ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis
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.
Timeline
- Start
- 2019-02-20
- Primary completion
- 2021-08-01
- Completion
- 2021-08-01
Outcome
Missed primary endpoint
registry analysis (superiority test); Crisaborole vs Tacrolimus 0.03%; p = 0.433; Wilcoxon rank sum test NCT03645057 ↗
registry analysis (superiority test); Crisaborole vs Tacrolimus 0.03%; p = 0.836; Wilcoxon rank sum test NCT03645057 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crisaborole | Small molecule | — | Topical |
| Comparator | Tacrolimus | Small molecule | 0.03 % | Topical |