Clinical trial NCT03645057: ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis
Official title: ASPIRE: DETERIMINING THE IMPACT OF CRISABOROLE (Eucrisa) AND TACROLIMUS 0.03% ON PATIENT-REPORTED OUTCOMES AND CAREGIVER BURDEN IN CHILDREN WITH ATOPIC DERMATITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 92
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Pediatric Subjects:

1. Male and female subjects of inclusive ages of 2 to 15 years (inclusive) at screening visit.
2. Diagnosis of ≤moderate atopic dermatitis or eczema (ISGA 2 or 3 and ≥3% BSA, excluding scalp).
3. If subject is taking or prescribed antihistamines, subject must be on stable dose of antihistamines.
4. If subject is taking or prescribed topical steroids, subject must be on stable dose of topical steroids.
5. 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.
6. 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.
7. 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:

1. Subject must be at least 18 years old and the parent or guardian of the eligible pediatric subject.
2. Subject must be able to read and speak English.
3. Subject must be able to give informed consent.

Exclusion Criteria:

1. Pediatric subjects \<2 years old or \>15 years old are not eligible for participation in this study.
2. Pediatric subjects with a diagnosis with another skin disease (i.e., not atopic dermatitis or eczema) are excluded to prevent confounding of results.
3. Pediatric subjects currently on systemic anti-inflammatory therapy for atopic dermatitis or other indication are excluded.
4. Caregiver subject \<18 years old are excluded.
5. Pediatric subject participation without caregiver participation is not allowed.

Primary outcomes:
measure: Mean Change in Children's PROMIS Pediatric Itch Short-Form
timeFrame: baseline to 12 weeks
measure: Mean Change in PROMIS Pain Interference-Children (Adaptive Test)
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Mean Change in Children's Dermatology Life Quality Index
timeFrame: baseline to 12 weeks
measure: Mean Change in Children's Sleep Habits Questionnaire
timeFrame: Baseline to 12 Weeks
measure: Mean Change in PROMIS Anxiety-children (Adaptive Test)
timeFrame: baseline to 12 weeks
measure: Mean Change in PROMIS Depressive Symptoms-Pediatric (Adaptive Test)
timeFrame: baseline to 12 weeks
measure: Mean Change in Children's Eczema Area & Severity Index (EASI)
timeFrame: baseline to 12 weeks
Other outcomes:
measure: Mean Change in Caregiver Burden Inventory
timeFrame: baseline to 12 weeks
measure: Mean Change in Family Dermatology Life Quality Index
timeFrame: baseline to 12 weeks
Locations:
city: Rochester
country: United States
facility: University of Rochester Dermatology
state: New York
Study officials:
affiliation: University of Rochester
name: Julie R Wolf, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: