A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

NCT03011892 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2021-04-09

Study results available
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Summary

The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.

Conditions

Interventions

DRUG

Ruxolitinib 0.15% Cream QD

Ruxolitinib 0.15% cream QD

DRUG

Ruxolitinib 0.5% Cream QD

Ruxolitinib 0.5% cream QD

DRUG

Ruxolitinib 1.5% Cream QD

Ruxolitinib 1.5% cream QD

DRUG

Ruxolitinib 1.5% Cream BID

Ruxolitinib 1.5% cream BID

DRUG

Triamcinolone 0.1% Cream BID

Triamcinolone 0.1% cream BID

DRUG

Vehicle Cream BID

Vehicle cream BID

Sponsors & Collaborators

Principal Investigators

  • Michael Kuligowski, MD · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-09
Primary Completion
2018-01-10
Completion
2018-03-12
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

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 NCT03011892 on ClinicalTrials.gov