NCT03645057

ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis

ASPIRE: DETERIMINING THE IMPACT OF CRISABOROLE (Eucrisa) AND TACROLIMUS 0.03% ON PATIENT-REPORTED OUTCOMES AND CAREGIVER BURDEN IN CHILDREN WITH ATOPIC DERMATITIS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Crisaborole	This topical ointment is FDA-approved to treat atopic dermatitis of moderate or less severity in children. Subjects will apply the topical ointment to all affected areas twice daily for 12 weeks.
DRUG	Tacrolimus 0.03% Ointment	This topical ointment is FDA-approved to treat atopic dermatitis in children. Subjects will apply the topical ointment to all affected areas twice daily for 12 weeks.

Timeline

• Start date: 2019-02-20
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2018-08-24
• Last updated: 2022-10-31
• Results posted: 2022-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study