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Phosphodiesterase-4 (PDE-4) Inhibitor
Atopic Dermatitis Group for Atopic Dermatitis
Phase 4
Waitlist Available
Led By Anna Fishbein, MD
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and day 28
Awards & highlights
Study Summary
This trial is testing whether a new eczema medication is effective and safe. It will also develop biomarkers to help predict which medication is best for each child with atopic dermatitis.
Eligible Conditions
- Atopic Dermatitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) and day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in expression levels of biomarkers in responder versus non responder groups
Secondary outcome measures
Changes in Quality of life (anxiety, depressive symptoms, fatigue, mobility, pain interference, peer relationships) as assessed by PROMIS Pediatric Profile 25 and Correlation of changes with clinical responsiveness and biomarker PDE4A expression levels
Changes in Quality of life (symptoms and feelings, leisure, school or holidays, personal relationships, sleep, treatment) as assessed by CDLQI and Correlation of Quality of life changes with clinical responsiveness and biomarker PDE4A expression levels
Correlation of TEWL with clinical responsiveness and biomarker PDE4A expression levels
Side effects data
From 2021 Phase 4 trial • 30 Patients • NCT035679803%
Facial Pain
3%
Headaches
100%
80%
60%
40%
20%
0%
Study treatment Arm
Topical Crisaborole 2%
Trial Design
1Treatment groups
Experimental Treatment
Group I: Atopic Dermatitis GroupExperimental Treatment1 Intervention
Receive crisaborole intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Crisaborole
2018
Completed Phase 4
~190
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,908,020 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
256 Previous Clinical Trials
5,187,850 Total Patients Enrolled
Anna Fishbein, MDPrincipal Investigator - Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H. Lurie Children's Hospital of Chicago, La Rabida Children's Hospital
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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