ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Caregiver Burden
Intervention: Crisaborole; Tacrolimus 0.03% Ointment
Intervention description: 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.
Intervention MeSH terms: Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 92.0
Sex: All
Minimum age: 2 Years
Maximum age: 15 Years
Healthy volunteers: No

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.
    

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.