title: In vitro and in vivo evaluation of the effect of barrier gels in nickel contact allergy.
abstract: The protective effect of various ethylenediaminetetraacetate (EDTA) barrier gels on nickel skin penetration was investigated in an in vitro model using human skin. Application of the gels seemed to cause an increased release of nickel from nickel alloys. This nickel did not penetrate the skin barrier but was found to be immobilized on the skin surface. This emphasized the importance of washing the skin surface to remove any surplus of barrier formulation after use, since considerable amounts of nickel will be bound in this formulation. It was found that application of the barrier gels beneath the nickel alloy in contact with the skin significantly reduced the amount of nickel found in the epidermal skin layer. In vivo patch testing with a disc of nickel alloy, with and without use of barrier gel, was performed in 21 nickel-sensitive patients. Patch testing with the nickel alloy without use of barrier gel resulted in positive patch test reactions in 11/21 (52.4%) of the patients tested. Application of a Carbopol gel with 10% CaNa2-EDTA beneath the nickel disc completely abrogated the allergic contact response in all 21/21 (100%) patients. A Carbopol gel without CaNa2-EDTA was less effective, inhibiting the response in 15/21 (71.4%). A high concordance was found between epidermal nickel levels found in vitro and the in vivo patch test.
authors.affiliation: Department of Pharmaceutics, Royal Danish School of Pharmacy, Copenhagen.
authors.forename: A
authors.initials: A
authors.lastname: Fullerton
authors.forename: T
authors.initials: T
authors.lastname: Menné
mesh_terms: D001940:Breast; D003877:Dermatitis, Contact / Q000517:prevention & control*; D004492:Edetic Acid / Q000737:chemistry* / Q000627:therapeutic use; D004817:Epidermis / Q000737:chemistry / Q000187:drug effects; D005260:Female; D005782:Gels; D006801:Humans; D066298:In Vitro Techniques; D008297:Male; D009532:Nickel / Q000009:adverse effects* / Q000493:pharmacokinetics; D010328:Patch Tests; D012869:Skin Absorption
chemical_list: D005782:Gels; D009532:Nickel; D004492:Edetic Acid