Document Detail


Topical calcitriol--studies on local tolerance and systemic safety.
MedLine Citation:
PMID:  11501511     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Calcitriol 3 microg g(-1) ointment (Silkis ointment, Galderma Laboratories) is a new treatment for psoriasis. Calcitriol is the biologically active metabolite of vitamin D3. It induces keratinocyte differentiation, inhibits keratinocyte, T-cell and fibroblast proliferation, and inhibits the production of some inflammatory mediators, all contributors to the pathogenesis of psoriasis. Preclinical studies have shown an effect of topical calcitriol on calcium homeostasis at doses higher than those in clinical use. No adverse local events were observed when calcitriol was applied to animal skin. Phase I clinical studies confirmed that calcitriol 3 microg g(-1) ointment is well tolerated in humans. These studies have demonstrated that at the minimal effective concentration of 3 microg g(-1), calcitriol ointment has no discernible photosensitizing or phototoxic potential and no skin irritant or allergic potential in healthy volunteers. Its low systemic absorption through human skin is unlikely to significantly affect calcium homeostasis. This paper summarizes the findings of the preclinical and early clinical studies that provided the foundation of the later Phase II and III clinical trials on efficacy and safety with topical calcitriol 3 microg g(-1) ointment for the treatment of plaque psoriasis.
Authors:
E Rizova; M Corroller
Publication Detail:
Type:  Clinical Trial; Controlled Clinical Trial; Journal Article; Review    
Journal Detail:
Title:  The British journal of dermatology     Volume:  144 Suppl 58     ISSN:  0007-0963     ISO Abbreviation:  Br. J. Dermatol.     Publication Date:  2001 Apr 
Date Detail:
Created Date:  2001-08-14     Completed Date:  2001-09-13     Revised Date:  2005-11-16    
Medline Journal Info:
Nlm Unique ID:  0004041     Medline TA:  Br J Dermatol     Country:  England    
Other Details:
Languages:  eng     Pagination:  3-10     Citation Subset:  IM    
Affiliation:
Galderma R & D, Sophia-Antipolis, France. elena.rizova@galderma.com
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MeSH Terms
Descriptor/Qualifier:
Administration, Cutaneous
Animals
Calcitriol / adverse effects,  pharmacokinetics,  therapeutic use*
Calcium Channel Agonists / adverse effects,  pharmacokinetics,  therapeutic use*
Dose-Response Relationship, Drug
Humans
Psoriasis / drug therapy*
Chemical
Reg. No./Substance:
0/Calcium Channel Agonists; 32222-06-3/Calcitriol

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


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