Outcomes Associated With Tirbanibulin for Large Field Application on the Face in the U.S (CLEAR) (CLEAR)
2026年6月16日 更新者：Avant Health LLC
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)
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.
研究概览
研究类型
观察性的
注册 (估计的)
30
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Siva Narayanan, PhD, MPhil, MHS, MSc
- 电话号码：301-799-AVANT
- 邮箱：info@avant-health.com
学习地点
-
-
California
-
Manhattan Beach、California、美国、90266
- 招聘中
- Ablon Skin Institute and Research Center
-
接触：
- Glynis Ablon, MD
- 电话号码：310-727-3376
- 邮箱：drablon@abloninstitute.com
-
首席研究员：
- Glynis Ablon, MD
-
-
South Carolina
-
Charleston、South Carolina、美国、29414
- 招聘中
- Dermatology & Laser Center of Charleston
-
首席研究员：
- Todd Schlesinger, MD
-
接触：
- Todd Schlesinger, MD
- 电话号码：843.377.2201
- 邮箱：skindoc@dermandlaser.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Study-eligible AK patients receiving usual care treatment in routine clinical practices in the U.S.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Tirbanibulin
Participants will receive tirbanibulin ointment 3.5 mg in 350 mg (as 1 single-dose packet per application, for 5 consecutive days).
The participants will be observed for 57 days to gather participant reported outcomes (PROs) and clinical profile.
|
Participants receiving tirbanibulin ointment 1% (3.5 mg tirbanibulin in 350 mg) as 1 single-dose packet per application, for 5 consecutive days
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Subject and clinician rating of current 'overall appearance of the skin' in the original AK treated area
大体时间：At end of study observation period, at day 57
|
The overall appearance of the skin in the original AK treated area (in comparison to baseline) is rated on a 5-point Likert scale of much worse, somewhat worse, no change, somewhat improved, much improved.
|
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
大体时间：At the end of study observation period, at day 57
|
Satisfaction is rated on a 7-point Likert scale of extremely satisfied, very satisfied, dissatisfied, somewhat satisfied, satisfied, very satisfied, extremely satisfied.
|
At the end of study observation period, at day 57
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
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
大体时间：At the end of study observation period, at day 57
|
At the end of study observation period, at day 57
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Siva Narayanan, PhD, MPhil, MHS, MSc、Avant Health LLC
- 首席研究员：Todd Schlesinger, MD、Avant Health LLC
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月2日
初级完成 (估计的)
2026年10月1日
研究完成 (估计的)
2026年10月1日
研究注册日期
首次提交
2026年6月9日
首先提交符合 QC 标准的
2026年6月16日
首次发布 (实际的)
2026年6月18日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月16日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.