Test patch and its use for demonstrating contact allergy

• US 5,614,167 A
• Filed: 01/30/1995
• Issued: 03/25/1997
• Est. Priority Date: 05/25/1987
• Status: Expired due to Term

• Current Assignee: Mekos Laboratories A/S
• Original Assignee: Pharmacia & Upjohn AB (Pharmacia Corp.)
• Inventors: Hansen, Jens, Kreilg.ang.rd, Bo
• Primary Examiner(s): Weddington, Kevin E.
• Application Number:
  US08/380,784
• Time in Patent Office: 785 Days
• Field of Search: 424/9.2, 424/78.24, 424/443, 424/444, 424/445, 424/446, 424/447, 424/448, 424/449, 128/734, 514/535, 514/58, 514/724, 514/642, 514/694, 514/372
• US Class Current: 424/9.2
• CPC Class Codes: A61B 10/0035 Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches

Abstract

##STR1## Occlusive epicutaneous testing strip and method for demonstrating whether or not an individual suffers from contact allergy to a test substance. The test strip has at least one patch on which the test substance is incorporated in a vehicle formulated as a film which adheres to the patch and contains at least one film-forming polymer capable of absorbing moisture which when the strip is being used is secreted from the skin area tested. The characteristic feature of the strip is that on at least one of the patches on which said vehicle is formulated as a film the said polymer has the structure (I), where n is the number of times that the structure within brackets is repeated and may be ≧100, and A is a straight or branched alkylene group having a length of 3-5 carbon atoms.

Claims

1. A method of occlusive epicutaneous testing to ascertain whether an individual suffers from contact allergy, which method comprises applying to the skin of the individual a test strip which has at least one patch having a test substance containing a plurality of allergenic components, said test substance on said at least one patch being incorporated in a vehicle which is formulated as a film adhering to the patch and containing at least one film-forming polymer (I) capable of absorbing moisture which is secreted from the skin area being tested when the strip is in use, wherein on at least one patch on which said vehicle is formulated as a film, the film forming polymer (I) is poly(N-vinyl-2-pyrrolidone), whereby a positive test result occurs when an allergic reaction is observed on the skin.

2. A method according to claim 1, wherein the test substance which is incorporated in the vehicle containing poly(N-vinyl-2-pyrrolidone) comprises allergenic components having an aromatic structure.

3. A method according to claim 1, wherein at least one of said allergenic components is selected from the group consisting of a mixture of 5-chloro-2-methyl-4-isothiazoline-3-one and 2-methyl-4-isothiazoline-3-one, mercapto mix, perfume, geraniol, cinnamic aldehyde, hydroxycitronellate, cinnamic alcohol, eugenol, isoeugenol, alpha-amyl cinnamic aldehyde, wool wax, caine mix, parabenes and cyclodextrin complexes.

4. A method according to claim 1, wherein at least one allergenic component includes a polar or ionic grouping selected from the group consisting of primary, secondary, tertiary and quaternary amines, carboxyl, ketone, aldehyde, mercapto, nitro, aromatic and non aromatic conjugated double bond groups.

5. A method of occlusive epicutaneous testing to ascertain whether an individual suffers from a contact allergy, which method comprises applying to the skin of the individual a test strip which has at least one patch having a test substance containing a plurality of allergenic components, said test substance on said at least one patch being incorporated in a vehicle which is formulated as a film adhering to the patch and containing at least one film-forming polymer (I) capable of absorbing moisture which is secreted from the skin area being tested when the strip is in use, wherein on at least one patch on which said vehicle is formulated as a film, the film-forming polymer (I) is a mixture of at least two poly(N-vinyl-2-pyrrolidone) polymers of different molecular weights, whereby a positive test result occurs when an allergic reaction is observed on the skin.

6. A method according to claim 5, wherein the test substance which is incorporated in the vehicle containing poly(N-vinyl-2-pyrrolidone) comprises allergenic components having an aromatic structure.

7. A method of occlusive epicutaneous testing to ascertain whether an individual suffers from a contact allergy, which method comprises applying to the skin of the individual a test strip which has at least one patch having a test substance containing a plurality of allergenic components, said test substance on said at least one patch being incorporated in a vehicle which is formulated as a film adhering to the patch and containing at least one film-forming polymer (I) capable of absorbing moisture which is secreted from the skin area being tested when the strip is in use, wherein on at least one patch on which said vehicle is formulated as a film, the polymer (I) has the structure ##STR3## wherein n is the number of times that the structure within brackets is repeated and is ≧

100, and A is a straight or branched alkylene group having a length of 3-5 carbon atoms, whereby a positive test result occurs when an allergic reaction is observed on the skin.