Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
2000-10-4
pubmed:abstractText
Although skin protective products to prevent irritant skin reactions are in wide use, neither standardized test models to prove differences in efficacy exist, nor has the quality or the reproducibility of results been evaluated in a multicentre approach. This should be mandatory when developing or testing skin care products. Therefore, we have designed a multicentre study in an approach to find a standardized test procedure for the evaluation of skin protective products. In this irritation study, a repeated short-time occlusive irritation test (ROIT) with a standardized protocol has been evaluated in 2 phases (12 days and 5 days protocol) in 4 (n=20) respectively 6 (n=33) skilled centres. The skin reaction was induced by 2 irritants (0.5% aq. SLS and toluene, 2x a day for 30 min). Its modification by 3 different cream bases with different hydrophilicity was analyzed. The irritation was monitored by bioengineering methods (TEWL measurement, colorimetry) and by clinical scoring. The evaluation showed that significant results could already be achieved with the 5-day protocol. Furthermore, in spite of the expected inter-centre variations due to heterogeneity of the individual threshold of irritation, interpretation of clinical score, and inter-instrumental variability, the ranking of the vehicles regarding reduction of the irritant reaction was consistent in all centres.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jun
pubmed:issn
0105-1873
pubmed:author
pubmed:issnType
Print
pubmed:volume
42
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
336-43
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:10871097-Administration, Topical, pubmed-meshheading:10871097-Adult, pubmed-meshheading:10871097-Allergens, pubmed-meshheading:10871097-Biomedical Engineering, pubmed-meshheading:10871097-Body Water, pubmed-meshheading:10871097-Colorimetry, pubmed-meshheading:10871097-Dermatitis, Irritant, pubmed-meshheading:10871097-Female, pubmed-meshheading:10871097-Humans, pubmed-meshheading:10871097-Male, pubmed-meshheading:10871097-Middle Aged, pubmed-meshheading:10871097-Models, Biological, pubmed-meshheading:10871097-Ointments, pubmed-meshheading:10871097-Patch Tests, pubmed-meshheading:10871097-Reproducibility of Results, pubmed-meshheading:10871097-Skin, pubmed-meshheading:10871097-Skin Care, pubmed-meshheading:10871097-Skin Temperature, pubmed-meshheading:10871097-Sodium Dodecyl Sulfate, pubmed-meshheading:10871097-Toluene
pubmed:year
2000
pubmed:articleTitle
Multicentre study for the development of an in vivo model to evaluate the influence of topical formulations on irritation.
pubmed:affiliation
Department of Dermatology, University of Erlangen/Nürnberg, Germany.
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, Non-U.S. Gov't, Multicenter Study, Clinical Trial, Phase II, Clinical Trial, Phase I