| Sustained efficacy and safety of pimecrolimus cream 1% when used long-term (up to 26 weeks) to treat children with atopic dermatitis. | |
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MedLine Citation:
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PMID: 18577032 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Atopic dermatitis is a chronic, inflammatory condition affecting up to 20% of children. Here, we report the long-term extension study of previously published pivotal phase III studies with pimecrolimus cream 1%. Two identical, 26-week studies (6-week, double-blind, followed by 20-week, open-label phases) were conducted in children aged 2 to 17 years with atopic dermatitis. Pooled efficacy and safety analyses were performed. At day 43, 34.8% pimecrolimus-treated patients versus 18.4% in the vehicle group (p < 0.001) were clear/almost clear (Investigators' Global Assessment 0/1) of disease, with significant differences (p < 0.05) between treatment groups for all double-blind visits in all parameters. Pimecrolimus was significantly more effective (based on the Eczema Area and Severity Index) in treating the face and neck versus the rest of the body (p < 0.0001) and versus vehicle (p < 0.0001) in the double-blind phase. Disease control was sustained in the pimecrolimus group throughout the whole study. Patients treated with vehicle during the double-blind phase experienced rapid, marked improvement when switched to pimecrolimus in the open-label phase. The incidence of adverse events was low and comparable between treatment groups. In conclusion, pimecrolimus cream 1% is effective and well tolerated in the long-term control of children with mild to moderately severe atopic dermatitis. |
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Authors:
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Richard G B Langley; Lawrence F Eichenfield; Anne W Lucky; Mark Boguniewicz; Nathalie Barbier; Robert Cherill |
Publication Detail:
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Type: Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Pediatric dermatology Volume: 25 ISSN: 1525-1470 ISO Abbreviation: Pediatr Dermatol Publication Date: 2008 May-Jun |
Date Detail:
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Created Date: 2008-06-25 Completed Date: 2008-08-28 Revised Date: 2009-03-03 |
Medline Journal Info:
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Nlm Unique ID: 8406799 Medline TA: Pediatr Dermatol Country: United States |
Other Details:
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Languages: eng Pagination: 301-7 Citation Subset: IM |
Affiliation:
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Dalhousie University and Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada. rgblangl@dal.ca |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Cutaneous Adolescent Analysis of Variance Child Child, Preschool Dermatitis, Atopic / complications, drug therapy*, pathology Double-Blind Method Drug Administration Schedule Female Humans Immunosuppressive Agents / administration & dosage*, adverse effects Infant Male Pruritus / etiology Severity of Illness Index Skin / pathology Statistics, Nonparametric Tacrolimus / administration & dosage, adverse effects, analogs & derivatives* Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Immunosuppressive Agents; 0/pimecrolimus; 109581-93-3/Tacrolimus |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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