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ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis

NCT03645057 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-10-31

Study results available
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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.

Conditions

Interventions

DRUG

Crisaborole

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.

DRUG

Tacrolimus 0.03% Ointment

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.

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Julie R Wolf, PhD, MPH · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2021-08-01
Completion
2021-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03645057 on ClinicalTrials.gov