Long-term Safety of Protopic in Atopic Eczema

Phase 3

Completed

• Conditions: Eczema, Atopic; Dermatitis, Atopic
• Interventions: Drug: Tacrolimus ointment 0.1%

• Registration Number: NCT00560378
• Lead Sponsor: 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%

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 Timeline

• Study Start: 1998-06
• Study Completion: 2005-06
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-19
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 789

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus Ointment 0.1%	Tacrolimus ointment 0.1%	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	4 Years

Secondary Outcome Measures

Name	Time	Method
Haematology and biochemistry parameters and vital signs	4 Years