NCT05741294已完成4 期
Open Phase IV Study to Assess the Impact of Tirbanibulin on the Wellbeing of Patients With Actinic Keratoses (TIRBASKIN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 30
- 主要终点
- Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57
研究概览
简要总结
The purpose of the study is to assess treatment satisfaction on Day 57 in participants with Actinic Keratoses (AK) of the face or scalp following treatment with tirbanibulin ointment 1 percent (%) administered once daily for 5 consecutive days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent.
- •Males or females aged greater than or equal to (>=)18 years.
- •Diagnosis of clinically typical AK in one contiguous area on the face or scalp with a treatment area of 25^cm2 containing 4-8 AK lesions.
- •Participants not previously treated for AK on the current treatment area of the face or scalp in the last 6 months. However, previous AK treatment in other small areas (up to 25^cm2) in the last greater than >1 to less than <6 months is allowed.
- •Females must be postmenopausal (A female said to be postmenopausal should be >45 years of age with at least 12 months of amenorrhea), surgically sterile (by hysterectomy, bilateral oophorectomy, or tubal ligation); or, if of child-bearing potential, must be using highly effective contraception for at least 30 days or 1 menstrual cycle, whichever is longer, prior to study treatment and must agree to continue to use highly effective contraception for at least 30 days following their last dose of study treatment. Highly effective contraception includes oral hormonal contraceptives, hormonal contraceptive intercourse.
- •Sexually active males who have not had a vasectomy, and whose partner is reproductively capable, must agree to use barrier contraception from Screening through 90 days after their last dose of study treatment.
- •All participants must agree not to donate sperm or eggs from screening through 90 days following their last dose of study treatment.
- •Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0 prior to dose administration.
- •Willing to avoid excessive sun or UV (ultraviolet light) light exposure to the face or scalp.
排除标准
- •Clinically atypical and/or rapidly changing AK lesions.
- •Location of the treatment area is within 5 cm of an incompletely healed wound or a suspected basal cell carcinoma (BCC)/squamous cell carcinoma (SCC).
- •Skin disease (e.g., atopic dermatitis, psoriasis, eczema) or condition (e.g., open wounds, scarring) in the treatment area that might interfere with the study results or suppose an unacceptable risk.
- •History of sensitivity to any of the ingredients in the tirbanibulin formulation.
- •Participated in a clinical trial during which an investigational study medication was administered within 30 days or 5 half-lives of the investigational product, whichever is longer, before dosing.
- •Participants with a history of tirbanibulin treatment for AK lesions and participants who are currently on tirbanibulin treatment for AK lesions.
- •Use of immunomodulators (e.g., azathioprine), cytotoxic drugs (e.g., cyclophosphamide, vinblastine, chlorambucil, methotrexate) or interferons/ interferon inducers and systemic immunosuppressive agents (e.g., cyclosporine, prednisone, methotrexate, alefacept, infliximab) within 4 weeks prior to the Screening visit, except for organ transplant recipients under stable immunosuppressive therapy for 6 months.
- •Use of systemic retinoids (e.g., isotretinoin, acitretin, bexarotene) within 6 months prior to the Screening visit.
- •Use of the following therapies and/or medications within 2 weeks prior to the Screening Visit:
- •Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing) within the treatment area or within 2 cm of the selected treatment area
- •Acid-containing therapeutic products (e.g., salicylic acid or fruit acids, such as alpha- and beta-hydroxyl acids and glycolic acids), topical retinoids, or light chemical peels within the treatment area or within 2 cm of the selected treatment area
- •Topical salves (nonmedicated/nonirritant lotion and cream are acceptable) or topical steroids within the treatment area or within 2 cm of the selected treatment area; artificial tanners within the treatment area or within 5 cm of the selected treatment area.
- •Females who are pregnant or nursing.
研究组 & 干预措施
Tirbanibulin 2.5 milligrams (mg) ointment
Experimental
Participants will apply tirbanibulin ointment- topically at a dose of 2.5 mg once daily for 5 consecutive days- on the face or scalp.
干预措施: Tirbanibulin 2.5 mg ointment (Drug)
结局指标
主要结局
Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Total Score of Each Components at Day 57
时间窗: At Day 57
TSQM-9 was a 9-item clinically validated psychometric instrument developed from the TSQM 1.4. TSQM-9 measures participant satisfaction with the medication in 3 domains: Effectiveness, convenience, and global satisfaction. The scores were computed by adding items for each domain, i.e., 1 to 3 for effectiveness, 4 to 6 for convenience, and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) x 3 items = 18 for effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100, with higher scores indicating greater satisfaction for that domain. A positive change from baseline indicates improvement.
次要结局
- Change From Baseline in Skindex-16 Questionnaire Symptoms Sub-Score at Day 57(Baseline, Day 57)
- Percentage of Participants With Organoleptic Properties of Tirbanibulin Assessed on a Likert Scale at Day 8(At Day 8)
- Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM 1.4) Components Scores at Day 57(At Day 57)
- Percentage of Patients Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 9) at Day 57(At Day 57)
- Percentage of Physician Who Answered Expert Panel Questionnaire (EPQ) (Question 1 to Question 10) at Day 57(At Day 57)
- Percentage of Participants With Complete (100%) Clearance of All Lesions Within the Application Area at Day 57(At Day 57)
- Percentage of Participants With Partial Clearance (Reduction of at Least >=75% to <100%) of All Lesions Within the Application Area at Day 57(At Day 57)
- Percent Change From Baseline in Mean Number of Old and New AK Lesions at Day 57(At Day 57)
- Percentage of Participants by Olsen Characterization at Baseline and Day 57(Baseline (Day 0) and Day 57)
- Percentage of Participants Who Performed Line-field Confocal Optical Coherence Tomography (LC-OCT) for Clinical and Sub Clinical Lesions Assessment at Each Timepoint(Baseline, Day 8, Day 15, Day 29, and Day 57)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Severity of TEAEs(From start of study administration up to Day 57)
研究者
研究点 (30)
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