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NCT03539601 · ClinicalTrials.gov registry record · Phase 4
A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD
A Phase 4 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 4
- Development phase
- 237
- Enrollment target
NCT03539601 is a Phase 4 study that was terminated before completion, run by Pfizer. The registered enrollment target is 237 participants.
The verdict
NCT03539601, a Phase 4 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 237 participants
- Enrollment target
Study Summary
This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD. A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to \<18 years old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID will also be conducted at select sites.
Interventions
- DRUG Crisaborole ointment, 2%
- DRUG Hydrocortisone butyrate cream, 0.1%
- DRUG Pimecrolimus cream, 1%
- DRUG Crisaborole Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2018-04-27 |
| Est. Completion | 2020-12-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03539601
The ClinicalTrials.gov registry entry for NCT03539601 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 237 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Crisaborole ointment, 2% is the first listed.
NCT03539601 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03539601 about?
NCT03539601 is a clinical study titled "A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD". This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD. A Sub-Study of Optical Coherence Tomography...
What is the current status of trial NCT03539601?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 237 participants. The study started on 2018-04-27. Estimated completion is 2020-12-11.
What interventions are being tested in trial NCT03539601?
The interventions under investigation include: Crisaborole ointment, 2% (DRUG), Hydrocortisone butyrate cream, 0.1% (DRUG), Pimecrolimus cream, 1% (DRUG), Crisaborole Vehicle (DRUG).
Who is sponsoring clinical trial NCT03539601?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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