Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR)

Официальное название

Patient and Clinician Reported Outcomes Among Patients With Actinic Keratosis Receiving Tirbanibulin for Large fiEld Application on the Face, in U.S Clinical pRactice Settings: A Pilot Initiative (CLEAR)

Обзор

The goal of this observational study is to learn about the effectiveness of tirbanibulin among adult subjects with actinic keratosis (AK) lesions in the face. The main question it aim to answer is: How does tirbanibulin improve subject's overall appearance of the skin, improve how patient's skin looks, and improve patient's skin texture, in a 57-day observation period. Participants already taking tirbanibulin as part of their regular medical care for AK will answer online survey questions at the beginning of the study and at Day 57.

Вмешательства

• Препарат Tirbanibulin
  Participants receiving tirbanibulin ointment 1% (3.5 mg tirbanibulin in 350 mg) as 1 single-dose packet per application, for 5 consecutive days

Первичные конечные точки

• Subject and clinician rating of current 'overall appearance of the skin' in the original AK treated area [Срок оценки: At end of study observation period, at day 57]
• Subject and clinician rating of their satisfaction with the ability of tirbanibulin treatment to 'improve how skin looks' and 'improve skin texture' respectively, in the original AK treated area [Срок оценки: At the end of study observation period, at day 57]

Вторичные конечные точки (1)

• Proportion of Subjects with IGA success, defined as an IGA score of completely cleared (0) or partially cleared (1) in AK status in the treated area [Срок оценки: At the end of study observation period, at day 57]

Критерии участия

Критерии включения

• Diagnosed with AK on the face.
• Has clinically typical, visible, and discrete 4-12 AK lesions on the face.
• Considered as a potential candidate for tirbanibulin (Klisyri®) treatment to manage their AK lesions on the face.
• Male or female, aged 18 years and above at the time of initiation of treatment with tirbanibulin.
• Willing to avoid excessive sun or UV exposure, and/or use relevant sunscreen protection and protective clothing during the study duration.
• Able to read and write in English.
• Provide consent to participate in the study.
• Willing to comply with all study procedures (including photography tasks) and be available for the duration of the study.

Критерии исключения

• Patients with any dermatological condition of the face that could interfere with clinical evaluations.
• Hypertrophic AK lesions, open wounds, or suspected skin cancers within proximity of the treatment area.
• Anticipated need for in-patient hospitalization or in-patient surgery within the next 2 months.
• Patients unable to comply with the requirements of the study or patients who, in the opinion of the study physician should not participate in the study.
• Patients for whom medical chart is inaccessible to physicians to complete baseline data collection.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• Ablon Skin Institute and Research Center — Manhattan Beach
• Dermatology & Laser Center of Charleston — Charleston

Идентификаторы

NCT: NCT07657988 · 2051-AH-AK-TN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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