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The purpose of the study is to determine the impact of topical corticosteroids on the safety and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo in the long-term management of Atopic Dermatitis
Study includes an interim short-term, open label period. Patients could also receive a second course of open label treatment dependent on disease exacerbation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1A | Experimental |
| |
| 1B | Active Comparator |
| |
| 2 | Experimental | Open label |
|
| 3A | Experimental |
| |
| 3B | Placebo Comparator |
| |
| 4 | Experimental | Open label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protopic | Drug | topical |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients reporting cutaneous adverse events overall | Day 4 through end of study |
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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 |
|---|---|---|---|---|---|---|
| Investigational Site | Birmingham | Alabama | 35205 | United States | ||
| Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18359127 | Background | Breneman D, Fleischer AB Jr, Abramovits W, Zeichner J, Gold MH, Kirsner RS, Shull TF, Crowe AW, Jaracz E, Hanifin JM; Tacrolimus Ointment Study Group. Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle. J Am Acad Dermatol. 2008 Jun;58(6):990-9. doi: 10.1016/j.jaad.2008.02.008. Epub 2008 Mar 21. | |
| 19015204 |
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| Corticosteroid | Drug | topical |
|
| placebo | Drug | topical |
|
| Irvine |
| California |
| 92697 |
| United States |
| Investigational Site | Loma Linda | California | 92354 | United States |
| Investigational Site | San Diego | California | 92123 | United States |
| New Haven | Connecticut | 06519 | United States |
| Miami | Florida | 33136 | United States |
| Investigational Site | Atlanta | Georgia | 30322 | United States |
| Investigational Site | Chicago | Illinois | 60611 | United States |
| Chicago | Illinois | 60612 | United States |
| Investigational Site | Chicago | Illinois | 60614 | United States |
| Lexington | Kentucky | 40536 | United States |
| Baltimore | Maryland | 21205 | United States |
| Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| Investigational Site | Detroit | Michigan | 48202 | United States |
| Investigational Site | St Louis | Missouri | 63110 | United States |
| Investigational Site | Lebanon | New Hampshire | 03756 | United States |
| Investigational Site | New York | New York | 10029 | United States |
| Investigational Site | Winston-Salem | North Carolina | 27157 | United States |
| Investigational Site | Cincinnati | Ohio | 45219 | United States |
| Investigational Site | Portland | Oregon | 97201 | United States |
| Investigational Site | Philadelphia | Pennsylvania | 19115 | United States |
| Investigational Site | Nashville | Tennessee | 37215 | United States |
| Investigational Site | Dallas | Texas | 75230 | United States |
| Investigational Site | Dallas | Texas | 75390 | United States |
| Background |
| Paller AS, Eichenfield LF, Kirsner RS, Shull T, Jaracz E, Simpson EL; US Tacrolimus Ointment Study Group. Three times weekly tacrolimus ointment reduces relapse in stabilized atopic dermatitis: a new paradigm for use. Pediatrics. 2008 Dec;122(6):e1210-8. doi: 10.1542/peds.2008-1343. Epub 2008 Nov 17. |
| 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 |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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