Long-term Safety of Protopic in Atopic Eczema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00560378
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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%

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Eczema, Atopic Drug: Tacrolimus ointment 0.1% Phase 3

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  (Clinical Trial)
Actual Enrollment : 789 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term, Open Label, Noncomparative Study to Evaluate the Safety of 0.1% Tacrolimus (FK506) Ointment for Treatment of Atopic Dermatitis
Study Start Date : June 1998
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tacrolimus Ointment 0.1% Drug: Tacrolimus ointment 0.1%
Other Name: Protopic

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 4 Years ]

Secondary Outcome Measures :
  1. Haematology and biochemistry parameters and vital signs [ Time Frame: 4 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00560378

  Show 42 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Central Contact Astellas Pharma GmbH

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00560378     History of Changes
Other Study ID Numbers: FG-506-06-21
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Astellas Pharma Inc:
Administration, topical
Drug safety

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action