Dermatitis, Atopic, Eczema, Atopic
Conditions
Keywords
Tacrolimus, Administration, topical, Drug safety, Adults, Children
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).
Interventions
Topical
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 4 Years |
Secondary
| Measure | Time frame |
|---|---|
| Haematology and biochemistry parameters and vital signs | 4 Years |
Countries
Belgium, Denmark, Finland, France, Germany, Hungary, Ireland, Latvia, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed