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NCT03645057 · ClinicalTrials.gov registry record · Phase 3
ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis
A Phase 3 study of Atopic Dermatitis, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 3
- Development phase
- 92
- Enrollment target
- 1
- Study location
NCT03645057 is a Phase 3 study of Atopic Dermatitis that has completed, run by University of Rochester. The registered enrollment target is 92 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03645057, a Phase 3 study of Atopic Dermatitis, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 92 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Crisaborole
- DRUG Tacrolimus 0.03% Ointment
Study Locations (1)
New York
- University of Rochester Dermatology - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2019-02-20 |
| Est. Completion | 2021-08-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03645057
The ClinicalTrials.gov registry entry for NCT03645057 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (85% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Crisaborole is the first listed.
NCT03645057 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03645057 about?
NCT03645057 is a clinical study titled "ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis". 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...
What is the current status of trial NCT03645057?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 92 participants. The study started on 2019-02-20. Estimated completion is 2021-08-01.
What conditions does trial NCT03645057 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT03645057?
The interventions under investigation include: Crisaborole (DRUG), Tacrolimus 0.03% Ointment (DRUG).
Who is sponsoring clinical trial NCT03645057?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03645057 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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