NCT00560378

Long-term Safety of Protopic in Atopic Eczema

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 789 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Dermatitis, Atopic
• Eczema, Atopic

Interventions

Type	Name	Description
DRUG	Tacrolimus ointment 0.1%	Topical

Timeline

• Start date: 1998-06-01
• Completion: 2005-06-01
• First posted: 2007-11-19
• Last updated: 2014-09-18

Locations

41 sites across 12 countries: Belgium, Denmark, Finland, France, Germany, Hungary, Ireland, Latvia, Netherlands, Poland, Spain, United Kingdom