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ASPIRE: Treating Children With Atopic Dermatitis (Eczema)

Research Question:
How do topical medications for atopic dermatitis affect health and quality of life in children and their caregivers?

Basic Study Information

Purpose:
This study will monitor the effects of ointments, crisaborole and tacrolimus 0.03%, on patient-reported outcomes (PROs) and caregiver burden in children (ages 5 to 15 years) with 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.

Location: University of Rochester Dermatology
Study Reference #: 00073062

Lead Researcher (Principal Investigator)

Lead Researcher: Julie Wolf

Study Contact Information

Study Coordinator: Alicia Papilia
Phone: (585) 273-4195
Email: Alicia_Papalia@urmc.rochester.edu

Additional Study Details

Study Details:
This is an open-label, randomized, cross-sectional study to monitor the effects of crisaborole and tacrolimus 0.03% on patient-reported outcomes (PROs) and caregiver burden in children (ages 5 to 15 years, inclusive) with mild to 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. Children with mild to moderate atopic dermatitis (ages 5 to 15 years, inclusive) are eligible. Their parent or caregiver must also participate in the study with the child participant. The child will be randomized to tacrolimus 0.03% or crisaborole for their atopic dermatitis which they will use for 12 weeks. The study consists of 3 clinic visits over 12 weeks (baseline, 6 weeks, 12 weeks) during which the child's atopics dermatitis will be clinically assessed and the child and caregiver/parent will complete a questionnaire on an iPad. Subjects will be reimbursed for their participation in this study.

Number of Visits:  2 to 5
Parking:  Free
Transportation Coverage:  No
Reimbursement:  Yes
Payment Details:  Child participants will receive a $10 gift card at the end of each study visit for their participation. All adult caregiver subjects will be reimbursed $100 for completion of all study procedures. Payment will be prorated based on number of assessments completed in the study. Subjects will be paid $20 for completion of Baseline Assessment, $40 for completion of 6 Week Assessment, and $40 for completion of 12 Week Assessment. A check will be issued to the adult caregiver (i.e., caregiver) after completion of 12 Week Assessment or whenever their participation in the study has ended.

Learn More About These Conditions

More information about Dermatitis, Atopic

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