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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: Completed Phase 3 study of Atopic Dermatitis, sponsored by University of Rochester.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This is a patient-reported outcome measure for Itch in pediatric patients that consists of 8 fixed items items, spanning four domains (general, activity, mood/sleep, and scratching behavior). Each item is scored on using 1 = No Itch, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very Severe. The range of the scale is 1 to 5 with higher numbers indicating worse outcome. A total score, representing overall itch-related quality of life, is scored by taking the average (i.e., divide by 8) of the sum o
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 |
What the finished NCT03645057 record still lists
NCT03645057 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (85% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Atopic Dermatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03645057's enrollment target sits among peer trials
92 88th of 150 higher than 62 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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