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

NCT04040192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2023-03-08

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Crisaborole 2%

Crisaborole ointment 2%

DRUG

Vehicle

Vehicle ointment

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-12
Primary Completion
2022-01-19
Completion
2022-01-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China
  • Israel
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04040192 on ClinicalTrials.gov