ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Caregiver Burden
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Crisaborole; Tacrolimus 0.03% Ointment
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Eucrisa; Protopic
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment