A Prospective Cohort Study of Patients With Actinic Keratosis (AK) in the Face or Scalp Treated With Tirbanibulin and Followed for 24 Weeks Post Treatment-initiation. Patient Reported Outcomes (PROs) and Clinical Profile of Patients Will be Gathered for Descriptive Analyses of Patient Outcomes Over the 24-week Study Observation Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8
研究概览
简要总结
The purpose of the study is to evaluate patient reported outcomes (PROs) in terms of health-related quality of life (HRQoL) among subjects with actinic keratosis (AK).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Actinic Keratosis (AK) of the face or scalp
- •Has clinically typical, visible, and discrete AK lesions
- •Considered as a potential candidate for tirbanibulin (Klisyri®) treatment to manage their AK
- •Willing to avoid excessive sun or ultraviolet (UV) exposure, and/or use relevant sunscreen protection and protective clothing during the study duration
- •Able to read and write English
- •Provide consent to participate in the study
- •Willing to comply with all study procedures and be available for the duration of the study
排除标准
- •Patients with any dermatological condition of the face or scalp that could interfere with the clinical evaluations.
- •Hypertrophic AK lesions, open wounds or suspected skin cancers within close 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.
研究组 & 干预措施
Tirbanibulin
Participants will receive tirbanibulin ointment 2.5 mg in 250 mg (single dose packet). The participants will be observed for 24 weeks to gather participant reported outcomes (PROs) and clinical profile.
干预措施: Tirbanibulin (Drug)
结局指标
主要结局
Change From Baseline in Domain Scores Using the Patient Reported Outcome Skindex-16 Instrument at Week 8
时间窗: Baseline, Week 8
Skindex-16 is a validated dermatological instrument to measure dermatology-specific Health-Related Quality of Life (HRQoL). The Skindex-16 consisted of 16 items that were divided into three domains: Symptoms (four items, range 0-24), Emotions (seven items, range 0-42), and Functioning (five items, range 0-30). Participant were asked to respond on how much their skin condition bothered them in the week prior to administration of the Skindex-16. Each item was scored on a scale ranged from 0 (never bothered) to 6 (always bothered), where higher score indicated continued/more botheration. Item scores are transformed to 0 to 100 scale, and domain scores are calculated as the average of the item scores comprising the domain. Net positive changes in respective subscale scoring indicates improvement in that particular Quality of life assessment (i.e., Symptoms, Emotions, Functioning), while net negative changes in scoring indicates decrease in that particular Quality of life assessment.
次要结局
- Percentage of Participants With Investigator Global Assement (IGA) Success at Week 8(At Week 8)