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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 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.

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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.

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

FieldValue
Enrollment Target 137 participants
Start Date 2018-01-16
Est. Completion 2019-04-12
Phase Phase 4

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT03356977

The ClinicalTrials.gov registry entry for NCT03356977 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (78% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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