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Study on Tirbanibulin for Treating Superficial Basal Cell Carcinoma in Patients

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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 a skin condition known as superficial basal cell carcinoma, which is a common type of skin cancer that usually appears on the trunk or limbs. The treatment being tested in this study is an ointment called Tirbanibulin, also known by its brand name Klisyri. The purpose of the study is to evaluate how effective and safe this ointment is in treating superficial basal cell carcinoma.

Participants in the study will apply the Tirbanibulin ointment to the affected area of their skin. The study will monitor the treatment's effectiveness by checking for complete remission, which means there is no evidence of the cancer remaining. The study will also keep track of any side effects that may occur, noting their type, frequency, and severity. These side effects will be assessed using a standard scale to ensure they are properly understood and managed.

The study will take place over a period of time, with participants being observed for changes in their condition after one or more cycles of treatment. The thickness of the basal cell carcinoma will be measured using a special imaging technique to help determine the treatment's success. The overall goal is to see if Tirbanibulin can effectively treat this type of skin cancer while maintaining a good safety profile for patients.

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. This includes being over 18 years old, having a superficial basal cell carcinoma (BCC) on the trunk or limbs, and being able to understand the study instructions.

    Informed consent is required, which may be signed by a legal representative if necessary.

  2. Step 2

    Treatment initiation

    The treatment involves the application of Klisyri 10 mg/g ointment, which contains the active substance tirbanibulin.

    The ointment is applied directly to the skin (cutaneous use) where the BCC is located.

  3. Step 3

    Treatment cycles

    The treatment is administered in cycles. The number of cycles may vary, with assessments after each cycle to determine the need for further treatment.

    The goal is to achieve complete remission, which means no evidence of BCC is found clinically or through imaging techniques.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the type, frequency, and severity of any side effects are monitored. Side effects are classified using a standardized scale.

    The thickness of the BCC is measured using a specific imaging technique to assess treatment progress.

  5. Step 5

    Completion of treatment

    The primary goal is complete remission of the BCC by the end of the treatment period.

    Secondary assessments include evaluating the overall treatment experience and any side effects experienced during the study.

Who can join the trial?

6 criteria

  • Male and female patients over 18 years of age.
  • Patients with one or more primary, superficial Basal cell carcinomas (BCCs) on the trunk or limbs. This means a type of skin cancer that is on the surface of the skin.
  • The BCC must be primitive, meaning it is the first occurrence, and its longest side should be 15 mm or less.
  • Patient must be affiliated with a Social Security scheme, meaning they should be part of a health insurance program.
  • Patient should be likely to understand the study instructions.
  • Signed informed consent is required. If the patient cannot sign, a legal representative can do it for them.

Who cannot join the trial?

5 criteria

  • Patients with any other type of skin cancer besides Superficial Basal Cell Carcinoma cannot participate. This means if you have a different kind of skin cancer, you are not eligible.
  • Patients who have received treatment for their Superficial Basal Cell Carcinoma within the last 4 weeks are not eligible. This means if you have had any medical treatment for this condition recently, you cannot join the study.
  • Patients with a history of allergic reactions to the study medication, Tirbanibulin (Klisyri®), cannot participate. If you have had an allergic reaction to this medication before, you are not eligible.
  • Patients who are pregnant or breastfeeding are not eligible. This means if you are expecting a baby or nursing, you cannot join the study.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate. This means if you cannot commit to the study schedule, you are not eligible.
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Investigated drugs

Tirbanibulin (Klisyri®) is being studied for its effectiveness and safety in treating superficial basal cell carcinoma, a common type of skin cancer. This medication is applied directly to the skin and works by stopping the growth of cancer cells. The trial aims to determine how well this treatment can reduce or eliminate the cancerous lesions.

What is already known about the treatment

Tirbanibulin (Klisyri®) – This medication is applied topically, meaning it is used directly on the skin. It is currently being studied for its effectiveness in treating superficial basal cell carcinoma, a common type of skin cancer. Tirbanibulin works by inhibiting specific proteins involved in cell growth, which helps to stop the proliferation of cancer cells. It is classified as a microtubule inhibitor, targeting the cellular structures necessary for cancer cell division.

Investigated diseases

Superficial Basal Cell Carcinoma – This is a common form of skin cancer that arises from the basal cells, which are found in the outermost layer of the skin. It typically appears as a small, shiny bump or a red patch on areas of the skin that are frequently exposed to the sun, such as the face, ears, neck, and back. The progression of this cancer is usually slow, and it rarely spreads to other parts of the body. Over time, the affected area may become larger and develop a crust or bleed. Although it is generally not aggressive, it can cause significant local damage if left untreated.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-505971-66-00Protocol code23-PP-04Estimated enrolment55 patientsSponsorCentre Hospitalier Universitaire De Nice

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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).