title: Multicentre study for the development of an in vivo model to evaluate the influence of topical formulations on irritation.
abstract: 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.
authors.affiliation: Department of Dermatology, University of Erlangen/Nürnberg, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Schnetz
authors.forename: T L
authors.initials: TL
authors.lastname: Diepgen
authors.forename: P
authors.initials: P
authors.lastname: Elsner
authors.forename: P J
authors.initials: PJ
authors.lastname: Frosch
authors.forename: A J
authors.initials: AJ
authors.lastname: Klotz
authors.forename: J
authors.initials: J
authors.lastname: Kresken
authors.forename: O
authors.initials: O
authors.lastname: Kuss
authors.forename: H
authors.initials: H
authors.lastname: Merk
authors.forename: H J
authors.initials: HJ
authors.lastname: Schwanitz
authors.forename: W
authors.initials: W
authors.lastname: Wigger-Alberti
authors.forename: M
authors.initials: M
authors.lastname: Fartasch
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000485:Allergens / Q000009:adverse effects; D001698:Biomedical Engineering; D001834:Body Water / Q000378:metabolism; D003124:Colorimetry; D017453:Dermatitis, Irritant / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D009824:Ointments; D010328:Patch Tests / Q000592:standards*; D015203:Reproducibility of Results; D012867:Skin / Q000187:drug effects* / Q000378:metabolism; D017592:Skin Care / Q000592:standards*; D012881:Skin Temperature; D012967:Sodium Dodecyl Sulfate / Q000009:adverse effects; D014050:Toluene / Q000009:adverse effects
chemical_list: D000485:Allergens; D009824:Ointments; D012967:Sodium Dodecyl Sulfate; D014050:Toluene