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NCT04023084 · ClinicalTrials.gov registry record · Phase 4
Response of Children With Atopic Dermatitis (Eczema) to Eucrisa
A Phase 4 study of Atopic Dermatitis and Eczema, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04023084: Completed Phase 4 study of Atopic Dermatitis and Eczema, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
NCT04023084 is a Phase 4 study of Atopic Dermatitis and Eczema that has completed, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 30 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04023084, a Phase 4 study of Atopic Dermatitis and Eczema, has completed, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to develop biomarkers to predict what medication is best for each child with atopic dermatitis (eczema). Participants will come in to Lurie Children's Allergy of Dermatology clinic for a skin examination and complete surveys. They will apply Eucrisa medication to their skin for 28 days before returning for a second and final skin examination and complete surveys. During these skin exams, tape will be placed on the skin and removed to collect skin cell samples. Photos will also be taken of the skin where tape was placed. There is an optional blood draw.
Primary Outcome
The baseline mean expression levels of biomarkers extracted from tape strips (TH2 (IL13, IL4R, CCL26), TH17/22 (IL36G), itch (ENKUR), epidermal genes (FLG, LOR and S100A9) and PDE4A will be compared in clinical "responder" versus "non-responder" groups. Groups will be defined by the primary clinical outcome of disease severity improvement by clinician assessment. Clinicians will assess disease severity by Investigator's Static Global Assessment (ISGA) and Eczema Area and Severity Index (EASI) sc
Conditions Studied
Interventions
- DRUG Crisaborole
Study Locations (1)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-10-03 |
| Est. Completion | 2022-02-11 |
| Phase | Phase 4 |
What the finished NCT04023084 record still lists
NCT04023084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Atopic Dermatitis appearing as the primary indexed condition, and to 1 intervention - of which Crisaborole is the first listed.
NCT04023084 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04023084 about?
NCT04023084 is a clinical study titled "Response of Children With Atopic Dermatitis (Eczema) to Eucrisa". The purpose of this study is to develop biomarkers to predict what medication is best for each child with atopic dermatitis (eczema). Participants will come in to Lurie Children's Allergy of Dermatology clinic for a skin examination and complete surveys. They will apply Eucrisa medication to their s...
What is the current status of trial NCT04023084?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2019-10-03. Estimated completion is 2022-02-11.
What conditions does trial NCT04023084 study?
This clinical trial studies the following conditions: Atopic Dermatitis, Eczema.
What interventions are being tested in trial NCT04023084?
The interventions under investigation include: Crisaborole (DRUG).
Who is sponsoring clinical trial NCT04023084?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04023084 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04023084's enrollment target sits among peer trials
30 120th of 150 higher than 25 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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