Document Detail


An experimental ointment formulation of pimecrolimus is effective in psoriasis without occlusion.
MedLine Citation:
PMID:  14609102     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Pimecrolimus (Elidel, SDZ ASM 981), a new macrolactam ascomycin derivative, was highly effective in treating plaque-type psoriasis when applied under Finn-chamber occlusion. A two-centre, randomized, double-blind, vehicle- and positive-controlled within-patient study was therefore conducted in 23 adult psoriasis patients. Pimecrolimus 1% was applied, twice daily, in an experimental ointment formulation, along with the corresponding vehicle, 0.005% calcipotriol ointment and 0.05% clobetasol-17-propionate ointment to test sites without occlusion for 21 days. Erythema, induration and scaling (score: 0 [absent] to 4 [severe]) were evaluated. The total sign score was defined as the sum of the erythema, induration and scaling scores (range 0-12). Pimecrolimus 1% ointment was significantly (p = 0.03) more effective than the corresponding vehicle, with an improvement in total sign score of 51.4% compared with 36.7% for the corresponding vehicle. Improvements with calcipotriol and clobetasol-17-propionate were 71.5% and 88.3%, respectively. No local or systemic drug-related side effects were observed in the study. We conclude that pimecrolimus 1% in the experimental ointment formulation was significantly more effective than its corresponding vehicle, but less effective than calcipotriol and clobetasol ointment. This is the first study reporting a significant therapeutic effect of pimecrolimus in an ointment formulation applied without occlusion to psoriatic plaques.
Authors:
Ulrich Mrowietz; Stefan Wustlich; Godehart Hoexter; Michael Graeber; Matthias Bräutigam; Thomas Luger
Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Acta dermato-venereologica     Volume:  83     ISSN:  0001-5555     ISO Abbreviation:  Acta Derm. Venereol.     Publication Date:  2003  
Date Detail:
Created Date:  2003-11-11     Completed Date:  2004-03-08     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0370310     Medline TA:  Acta Derm Venereol     Country:  Norway    
Other Details:
Languages:  eng     Pagination:  351-3     Citation Subset:  IM    
Affiliation:
Department of Dermatology, University of Schleswig-Holstein, Campus Kiel, Germany. umrowietz@dermatology.uni-kiel.de
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MeSH Terms
Descriptor/Qualifier:
Administration, Topical
Adult
Double-Blind Method
Female
Humans
Immunosuppressive Agents / administration & dosage*
Male
Middle Aged
Occlusive Dressings
Ointments
Psoriasis / drug therapy*
Tacrolimus / administration & dosage*,  analogs & derivatives*
Treatment Outcome
Vehicles
Chemical
Reg. No./Substance:
0/Immunosuppressive Agents; 0/Ointments; 0/Vehicles; 0/pimecrolimus; 109581-93-3/Tacrolimus

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


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