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Study on Cryotherapy and Tirbanibulin for Treating Actinic Keratosis on the Scalp and Forehead in Patients Aged 18 and Older

Verified siteRegistered 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 the treatment of actinic keratosis, a skin condition that often appears as rough, scaly patches on areas of the skin frequently exposed to the sun, such as the scalp and forehead. The treatment being tested involves a combination of cryotherapy, which is a method that uses extreme cold to destroy abnormal tissue, followed by the application of Klisyri 10 mg/g ointment, which contains the active substance tirbanibulin. This ointment is applied topically, meaning it is put directly on the skin.

The purpose of the study is to assess how effective and safe this combined treatment is for patients with actinic keratosis on the scalp and forehead. Participants in the study will first receive cryotherapy, and then apply the tirbanibulin ointment. If the actinic keratosis persists after four months, the treatment may be repeated. The study will monitor the response to the treatment over a period of eight months, with a follow-up assessment at twelve months to see if the actinic keratosis has completely disappeared or if there has been a significant reduction in the number of lesions.

Throughout the study, researchers will also observe any local skin reactions, such as redness, peeling, or swelling, and assess any pain experienced by participants. The study aims to provide valuable information on the effectiveness of this treatment approach for actinic keratosis, potentially offering a new option for managing this common skin 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the patient is 18 years or older and has at least 8 visible or palpable actinic keratosis lesions on the scalp and forehead.

    The lesions must be distributed in two non-overlapping zones of similar grade. The patient's general health condition is also evaluated.

  2. Step 2

    Cryotherapy session

    The first treatment involves a session of cryotherapy, a procedure that uses extreme cold to destroy abnormal tissue. This is applied to the affected areas on the scalp and forehead.

  3. Step 3

    Application of tirbanibulin ointment

    Following cryotherapy, Klisyri 10 mg/g ointment, containing the active substance tirbanibulin, is applied topically to the treated areas. The ointment is used as directed by the study protocol.

  4. Step 4

    Follow-up and assessment at 4 months

    At 4 months, a follow-up assessment is conducted to evaluate the response to the treatment. If persistent keratosis is observed, another session of cryotherapy may be administered.

  5. Step 5

    Evaluation at 8 months

    The primary endpoint is assessed at 8 months. This involves determining the complete response rate, which is defined as the absence of clinically detectable actinic keratosis in the treated area.

  6. Step 6

    Final assessment at 12 months

    A final assessment is conducted at 12 months to evaluate the complete and partial response rates. The partial response is defined as a 75% reduction in lesions.

    Local skin reactions such as redness, peeling, crusting, swelling, blisters, and ulcers are monitored and graded on a scale from 0 to 3. Pain is assessed using a visual analogue scale from 0 to 10.

Who can join the trial?

8 criteria

  • Patient must be at least 18 years old.
  • Patient must have at least 8 typical, visible, or touchable spots called **actinic keratosis** on the scalp, with at least 4 spots on each half of the scalp. **Actinic keratosis** are rough, scaly patches on the skin caused by sun exposure.
  • Patient must be in good general health, as judged by the study doctor, with a **WHO score of 2 or less**. This score is a way to measure how well a person can perform daily activities.
  • The **actinic keratosis** spots must be in two separate areas that do not overlap and are of similar severity.
  • Patient must be able to understand and agree to the schedule of study visits and other study requirements.
  • Patient must be able to understand and willingly sign a form that gives their consent to participate in the study.
  • Patient must have social insurance.
  • Patient must be willing to follow all the study procedures and stay in the study for its entire duration.

Who cannot join the trial?

2 criteria

  • Patients who are younger than 18 years old.
  • Patients who do not have actinic keratoses on the scalp and forehead. Actinic keratoses are rough, scaly patches on the skin caused by too much sun exposure.
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Investigated drugs

  • Cryotherapy

    is a treatment that uses extreme cold to freeze and destroy abnormal skin cells. In this trial, it is used to treat actinic keratosis, which are rough, scaly patches on the skin caused by sun damage. The goal is to remove these patches and prevent them from developing into skin cancer.

  • Tirbanibulin ointment

    is a topical medication applied to the skin. It is used in this trial to treat actinic keratosis on the scalp and forehead. The ointment works by stopping the growth of abnormal cells, helping to clear up the skin condition. It is applied after cryotherapy to enhance the treatment's effectiveness.

What is already known about the treatment

Tirbanibulin – Tirbanibulin is an ointment applied directly to the skin, specifically used for treating actinic keratosis on the scalp and forehead. It is currently being studied in clinical trials to evaluate its effectiveness and safety when used in combination with cryotherapy. The main therapeutic indication for tirbanibulin is actinic keratosis, a condition characterized by rough, scaly patches on the skin due to 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 as a microtubule inhibitor in pharmacology.

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 scalp and forehead. It is caused by long-term exposure to ultraviolet (UV) light, which leads to damage in the outer layer of the skin. The patches can vary in color, appearing pink, red, or brown, and may feel itchy or tender. Over time, these lesions can become more pronounced and may develop into a more serious skin condition if left untreated. Actinic keratosis is more common in older adults and those with fair skin. Regular monitoring and management are important to prevent progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509931-15-00Protocol codeDRI_2023_0127Estimated enrolment59 patientsSponsorCentre Hospitalier Universitaire De Lille

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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.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).