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Study on the Tolerability and Effectiveness of Tirbanibulin for Patients with Actinic Cheilitis

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 Actinic Cheilitis, a condition that affects the lips, often due to prolonged sun exposure. The trial will explore the use of a treatment called Tirbanibulin, which is available as an ointment under the name Klisyri 10 mg/g ointment. The purpose of the study is to determine how well this ointment works and how well it is tolerated by patients with Actinic Cheilitis.

Participants in the study will apply the Tirbanibulin ointment to the affected area on their lips for a period of five days. The study will then monitor the participants over several weeks to assess the healing process. The main goal is to see if the affected area on the lips is completely healed eight weeks after the treatment. The study will also look at how much the affected area has reduced in size and gather feedback from participants about their experience with the treatment.

Throughout the study, researchers will also evaluate any local skin reactions and overall oral health. They will use various methods to ensure accurate diagnosis and track any side effects that may occur. The study aims to provide valuable insights into the effectiveness of Tirbanibulin for treating Actinic Cheilitis and improve understanding of 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, you will be informed about the purpose and procedures involved. You will be required to provide written consent, confirming your understanding and agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes a clinical examination of your lips and possibly using imaging techniques to assess the condition of your skin.

  3. Step 3

    Treatment phase

    You will begin the treatment phase by applying Klisyri 10 mg/g ointment containing tirbanibulin to the affected area on your lips. This is a topical treatment, meaning it is applied directly to the skin.

    The ointment should be applied once daily for a duration of five days. Follow the instructions provided by the study team for correct application.

  4. Step 4

    Follow-up visits

    After completing the treatment, you will have scheduled follow-up visits. These visits are important to monitor your progress and any changes in the condition of your lips.

    The primary follow-up visit will occur eight weeks after the treatment, where the complete recovery rate will be assessed. This involves checking if the affected area has healed completely.

  5. Step 5

    Self-assessment and feedback

    You will be asked to provide self-assessment feedback regarding your experience and any changes you notice. This helps in understanding the effectiveness of the treatment from your perspective.

  6. Step 6

    Final evaluation

    A final evaluation will be conducted to compare the condition of your lips before and after the treatment. This includes measuring the size of the affected area and assessing any improvements.

    The study team will also evaluate any local skin reactions and overall oral health during this final visit.

Who can join the trial?

4 criteria

  • Must be 18 years or older.
  • Must have been newly diagnosed with Actinic Cheilitis or have chronic Actinic Cheilitis at the time of registration. This means having certain changes in the lip, like white coloration, thickened skin, or sores, confirmed by a special scan called optical coherence tomography (OCT).
  • Must have a skin type I to III on the Fitzpatrick scale, which is a way to classify skin types based on their reaction to sun exposure.
  • Must provide written informed consent after being fully informed about the study.

Who cannot join the trial?

8 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with a history of allergic reactions to the study medication or similar medications are excluded.
  • Patients currently using other treatments for Actinic Cheilitis cannot join the study. Actinic Cheilitis is a condition that affects the lips, often due to sun exposure.
  • People with a history of skin cancer on the lips are not eligible.
  • Participants who have had any other skin conditions that might interfere with the study results are excluded.
  • Individuals who have participated in another clinical trial within the last 30 days cannot take part.
  • Patients with any serious medical conditions that might affect their ability to complete the study are not eligible.
  • Individuals who are unable to follow the study procedures or attend all required visits are excluded.
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Investigated drugs

Tirbanibulin is a medication used in this clinical trial to treat a condition called Actinic Cheilitis, which affects the lips. This condition is caused by too much sun exposure and can lead to rough, scaly patches on the lips. Tirbanibulin works by stopping the growth of abnormal cells that cause these patches. In this trial, patients apply the medication to the affected area for five days to see if it helps reduce the size of the patches and improve the condition of their lips.

What is already known about the treatment

Tirbanibulin (Klisyri) – Tirbanibulin is a topical medication applied directly to the skin, specifically designed to treat Actinic Cheilitis, a condition that affects the lips. It is currently being studied in clinical trials to assess its effectiveness and tolerability for this condition. The main therapeutic indication for Tirbanibulin is the reduction of the affected area in patients with Actinic Cheilitis. At the molecular level, Tirbanibulin works by inhibiting certain proteins that are involved in cell growth, which helps to reduce abnormal cell proliferation. It is classified pharmacologically as a microtubule inhibitor.

Investigated diseases

Actinic Cheilitis – Actinic Cheilitis is a condition characterized by the inflammation and damage of the lips due to prolonged exposure to sunlight. It primarily affects the lower lip, causing it to become dry, scaly, and discolored. Over time, the affected area may develop rough patches or lesions that can feel tender or painful. The progression of the disease can lead to the thickening of the lip tissue and the formation of persistent ulcers. If left unchecked, these changes can become more pronounced, potentially leading to further complications. The condition is more common in individuals with fair skin and those who spend significant time outdoors without adequate lip protection.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502807-31-00Protocol codeTUD-AKTCHE-082Estimated enrolment20 patientsSponsorTechnische Universitaet Dresden

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