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Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Pimecrolimus cream 1% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimecrolimus cream 1% | Drug | Pimecrolimus cream 1% bid, as needed |
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| Measure | Description | Time Frame |
|---|---|---|
| • Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| • Epidermal thickness by optical coherence tomography at selected investigational centers | 48 weeks | |
| Skin thickness by ultrasound at selected investigational centers | 48 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharm | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Novartis | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Reference: Thaci D et al TBD. CORTICOSTEROID-INDUCED SKIN DAMAGE IMPROVED WITH PIMECROLIMUS CREAM 1% TREATMENT: A 1-YEAR STUDY IN ADULTS WITH ATOPIC ECZEMA. European Academy of Dermatology and Venereology - 17th Congress. 2008; www.eadv.org |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| 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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| Epidermal thickness by 3mm punch biopsies (optional) |
| 48 weeks |
| Skin metabolism by suction blisters. | 48 weeks |
| Investigator's Global Assessment (IGA) | 48 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |