. They must also agree to have pregnancy tests during and at the end of the study and not donate eggs during the study and for a period after it ends.
  • Sexually active males with female partners who can have children must agree to use two forms of birth control, one being a barrier method like a condom, during the study and for 90 days after their last dose of study treatment. They must also agree not to donate sperm or try to conceive during this time.
  • Patients must be able to understand the purpose and risks of the trial, be willing and able to follow the study rules, and provide written consent to participate.

Who cannot join the trial?

8 criteria

  • Patients who do not have Actinic Keratosis on the face or scalp cannot participate. Actinic Keratosis is a rough, scaly patch on the skin caused by sun exposure.
  • Patients who are not adults are excluded. This means only individuals who are 18 years or older can participate.
  • Patients who are unable to follow the study procedures or attend all required visits are not eligible.
  • Patients who have used certain treatments for Actinic Keratosis recently may be excluded. This includes treatments like creams or procedures that could affect the study results.
  • Patients with other skin conditions that might interfere with the study results are not eligible.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may be excluded.
  • Patients with a known allergy to any ingredient in the study ointment cannot participate.
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Investigated drugs

Tirbanibulin is an ointment used in this clinical trial to treat actinic keratosis, which is a skin condition caused by sun damage. The ointment is applied to the affected area on the face or scalp to help clear the lesions. The study aims to evaluate how effective and safe this treatment is when used on a larger area of skin.

What is already known about the treatment

Tirbanibulin – Tirbanibulin is an ointment applied topically to the skin, specifically designed for use on areas affected by actinic keratosis, such as the face or scalp. It is currently being evaluated in clinical trials to determine its effectiveness and safety for treating this condition. The main therapeutic indication for tirbanibulin is the treatment of actinic keratosis, a skin condition caused by prolonged sun exposure. At the molecular level, tirbanibulin works by inhibiting tubulin polymerization, which disrupts cell division and leads to the death of abnormal skin cells. It is classified pharmacologically as a microtubule inhibitor.

Investigated diseases

Actinic Keratosis – Actinic Keratosis is a skin condition characterized by rough, scaly patches on areas of the skin that have been exposed to the sun, such as the face or scalp. It occurs when skin cells are damaged by ultraviolet (UV) light, leading to abnormal growth. These patches can vary in color, appearing as red, pink, or brown, and may feel itchy or tender. Over time, the lesions can become thicker and more pronounced. While they are not cancerous, they have the potential to develop into skin cancer if left untreated. Actinic Keratosis is more common in fair-skinned individuals and those with a history of extensive sun exposure.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505487-11-00Protocol codeM-14867-33Estimated enrolment292 patientsSponsorAlmirall S.A.

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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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