ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis

Clinical Trial ID: NCT03645057

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 5 to 12 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.

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.


Criteria

Inclusion Criteria: Pediatric Subjects: 1. Male and female subjects of inclusive ages of 5 to 12 years at screening visit. 2. Diagnosis of ≤moderate atopic dermatitis or eczema (ISGA 2 or 3 and ≥5% BSA, excluding scalp). 3. If subject is taking or prescribed antihistamines, subject must be on stable dose of antihistamines. 4. Caregiver (i.e., adult parent or guardian) must agree to participate in the study with the patient. 5. Subject must be able to read and speak English. 6. 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 <5 years old or >12 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.

  • Start Date

    2019-02-20

  • Last Updated

    2019-03-11

  • Sponsor

    University of Rochester

  • Condition Name

    Atopic Dermatitis

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