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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%
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus Ointment 0.1% | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus ointment 0.1% | Drug | Topical |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 4 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Haematology and biochemistry parameters and vital signs | 4 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18637898 | Background | Reitamo S, Rustin M, Harper J, Kalimo K, Rubins A, Cambazard F, Brenninkmeijer EE, Smith C, Berth-Jones J, Ruzicka T, Sharpe G, Taieb A; 0.1% Tacrolimus Ointment Long-term Follow-up Study Group. A 4-year follow-up study of atopic dermatitis therapy with 0.1% tacrolimus ointment in children and adult patients. Br J Dermatol. 2008 Sep;159(4):942-51. doi: 10.1111/j.1365-2133.2008.08747.x. Epub 2008 Jul 15. |
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| Aarhus |
| Denmark |
| Helsinki | Finland |
| Tampere | Finland |
| Turku | Finland |
| Bordeaux | France |
| Brest | France |
| Gaël | France |
| Lyon | France |
| Nantes | France |
| Paris | France |
| Pessac | France |
| Quimper | France |
| Saint-Etienne | France |
| Tours | France |
| Bonn | Germany |
| Düsseldorf | Germany |
| Erlangen | Germany |
| Freiburg im Breisgau | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| München | Germany |
| Münster | Germany |
| Tübingen | Germany |
| Szeged | Hungary |
| Cork | Ireland |
| Dublin | Ireland |
| Riga | Latvia |
| Amsterdam | Netherlands |
| Warsaw | Poland |
| Barcelona | Spain |
| Madrid | Spain |
| Seville | Spain |
| Cardiff | United Kingdom |
| Coventry | United Kingdom |
| Lancaster | United Kingdom |
| Leicester | United Kingdom |
| Liverpool | United Kingdom |
| London | United Kingdom |
| Manchester | United Kingdom |
| Southhampton | United Kingdom |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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