A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis

September 17, 2014 updated by: Astellas Pharma Inc

A Multi-Center Study to Assess the Impact of Topical Corticosteroids on the Safety and Efficacy of Protopic Ointment in the Short-Term Treatment of Atopic Dermatitis and to Assess Protopic in the Long-term Management of Atopic Dermatitis

The purpose of the study is to determine the impact of topical corticosteroids on the safety and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo in the long-term management of Atopic Dermatitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study includes an interim short-term, open label period. Patients could also receive a second course of open label treatment dependent on disease exacerbation.

Study Type

Interventional

Enrollment (Actual)

410

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Investigational Site
    • California
      • Irvine, California, United States, 92697
        • Investigational Site
      • Loma Linda, California, United States, 92354
        • Investigational Site
      • San Diego, California, United States, 92123
        • Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06519
    • Florida
      • Miami, Florida, United States, 33136
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
      • Chicago, Illinois, United States, 60614
        • Investigational Site
      • Chicago, Illinois, United States, 60611
        • Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Maryland
      • Baltimore, Maryland, United States, 21205
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Investigational Site
      • Detroit, Michigan, United States, 48202
        • Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Investigational Site
    • New York
      • New York, New York, United States, 10029
        • Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97201
        • Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19115
        • Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Investigational Site
      • Dallas, Texas, United States, 75390
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must have Atopic Dermatitis
  • Patient must be at least 2 years of age

Exclusion Criteria:

  • Patient is pregnant or breast feeding an infant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1A
Drug: Protopic
topical
Other Names:
  • FK506 ointment
  • tacrolimus ointment
Active Comparator: 1B
Drug: Corticosteroid
topical
Experimental: 2
Open label
Drug: Protopic
topical
Other Names:
  • FK506 ointment
  • tacrolimus ointment
Experimental: 3A
Drug: Protopic
topical
Other Names:
  • FK506 ointment
  • tacrolimus ointment
Placebo Comparator: 3B
Drug: placebo
topical
Experimental: 4
Open label
Drug: Protopic
topical
Other Names:
  • FK506 ointment
  • tacrolimus ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients reporting cutaneous adverse events overall
Time Frame: Day 4 through end of study
Day 4 through end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

March 25, 2005

First Submitted That Met QC Criteria

March 25, 2005

First Posted (Estimate)

March 28, 2005

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-04-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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