Long-term Safety of Protopic in Atopic Eczema

September 17, 2014 updated by: Astellas Pharma Inc

A Long-term, Open Label, Noncomparative Study to Evaluate the Safety of 0.1% Tacrolimus (FK506) Ointment for Treatment of Atopic Dermatitis

Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1%

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A long-term, multi-centre, open label, non-comparative phase III study in patients with atopic dermatitis. All centres in Europe which have participated or are still participating in the FG-506-06-12, FG-506-06-18 or FG-506-06-19, FG-506-06-22 or FG-506-06-23 studies will be offered a participation in the protocol. Only patients enrolled by those centres for the above mentioned studies, who have received at least one dose of study medication can be enrolled. Tacrolimus ointment 0.1% will be administered until clearance of the skin occurs. Treatment is restarted after signs and symptoms reoccur. Safety will be assessed from adverse events reported by the patient/parent/guardian or observed by the investigator at the site of application and elsewhere. The safety evaluation will include monitoring of routine hematology and serum chemistry parameters at Baseline/Day 1, Week 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and/or at the end of the study (End-of-Study Visit).

Study Type

Interventional

Enrollment (Actual)

789

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
      • Brussels, Belgium
      • Bruxelles, Belgium
  • Denmark
      • Aarhus, Denmark
  • Finland
      • Helsinki, Finland
      • Tampere, Finland
      • Turku, Finland
  • France
      • Bordeaux, France
      • Brest, France
      • Gael, France
      • Lyon, France
      • Nantes, France
      • Paris, France
      • Pessac, France
      • Quimper, France
      • Saint Etienne, France
      • Tours, France
  • Germany
      • Bonn, Germany
      • Duesseldorf, Germany
      • Erlangen, Germany
      • Freiburg, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Muenchen, Germany
      • Muenster, Germany
      • Tuebingen, Germany
  • Hungary
      • Szeged, Hungary
  • Ireland
      • Cork, Ireland
      • Dublin, Ireland
  • Latvia
      • Riga, Latvia
  • Netherlands
      • Amsterdam, Netherlands
  • Poland
      • Warszawa, Poland
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Sevilla, Spain
  • United Kingdom
      • Cardiff, United Kingdom
      • Coventry, United Kingdom
      • Lancaster, United Kingdom
      • Leicester, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Southhampton, 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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Every patient who has participated in the FG-506-06-12, FG-506-06-18, FG-506-06-19, FG-506-06-22 or FG-506-06-23 study, and has received at least one dose of study medication
  • Patient is likely to benefit from further treatment with Tacrolimus (FK506) ointment in the opinion of the investigator
  • Patient has atopic dermatitis with Body surface involvement between 5% and 60% for patients with the age of 2 years to 15 years (not having reached their 16th birthday) and between 5% and 100% for patients with 16 years of age or older

Exclusion Criteria:

  • Patient has an infection requiring treatment
  • Patient is known to be HIV positive
  • Patient has a systemic disease, including cancer or history of cancer or AIDS, which would contraindicate the use of Tacrolimus (FK506) ointment

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tacrolimus Ointment 0.1%
Drug: Tacrolimus ointment 0.1%
Topical
Other Names:
  • Protopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: 4 Years
4 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Haematology and biochemistry parameters and vital signs
Time Frame: 4 Years
4 Years

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Central Contact, Astellas Pharma GmbH

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, 1998

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

November 16, 2007

First Submitted That Met QC Criteria

November 16, 2007

First Posted (Estimate)

November 19, 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-506-06-21

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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