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

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What is this study about?

This clinical trial is focused on studying the treatment of actinic keratosis, a skin condition that often appears as rough, scaly patches on the skin due to long-term sun exposure. The study involves patients who have received a solid organ transplant. The treatment being tested is a combination of cryotherapy, which is a method that uses extreme cold to destroy abnormal tissue, and a topical ointment called tirbanibulin (known by the brand name Klisyri 10 mg/g ointment). The purpose of the study is to evaluate how effective this combination treatment is for reducing the number of actinic keratosis lesions in these patients.

Participants in the study will receive treatment on two symmetrical areas of their skin. One area will be treated with both cryotherapy and tirbanibulin, while the other area will receive only cryotherapy. This will help researchers compare the effectiveness of the combination treatment against cryotherapy alone. The study will monitor changes in the number of actinic keratosis lesions over a period of three months. Researchers will also observe any skin reactions and assess the patients’ quality of life and satisfaction with the treatment.

The study aims to provide valuable information on whether the addition of tirbanibulin to cryotherapy offers better results for patients with actinic keratosis who have undergone organ transplants. By understanding the potential benefits and any side effects, this research could lead to improved treatment options for managing this skin condition in transplant recipients.

1 joining the study

Upon joining the study, the patient must meet specific criteria, including being a solid organ transplant recipient with actinic keratosis (AK), having stable immunosuppressive treatment for at least six months, and having 4 to 8 AKs in two symmetrical areas of 25 cm².

The patient must be at least 18 years old and have given consent to participate. Women of childbearing potential must use a safe means of contraception during the treatment period and for at least one month afterward.

2 initial treatment phase

The treatment involves two phases. Initially, cryotherapy is applied to the affected areas. Cryotherapy is a procedure that uses extreme cold to destroy abnormal tissue.

3 application of tirbanibulin ointment

Following cryotherapy, the patient applies Klisyri 10 mg/g ointment, which contains the active substance tirbanibulin, to the treated areas. This ointment is used for cutaneous application, meaning it is applied directly to the skin.

The ointment is applied once daily for five consecutive days.

4 follow-up and assessment

The primary goal is to evaluate the percentage change in the number of AKs on the side treated with both cryotherapy and tirbanibulin after three months, compared to the side treated with cryotherapy alone.

Secondary assessments include the percentage of patients with a complete or partial response in lesion reduction, the number of new and persistent AKs, local skin reactions, treatment tolerance, and differences in quality of life scales.

5 completion of the trial

The trial is expected to conclude by December 16, 2024. The patient’s progress and response to treatment will be monitored throughout the study period.

Who Can Join the Study?

Must be a patient who has had a solid organ transplant. This means you have received an organ like a kidney, liver, or heart from a donor.
Must have actinic keratosis (AK), which are rough, scaly patches on the skin caused by sun exposure.
At least one year must have passed since your organ transplant.
Your immunosuppressive treatment should be stable for at least 6 months. This is the medication you take to prevent your body from rejecting the transplanted organ.
You should have between 4 to 8 actinic keratoses in two symmetrical areas of 25 square centimeters, either on the face or scalp, that can be treated.
You must be 18 years old or older.
You, or your representative, must agree to participate in the study by giving consent.
The study investigator must believe you can follow all the study requirements.
If you are a woman who can have children, you must agree to use a reliable form of contraception during the study and for at least one month after. Abstinence is considered an acceptable method. A negative pregnancy test is required at the start of the study.

Who Cannot Join the Study?

Patients who do not have actinic keratosis, which are rough, scaly patches on the skin caused by sun damage, cannot participate.
Patients who are not solid organ transplant recipients cannot participate. Solid organ transplant refers to receiving an organ like a kidney, liver, or heart from a donor.
Patients who are under the age of 18 or over the age of 65 cannot participate.
Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	15.02.2024

Trial locations

Investigated drugs:

Tirbanibulin

Cryotherapy is a treatment that uses extreme cold to freeze and destroy abnormal skin cells. In this trial, it is used as the first step in a sequential therapy to treat actinic keratosis, which are rough, scaly patches on the skin caused by sun damage. Cryotherapy helps to remove these damaged cells, making it an effective initial treatment for this condition.

Tirbanibulin is a topical medication applied directly to the skin. It is used in this trial as the second step in the sequential therapy following cryotherapy. Tirbanibulin works by stopping the growth of abnormal cells, helping to clear actinic keratosis lesions. This medication is particularly useful for patients who have undergone organ transplants, as it helps manage skin conditions that can arise due to their immunosuppressed state.

Investigated diseases:

Actinic keratosis

Actinic keratosis – Actinic keratosis is a skin condition characterized by rough, scaly patches on the skin, primarily caused by prolonged exposure to the sun. These patches are often found on areas such as the face, ears, neck, scalp, chest, backs of the hands, forearms, or lips. The condition progresses slowly and can vary in appearance, sometimes being red, pink, or brown. Over time, the patches may become thicker and more pronounced. Actinic keratosis is considered a precancerous condition, as it can potentially develop into skin cancer if left untreated. It is more common in fair-skinned individuals and those with a history of sunburns or extensive sun exposure.

Trial ID:

2023-508091-11-00

Protocol code:

TIRTRASP

Trial Phase:

Human Pharmacology (Phase I) – Other

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

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