#1 Clinical Trials Search in Europe

Tirbanibulin

Tirbanibulin is an emerging topical medication being studied in clinical trials for various skin conditions, primarily actinic keratosis (AK) and basal cell carcinoma (BCC). This article summarizes recent clinical trials investigating the safety, efficacy, and patient outcomes of tirbanibulin ointment for treating these common skin issues.

Table of Contents

What is Tirbanibulin?

Tirbanibulin is a new medication used to treat certain skin conditions. It’s also known by the brand name Klisyri[2] or Tirbaso[2]. Tirbanibulin belongs to a class of drugs called microtubule inhibitors, which means it works by interfering with cell division[5].

What Conditions Does Tirbanibulin Treat?

Tirbanibulin is primarily used to treat two skin conditions:

  • Actinic Keratosis (AK): This is a rough, scaly patch on the skin caused by years of sun exposure. It’s considered a precancerous lesion, meaning it can potentially develop into skin cancer if left untreated[2][3].
  • Basal Cell Carcinoma (BCC): This is a type of skin cancer that usually develops on areas exposed to the sun, like the face and neck. Specifically, Tirbanibulin is being studied for use in superficial basal cell carcinoma (sBCC), which affects the top layer of skin[1][5].

How Does Tirbanibulin Work?

Tirbanibulin works by stopping the growth and division of abnormal skin cells. As a microtubule inhibitor, it interferes with the structures inside cells that are necessary for cell division. This helps to eliminate the abnormal cells that make up actinic keratoses and basal cell carcinomas[5].

How is Tirbanibulin Used?

Tirbanibulin comes as an ointment that you apply directly to the affected area of skin. The typical treatment regimen is:

  • Apply once daily for 5 consecutive days[2][3].
  • The ointment is usually applied to an area of about 25 square centimeters (about the size of a credit card)[5].
  • Some studies are looking at using it on larger areas, up to 100 square centimeters[8].
  • The treatment area is typically on the face, scalp, or other sun-exposed areas like the neck, trunk, or extremities[5].

Your doctor will provide specific instructions on how to apply the ointment and how much to use.

How Effective is Tirbanibulin?

Clinical trials have shown promising results for Tirbanibulin in treating both actinic keratosis and basal cell carcinoma:

  • For actinic keratosis, studies measure “clearance” of lesions. Complete clearance means all lesions disappear, while partial clearance means at least 75% of lesions are gone[2].
  • For basal cell carcinoma, researchers look for both clinical clearance (visible disappearance of the lesion) and pathological clearance (no cancer cells found in a biopsy)[5].

The exact effectiveness rates are still being determined through ongoing studies.

What Are the Side Effects of Tirbanibulin?

Like all medications, Tirbanibulin can cause side effects. The most common side effects are local skin reactions in the treatment area, which may include:

  • Erythema (redness)
  • Flaking or scaling of the skin
  • Crusting
  • Swelling
  • Vesiculation (small blisters) or pustulation
  • Erosion or ulceration[7]

These reactions are usually mild to moderate and tend to resolve on their own after treatment. Serious side effects appear to be rare, but more long-term studies are ongoing to fully understand the safety profile of Tirbanibulin[9].

Ongoing Research on Tirbanibulin

Several clinical trials are currently underway to further study Tirbanibulin:

  • Testing its use on larger treatment areas[8].
  • Evaluating its effectiveness for basal cell carcinoma[1][5].
  • Comparing it to other treatments for actinic keratosis[9].
  • Assessing its impact on patients’ quality of life and satisfaction with treatment[6].
  • Studying its long-term safety and effectiveness[9].

These ongoing studies will help doctors and patients better understand the benefits and risks of Tirbanibulin treatment.

