In short
There is currently 1 ongoing clinical trial investigating new treatment options for Actinic Cheilitis, a condition affecting the lips due to prolonged sun exposure. This trial is testing the effectiveness and tolerability of Tirbanibulin ointment, aiming to help patients achieve complete healing of the affected lip area.
Clinical trial locations
- Germany
Study on the Tolerability and Effectiveness of Tirbanibulin for Patients with Actinic Cheilitis
This clinical trial is investigating a treatment called Tirbanibulin, available as Klisyri 10 mg/g ointment, for patients with Actinic Cheilitis. The condition causes rough, scaly patches on the lips, primarily the lower lip, as a result of prolonged sun exposure. These patches can become dry, discolored, and sometimes tender or painful.
Main inclusion criteria:
- Participants must be at least 18 years old
- Must have a new or chronic diagnosis of the condition, confirmed by a special imaging scan called optical coherence tomography (OCT), showing signs such as white coloration, thickened skin, or sores on the lip
- Must have skin type I to III on the Fitzpatrick scale, which classifies skin based on how it reacts to sun exposure
- Must be able to provide written informed consent after understanding the study details
Main exclusion criteria:
- Pregnant or breastfeeding women cannot participate
- People with a history of allergic reactions to the study medication or similar drugs are excluded
- Patients currently using other treatments for the condition cannot join
- Individuals with a history of skin cancer on the lips are not eligible
- Those with other skin conditions that might interfere with results, serious medical conditions, or inability to follow study procedures are excluded
- People who participated in another clinical trial within the last 30 days cannot take part
Focus and goal: The main goal of the study is to determine whether the affected area on the lips is completely healed eight weeks after treatment. Participants will apply the Tirbanibulin ointment once daily for five consecutive days to the affected area. Researchers will monitor the healing process through several follow-up visits, measuring how much the affected area has reduced in size and gathering feedback from participants about their experience. The study will also evaluate any local skin reactions and overall oral health, using various diagnostic methods to track any side effects that may occur.
Investigational drug: Tirbanibulin is a topical medication that works by stopping the growth of abnormal cells that cause the rough patches on the lips. It is classified as a microtubule inhibitor, meaning it blocks certain proteins involved in cell growth. By reducing abnormal cell proliferation, it aims to improve the condition of the affected lip area and promote healing.
Summary
Currently, there is one active clinical trial for Actinic Cheilitis, taking place in Germany. This trial focuses on evaluating Tirbanibulin ointment as a potential treatment option. The study involves a short five-day treatment period followed by an eight-week monitoring phase to assess complete healing. This trial represents an important step in exploring new treatment approaches for this sun-damage-related lip condition, particularly for patients with fair skin who are most susceptible to developing it. The trial's design includes both objective measures of healing and patient feedback, providing a comprehensive assessment of the treatment's effectiveness and tolerability.
