MedTrace Logo

A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD

NCT03539601 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2022-01-10

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Crisaborole ointment, 2%

Applied twice a day (BID)

DRUG

Hydrocortisone butyrate cream, 0.1%

Applied BID

DRUG

Pimecrolimus cream, 1%

Applied BID

DRUG

Crisaborole Vehicle

Applied BID

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2020-12-11
Completion
2020-12-11
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Italy
  • Poland
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT03539601 on ClinicalTrials.gov