ASPIRE: DETERIMINING THE IMPACT OF CRISABOROLE (Eucrisa) AND TACROLIMUS 0.03% ON PATIENT-REPORTED OUTCOMES AND CAREGIVER BURDEN IN CHILDREN WITH ATOPIC DERMATITIS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Mean Change in Children's PROMIS Pediatric Itch Short-Form
研究概览
简要总结
This is an open-label, randomized, cross-sectional study to monitor the effects of crisaborole and tacrolimus 0.03% on patient-reported outcomes and caregiver burden in children (ages 2 to 15 years, inclusive) with ≤ moderate atopic dermatitis over a 12 week period of time. The goal of this study is to detect changes in PROs and caregiver burden during treatment for atopic dermatitis of moderate or less severity. The study design will allow us to correlate PROs and caregiver burden with treatment response and disease improvement in children.
详细描述
Atopic dermatitis (AD) is a common, chronic skin disease affecting 20% of children and 10% of adults worldwide (1-3). Children with AD often develop the disease within the first five years of life, which is a critical time for physical and psychosocial development (4). AD impacts an individual's physical, mental, and social health. Anxiety, itch, sleep disturbance, and depression have been associated with low quality of life scores. Childhood AD also affects the emotional, financial, physical, and social well-being of parents or caregivers (4). Individuals caring for a child with AD report sleep deprivation, poor social support, and stress about parenting (1, 4). Utilizing patient-reported outcomes (PROs) in clinic can provide meaningful data to monitor disease activity and response to different interventions, with the ultimate goal to improve quality of life for the patient and their family members or caregivers. Additionally, PROs can help us better understand the burden of AD. It is still unclear which PROs are most relevant for atopic dermatitis. This study will evaluate the utility of several PROs to monitor response to two different topical ointments, crisaborole (Eucrisa™) and tacrolimus 0.03%, to better understand the impact of these two non-steroidal topical treatments on overall health of children with AD of moderate or less severity and their caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric Subjects:
- •Male and female subjects of inclusive ages of 2 to 15 years (inclusive) at screening visit.
- •Diagnosis of ≤moderate atopic dermatitis or eczema (ISGA 2 or 3 and ≥3% BSA, excluding scalp).
- •If subject is taking or prescribed antihistamines, subject must be on stable dose of antihistamines.
- •If subject is taking or prescribed topical steroids, subject must be on stable dose of topical steroids.
- •If taking a systemic anti-inflammatory medication for atopic dermatitis or other condition, subject must be on stable dose of the systemic anti-inflammatory medication for six weeks prior to enrollment.
- •If subject is currently taking or prescribed tacrolimus or crisaborole, or other steroid-sparring medication, subject must agree to two week (i.e., 14 days) washout period prior to randomization and Baseline Assessment for study.
- •Caregiver (i.e., adult parent or guardian) must agree to participate in the study with the patient.
- •e) Subject must be able to read and speak English. f) Subject ages ≥8 years, is able to give assent.
- •Caregiver Subjects:
- •Subject must be at least 18 years old and the parent or guardian of the eligible pediatric subject.
- •Subject must be able to read and speak English.
- •Subject must be able to give informed consent.
排除标准
- •Pediatric subjects <2 years old or >15 years old are not eligible for participation in this study.
- •Pediatric subjects with a diagnosis with another skin disease (i.e., not atopic dermatitis or eczema) are excluded to prevent confounding of results.
- •Pediatric subjects currently on systemic anti-inflammatory therapy for atopic dermatitis or other indication are excluded.
- •Caregiver subject <18 years old are excluded.
- •Pediatric subject participation without caregiver participation is not allowed.
研究组 & 干预措施
Tacrolimus 0.03%
The topical treatment will be applied to all affected areas twice daily for 12 weeks.
干预措施: Tacrolimus 0.03% Ointment (Drug)
Crisaborole
The topical treatment will be applied to all affected areas twice daily for 12 weeks.
干预措施: Crisaborole (Drug)
结局指标
主要结局
Mean Change in Children's PROMIS Pediatric Itch Short-Form
时间窗: baseline to 12 weeks
This is a patient-reported outcome measure for Itch in pediatric patients that consists of 8 fixed items items, spanning four domains (general, activity, mood/sleep, and scratching behavior). Each item is scored on using 1 = No Itch, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very Severe. The range of the scale is 1 to 5 with higher numbers indicating worse outcome. A total score, representing overall itch-related quality of life, is scored by taking the average (i.e., divide by 8) of the sum of all 8 items. Therefore, total itch scores range between 1 and 5, with higher scores indicating worse impact of itch on quality of life. The measure was completed electronically on an iPad using REDCap.
Mean Change in PROMIS Pain Interference-Children (Adaptive Test)
时间窗: baseline to 12 weeks
This is a patient reported outcome measure for pain interference in pediatric patients. This is a computer adaptive test consisting of 4-12 questions related to how pain interferes with daily activities. The number of questions a patient answers depends on how he or she answers each question. The overall domain score ranges from 0 to100 with a score of 50 representing the average score for the general population. Higher scores indicate greater pain interference. A score above 55 is considered "clinically significant" for each domain. A score change of 5 or more is considered a clinically important change in domain severity. This measure was completed electronically on an iPad using REDCap.
次要结局
- Mean Change in Children's Dermatology Life Quality Index(baseline to 12 weeks)
- Mean Change in Children's Sleep Habits Questionnaire(Baseline to 12 Weeks)
- Mean Change in PROMIS Anxiety-children (Adaptive Test)(baseline to 12 weeks)
- Mean Change in PROMIS Depressive Symptoms-Pediatric (Adaptive Test)(baseline to 12 weeks)
- Mean Change in Children's Eczema Area & Severity Index (EASI)(baseline to 12 weeks)
研究者
Julie Ryan Wolf
Associate Professor of Dermatology & Radiation Oncology
University of Rochester