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A study to compare the safety and efficacy of Protopic and Elidel in treating mild Atopic Dermatitis in pediatric patients
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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 |
|---|---|---|---|---|---|---|
| San Diego | California | 92123 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 20107727 |
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| pimecrolimus cream | Drug | topical |
|
|
| 6 Weeks |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Miami | Florida | 33136 | United States |
| Miami | Florida | 33155 | United States |
| Chicago | Illinois | 60614 | United States |
| Boston | Massachusetts | 02115 | United States |
| Clinton Township | Michigan | 48308 | United States |
| Fridley | Minnesota | 55432 | United States |
| Omaha | Nebraska | 68144 | United States |
| Reno | Nevada | 89511 | United States |
| Durham | North Carolina | 27705 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Cleveland | Ohio | 44106 | United States |
| Portland | Oregon | 97201 | United States |
| Pittsburgh | Pennsylvania | 15218 | United States |
| Dallas | Texas | 75390 | United States |
| Galveston | Texas | 77555 | United States |
| Houston | Texas | 62016 | United States |
| 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. |
| 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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