drugset / Trial / NCT03645057

ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis

NCT03645057

Phase 3 Completed 92 enrolled University of Rochester
RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Crisaborole Small molecule Topical
Comparator Tacrolimus Small molecule 0.03 % Topical

Indications