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NCT03356977 · ClinicalTrials.gov registry record · Phase 4
A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
A Phase 4 study of Atopic Dermatitis, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 137
- Enrollment target
- 20
- Study locations
NCT03356977: Completed Phase 4 study of Atopic Dermatitis, sponsored by Pfizer.
NCT03356977 is a Phase 4 study of Atopic Dermatitis that has completed, run by Pfizer. The registered enrollment target is 137 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03356977, a Phase 4 study of Atopic Dermatitis, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 137 participants
- Enrollment target
- 20
- Study locations
Study Summary
This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.
Primary Outcome
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between fir
Conditions Studied
Interventions
- DRUG Crisaborole ointment 2%
Study Locations (20)
California
- Rady Children's Hospital - San Diego/University of California, San Diego - San Diego
- Rady Children's Hospital - San Diego
- University of California, San Francisco - San Francisco
Texas
- DermResearch, Inc. - Austin
- Texas Dermatology and Laser Specialists - San Antonio
Utah
- Tanner Clinic - Layton
- Jordan Valley Dermatology Center - West Jordan
Virginia
- PI-Coor Clinical Research, LLC - Burke
- Pediatric Associates of Charlottesville, PLC - Charlottesville
Arkansas
- Burke Pharmaceutical Research - Hot Springs
Colorado
- IMMUNOe Research Centers - Thornton
Florida
- Baumann Cosmetic and Research Institute - Miami
Kentucky
- DS Research - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2018-01-16 |
| Est. Completion | 2019-04-12 |
| Phase | Phase 4 |
What the finished NCT03356977 record still lists
NCT03356977 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 1 intervention - of which Crisaborole ointment 2% is the first listed.
NCT03356977 names 20 study sites across 15 states, led by California, Texas, Utah.
Frequently Asked Questions
What is clinical trial NCT03356977 about?
NCT03356977 is a clinical study titled "A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis". This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.
What is the current status of trial NCT03356977?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 137 participants. The study started on 2018-01-16. Estimated completion is 2019-04-12.
What conditions does trial NCT03356977 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT03356977?
The interventions under investigation include: Crisaborole ointment 2% (DRUG).
Who is sponsoring clinical trial NCT03356977?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03356977 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Kentucky. 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 NCT03356977's enrollment target sits among peer trials
137 76th of 150 higher than 75 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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