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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: Clinical Trial Phase 4 study, sponsored by Pfizer.
NCT03539601 is a Phase 4 study that was terminated before completion, run by Pfizer. The registered enrollment target is 237 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
EASI quantifies severity of participant's AD (excluded scalp) based on lesion severity and percent (%) body surface area (%BSA) affected. Lesion severity included erythema (E), induration/papulation (I), excoriation (Ex), lichenification (L) scored for 4 regions (head and neck \[h\], upper limbs \[u\], trunk \[t\] \[including axillae, groin\], lower limbs \[l\] \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) based upon %BSA with AD in bod
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 |
Why NCT03539601 stopped before completion
NCT03539601 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 4 interventions - of which Crisaborole ointment, 2% is the first listed.
NCT03539601 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03539601's enrollment target sits among peer trials
237 367th of 2000 higher than 1,634 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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