Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

September 17, 2014 updated by: Astellas Pharma Inc

Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Children"

A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

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

  • Belgium
      • Bruxelles, Belgium
  • Czech Republic
      • Brno, Czech Republic
      • Praha, Czech Republic
        • 3 Sites
  • Finland
      • Helsinki, Finland
  • France
      • Nantes, France
      • Paris, France
  • Germany
      • Dusseldorf, Germany
      • Frankfurt, Germany
      • Kiel, Germany
      • Mahlow, Germany
  • Hungary
      • Budapest, Hungary
  • Italy
      • Bergamo, Italy
      • Parma, Italy
      • Roma, Italy
  • Netherlands
      • Amsterdam, Netherlands
      • Groningen, Netherlands
      • Nijmegen, Netherlands
      • Utrecht, Netherlands
  • Portugal
      • Porto, Portugal
  • Spain
      • Barcelona, Spain
  • United Kingdom
      • Birmingham, United Kingdom
      • London, United Kingdom

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 to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patient of any ethnic group
  • Patient was at least 2-15 years old and suffered from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3)

Exclusion Criteria:

  • Patient had a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
  • Patient had a clinically significant skin infection on the affected (and to be treated) area

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: 1
Drug: tacrolimus ointment
Topical application
Other Names:
  • Protopic®
  • FK506 ointment
Placebo Comparator: 2
Drug: Placebo ointment
Topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of exacerbations of atopic dermatitis requiring intervention.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first exacerbation requiring intervention; exacerbation treatment days, periods and time to first exacerbation; physician and patient assessment of affected area, treatment response; quality of life; global response.
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Investigators

  • Principal Investigator: Use Central Contact, Universitätsklinikum Frankfurt Zentrum für Dermatologie

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

June 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

May 30, 2007

First Submitted That Met QC Criteria

May 30, 2007

First Posted (Estimate)

May 31, 2007

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

  • FG-506-06-41

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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