CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 92 enrolled
Drug / intervention
Crisaborole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03645057
NCT03645057Phase 3Completed
CompareCT.gov

ASPIRE: DETERIMINING THE IMPACT OF CRISABOROLE (Eucrisa) AND TACROLIMUS 0.03% ON PATIENT-REPORTED OUTCOMES AND CAREGIVER BURDEN IN CHILDREN WITH ATOPIC DERMATITIS

University of Rochester·interventional·Posted Aug 24, 2018·Updated Oct 31, 2022

In Brief

A Phase 3 clinical trial evaluating Crisaborole and Tacrolimus 0.03% Ointment for Atopic Dermatitis. Completed, enrolled 92 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtopic Dermatitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 24, 2018
Enrollment StartFeb 20, 2019
Primary CompletionAug 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.9 years ago

Interventions

Crisaboroledrug

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.

Tacrolimus 0.03% Ointmentdrug

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.