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%

Long-term Safety of Protopic in Atopic Eczema

Dermatitis, Atopic

Eczema, Atopic

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).

Long-term Safety of Protopic in Atopic Eczema

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?