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

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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 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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.09.2024

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 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.

Investigated diseases:

Actinic keratosis

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 ID:

2023-509931-15-00

Protocol code:

DRI_2023_0127

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?