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A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus ointment | Drug | topical |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Eczema Area and Severity Index (EASI) | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Atopic Dermatitis Assessment (IGADA) | 6 Weeks | |
| Patient's evaluation of itch | 6 Weeks | |
| Body surface area affected |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use central contact | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35205 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20107727 | Background | Kirsner RS, Heffernan MP, Antaya R. Safety and efficacy of tacrolimus ointment versus pimecrolimus cream in the treatment of patients with atopic dermatitis previously treated with corticosteroids. Acta Derm Venereol. 2010;90(1):58-64. doi: 10.2340/00015555-0748. | |
| 15858471 | Background | Paller AS, Lebwohl M, Fleischer AB Jr, Antaya R, Langley RG, Kirsner RS, Blum RR, Rico MJ, Jaracz E, Crowe A, Linowski GJ; US/Canada Tacrolimus Ointment Study Group. Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: results from 3 randomized, comparative studies. J Am Acad Dermatol. 2005 May;52(5):810-22. doi: 10.1016/j.jaad.2004.12.038. |
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| pimecrolimus cream | Drug | topical |
|
|
| 6 Weeks |
| San Francisco |
| California |
| 94118 |
| United States |
| Kansas City | Kansas | 66160 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| St Louis | Missouri | 63110 | United States |
| New York | New York | 10029 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Dallas | Texas | 75230 | United States |
| San Antonio | Texas | 78229 | United States |
| Salt Lake City | Utah | 84124 | United States |
| Norfolk | Virginia | 23507 | United States |
| Halifax | Nova Scotia | B3H 1V7 | Canada |
| Halifax | Nova Scotia | B3H 1Z4 | Canada |
| 17538803 | Background | Fleischer AB Jr, Abramovits W, Breneman D, Jaracz E; US/Canada tacrolimus ointment study group. Tacrolimus ointment is more effective than pimecrolimus cream in adult patients with moderate to very severe atopic dermatitis. J Dermatolog Treat. 2007;18(3):151-7. doi: 10.1080/09546630701287332. |
| 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 |
| C117268 | pimecrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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