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Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Pimecrolimus 1 % cream plus topical corticosteroid (TCS) |
|
| 2 | Placebo Comparator | Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimecrolimus plus topical corticosteroid (TCS) | Drug | Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all other adverse events | ||
| Time to relapse of atopic dermatitis | ||
| Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Care Medical Group, Inc. | Huntington Beach | California | 92647 | United States | ||
| Children's Hospital -San Diego |
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| Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) | Drug | twice daily administration |
|
| Efficacy measured by IGA (treatment success and improvement) |
| Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent |
| San Diego |
| California |
| 92123 |
| United States |
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | United States |
| Dermatology Associates and Research | Coral Gables | Florida | 33134 | United States |
| Medical College of Georgia - Clinical Investigative Services | Augusta | Georgia | 30912 | United States |
| Dartmouth Hitchcock Medical Center Section of Dermatology | Lebanon | New Hampshire | 03756 | United States |
| Wake Forest University School of Medicine Dept. of Dermatology | Winston-Salem | North Carolina | 27157 | United States |
| Calcagno Research and Development | Gresham | Oregon | 97030 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| 520 Trinity Creek Cove | Cordova | Tennessee | 38018 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| A.S.T.H.M.A., Inc | Seattle | Washington | 98105 | United States |
| 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 |
|---|---|
| C117268 | pimecrolimus |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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