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Long-term tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis and prevent delay & reduce flares
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus ointment | Drug | Topical application |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of exacerbations of atopic dermatitis requiring intervention. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first exacerbation requiring intervention; exacerbation treatment days, periods and time to first exacerbation; physician and patient assessment of affected area, treatment response; quality of life; global response | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians Universität | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck | Austria | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18592619 | Background | Wollenberg A, Reitamo S, Girolomoni G, Lahfa M, Ruzicka T, Healy E, Giannetti A, Bieber T, Vyas J, Deleuran M; European Tacrolimus Ointment Study Group. Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy. 2008 Jul;63(7):742-50. | |
| 18782316 | Background | Wollenberg A, Sidhu MK, Odeyemi I, Dorsch B, Koehne-Volland R, Schaff M, Ehlken B, Berger K. Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol. 2008 Dec;159(6):1322-30. doi: 10.1111/j.1365-2133.2008.08807.x. Epub 2008 Sep 6. |
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| Placebo ointment | Drug | Topical application |
|
| Brussels |
| Belgium |
| Edegem | Belgium |
| Prague | Czechia |
| Aarjus | Denmark |
| Helsinki | Finland |
| Paris | France |
| Saint-Etienne | France |
| Bonn | Germany |
| Dresden | Germany |
| Düsseldorf | Germany |
| München | Germany |
| Modena | Italy |
| Roma | Italy |
| Amsterdam | Netherlands |
| Utrecht | Netherlands |
| Almada | Portugal |
| Barcelona | Spain |
| Madrid | Spain |
| Geneva | Switzerland |
| Cardiff | 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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