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This study is not being conducted in the United States.
To investigate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.) versus once daily (o.d.) in preventing the progression to disease "relapse".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Pimecrolimus b.i.d. |
|
| 2 | Experimental | Pimecrolimus o.d. and placebo o.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimecrolimus | Drug | Pimecrolimus cream 1 % applied twice daily (b.i.d.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to relapse of atopic dermatitis (defined as the exacerbation of atopic dermatitis to the level where a topical corticosteroid or alternative therapy is required). | ||
| Investigators Global Assessment (IGA) and pruritus (itch) assessment of atopic dermatitis at time of suspected relapse |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first recurrence of atopic dermatitis | ||
| Eczema Area and Severity Index (EASI) and IGA assessments at several time points. |
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Inclusion criteria - Screening/Run-In Period
Exclusion Criteria:Screening/Run-In period
Inclusion criteria - Double-blind Maintenance treatment period
- Achieve complete remission of active disease (no signs or symptoms of AD) without incidence of "relapse" by the end of 6-week Run-In period (may be earlier); or who achieve "disease improvement" (decrease in IGA score by 1 full point confirmed by the investigator) without incidence of relapse at the end of the 6-week Run-In period
Exclusion criteria - Double-blind Maintenance treatment period
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharma AG | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| This study is not being conducted in the United States | Novartis Pharma AG | Basel | Switzerland |
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| 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 |
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| ID | Term |
|---|---|
| C117268 | pimecrolimus |
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| Pimecrolimus | Drug | Pimecrolimus cream 1 % applied once daily (o.d.) and placebo applied once daily (o.d.) |
|
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |