ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis

• Status: Completed
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: Tacrolimus

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.