Aspect Details
Primary Conditions Studied Actinic Keratosis (AK), Superficial Basal Cell Carcinoma (sBCC)
Formulation Tirbanibulin 1% ointment
Typical Treatment Regimen Once daily application for 5 consecutive days
Treatment Areas Face, scalp, hands (varies by study)
Key Efficacy Measures Complete clearance, partial clearance, reduction in lesion count
Safety Assessments Local skin reactions, adverse events, laboratory tests, vital signs
Patient-Reported Outcomes Quality of life (Skindex-16), treatment satisfaction (TSQM)
Follow-up Duration Typically 8-12 weeks post-treatment
Emerging Applications Pediatric warts, larger treatment areas (up to 100 cm²)

FAQ

  • What is tirbanibulin used to treat? Tirbanibulin is primarily being studied for the treatment of actinic keratosis (AK) on the face and scalp. It's also being investigated for potential use in treating superficial basal cell carcinoma (sBCC) and warts.
  • How is tirbanibulin applied? Tirbanibulin is typically applied as a 1% ointment once daily for 5 consecutive days to the affected area. The treatment area can vary from 25 cm² up to 100 cm² depending on the study.
  • What are the common side effects of tirbanibulin? Common side effects include local skin reactions such as erythema (redness), flaking/scaling, crusting, swelling, and in some cases, vesiculation/pustulation or erosion/ulceration. These effects are usually mild to moderate and resolve over time.
  • How effective is tirbanibulin in treating actinic keratosis? Clinical trials have shown promising results for tirbanibulin in treating AK. Many studies measure complete or partial clearance of AK lesions, with some participants achieving 100% clearance and others showing significant reduction in lesion count.
  • Is tirbanibulin being studied for other skin conditions? Yes, in addition to AK, tirbanibulin is being investigated for treating superficial basal cell carcinoma (sBCC) and there's even a study looking at its potential use for warts on children's hands.

Ongoing Clinical Trials on Tirbanibulin

  • Study on Tirbanibulin for Treating Superficial Basal Cell Carcinoma in Patients

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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

    Not yet recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effectiveness and Safety of Cryotherapy and Tirbanibulin for Actinic Keratosis in Organ Transplant Patients

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

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

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

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

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy The Netherlands Poland Spain

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

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Actinic Keratosis (AK): A precancerous skin condition characterized by rough, scaly patches on areas frequently exposed to the sun, such as the face, scalp, and hands.
  • Basal Cell Carcinoma (BCC): The most common type of skin cancer, which usually develops on areas exposed to the sun and rarely spreads to other parts of the body.
  • Tirbanibulin: A topical medication being studied for skin conditions, typically formulated as a 1% ointment and applied once daily for 5 consecutive days.
  • Complete Clearance: The total disappearance of all treated lesions in a specific area after treatment.
  • Partial Clearance: A significant reduction (usually 75% or more) in the number of lesions after treatment, but not complete disappearance.
  • Local Skin Reaction (LSR): Skin changes at the site of treatment, which may include redness, flaking, crusting, swelling, or other visible effects.
  • Treatment Field (TF): The specific area of skin where the medication is applied during the study.
  • Health-Related Quality of Life (HRQoL): A measure of how a person's health affects their overall well-being and ability to function in daily life.
  • Skindex-16: A questionnaire used to assess the impact of skin conditions on a patient's quality of life, covering symptoms, emotions, and functioning.
  • Treatment-Emergent Adverse Event (TEAE): Any unfavorable medical occurrence that appears or worsens after starting a treatment in a clinical study.

References

  1. https://clinicaltrials.gov/study/NCT06112522
  2. https://clinicaltrials.gov/study/NCT05260073
  3. https://clinicaltrials.gov/study/NCT05900258
  4. https://clinicaltrials.gov/study/NCT06026358
  5. https://clinicaltrials.gov/study/NCT05713760
  6. https://clinicaltrials.gov/study/NCT05741294
  7. https://clinicaltrials.gov/study/NCT05279131
  8. https://clinicaltrials.gov/study/NCT06135415
  9. https://clinicaltrials.eu/trial/study-on-the-safety-of-tirbanibulin-and-diclofenac-sodium-for-adults-with-actinic-keratosis-on-the-face-or-scalp/