Document Detail


The safety and efficacy of pimecrolimus, 1%, cream for the treatment of Netherton syndrome: results from an exploratory study.
MedLine Citation:
PMID:  20083693     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Impaired skin integrity in patients with Netherton syndrome (NS) results in significant systemic absorption of topically applied medications. Some have advocated the administration of pimecrolimus, 1%, topical cream for the treatment of patients with NS. Insufficient data exist with regard to its safety, systemic absorption, and efficacy. OBSERVATIONS: An exploratory study was conducted involving 3 children with NS who received twice-daily application of pimecrolimus, 1%, cream over 18 months. There were no notable abnormalities in hematologic or chemistry profiles. Blood levels of pimecrolimus ranged from 0.625 to 7.08 ng/mL, with peak levels reached during the first month in all 3 patients. Dramatic reductions were observed in the Netherton Area and Severity Assessment, Eczema Area and Severity Index, Investigator Global Evaluation of Disease, and pruritus scores compared with baseline levels. CONCLUSIONS: Use of pimecrolimus, 1%, cream was well tolerated and demonstrated marked improvements in nearly all of the parameters evaluated. Patients treated with pimecrolimus responded rapidly, within the first month of treatment, and improvement persisted throughout the study period. In adult patients receiving oral pimecrolimus, blood levels as high as 54 ng/mL for 3 months have not shown clinically significant immunosuppression. Absorption of pimecrolimus, 1%, cream was detectable, but levels were much lower than expected even when applied to 50% of total body surface area. Larger studies are warranted to determine the safety and efficacy of pimecrolimus, 1%, cream in the treatment of NS. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00208026.
Authors:
Albert C Yan; Paul J Honig; Michael E Ming; Janice Weber; Kara N Shah
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Archives of dermatology     Volume:  146     ISSN:  1538-3652     ISO Abbreviation:  Arch Dermatol     Publication Date:  2010 Jan 
Date Detail:
Created Date:  2010-01-19     Completed Date:  2010-02-18     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372433     Medline TA:  Arch Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  57-62     Citation Subset:  AIM; IM    
Affiliation:
Section of Dermatology, Children's Hospital of Philadelphia, University of Pennsylvania School of Medicine, 3550 Market St, Second Floor, Philadelphia, PA 19104, USA. yana@email.chop.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00208026
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MeSH Terms
Descriptor/Qualifier:
Administration, Topical
Calcineurin / antagonists & inhibitors
Child
Dermatologic Agents / administration & dosage*,  pharmacokinetics
Dose-Response Relationship, Drug
Drug Administration Schedule
Eczema / drug therapy*,  etiology,  pathology
Female
Follow-Up Studies
Humans
Netherton Syndrome / blood,  complications,  drug therapy*
Ointments
Quality of Life
Skin / drug effects*,  pathology
Skin Absorption
Tacrolimus / administration & dosage,  analogs & derivatives*,  pharmacokinetics
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Dermatologic Agents; 0/Ointments; 0/pimecrolimus; 109581-93-3/Tacrolimus; EC 3.1.3.16/Calcineurin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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