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NCT04040192 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 620
- Enrollment target
NCT04040192: Completed Phase 3 study, sponsored by Pfizer.
NCT04040192 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 620 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04040192, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 620 participants
- Enrollment target
Study Summary
This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.
Primary Outcome
The duration of flare-free maintenance was the time from randomization to the last Investigator's Static Global Assessment (ISGA) and was right censored, if an intercurrent event (eg, death, dropout, loss to follow up, or end of study) occurred before the first flare. When a flare occurred first, the duration of flare free maintenance was the time from randomization to the first flare and was not censored. Duration of flare free maintenance was estimated using the Kaplan-Meier method.
Interventions
- DRUG Vehicle
- DRUG Crisaborole 2%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 620 participants |
| Start Date | 2019-09-12 |
| Est. Completion | 2022-01-19 |
| Phase | Phase 3 |
What the finished NCT04040192 record still lists
NCT04040192 is an interventional study that assigns participants to a tested intervention. The registered 620 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT04040192 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04040192 about?
NCT04040192 is a clinical study titled "A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis". This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.
What is the current status of trial NCT04040192?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 620 participants. The study started on 2019-09-12. Estimated completion is 2022-01-19.
What interventions are being tested in trial NCT04040192?
The interventions under investigation include: Vehicle (DRUG), Crisaborole 2% (DRUG).
Who is sponsoring clinical trial NCT04040192?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04040192's enrollment target sits among peer trials
620 589th of 2000 higher than 1,410 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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