Claims for Patent: 9,060,730

Summary for Patent: 9,060,730

Title:	Method and kit for quantifying risk predictor
Abstract:	A method and a kit for quantification of at least one predictor promoting at least one multifactorial disease, intended for use in assessment of the risk for developing or progression of the at least one multifactorial disease for a subject are disclosed. The kit comprises a plurality of reservoir units (320), each reservoir unit (320) being arranged to releasably retain a skin irritation agent adapted to provoke an unspecific inflammatory response of skin. The kit comprises an estimation unit adapted to estimate a quantification of the at least one predictor on basis of an assessment of the at least one predictor performed by a user on basis of an assessment of the degree of severity of the inflammatory response to the skin irritation agent at each of a plurality of skin sites according to a predetermined inflammatory response criteria performed by the user and relative impact of the at least one predictor on the progress of the at least one multifactorial disease.
Inventor(s):	Lindskog; Sven (Stockholm, SE)
Assignee:	DENTOSYSTEM SCANDINAVIA AB (Stockholm, SE)
Application Number:	13/519,670
Patent Claims:	1. A method for estimating a quantification of at least one predictor promoting at least one multifactorial disease for use in assessment of the risk for developing or progression of the at least one multifactorial disease in a subject, the method comprising: applying a non-endogeneous skin irritation agent in a plurality of skin surface concentrations at a plurality of corresponding skin sites of the subject for a predetermined first period of time, the skin irritation agent being adapted to provoke an unspecific inflammatory response of skin; transforming the non-endogeneous skin irritation agent from an inert state into an active state; assessing in an estimation unit the degree of severity of the inflammatory response to the activated skin irritation agent at each skin site according to a predetermined inflammatory response criteria; on basis of the assessment of the degree of severity of inflammatory response at each skin site, assessing in an estimation unit the at least one predictor; and on basis of the assessment of the at least one predictor and relative impact of the at least one predictor on the progress of the at least one multifactorial disease, estimating in an estimation unit a quantification of the at least one predictor. 2. A method for estimating a quantification of at least one predictor promoting periodontitis for use in assessment of the risk for developing or progression of periodontitis in a subject, the method comprising: applying a non-endogeneous skin irritation agent comprising sodium lauryl sulphate (SLS) in a plurality of skin surface concentrations at a plurality of corresponding skin sites of the subject for a predetermined first period of time, the skin irritation agent being adapted to provoke an unspecific inflammatory response of skin; transforming the non-endogeneous skin irritation agent from an inert state into an active state; assessing in an estimation unit the degree of severity of the inflammatory response to the activated skin irritation agent at each skin site according to a predetermined inflammatory response criteria; on basis of the assessment of the degree of severity of inflammatory response at each skin site, assessing in an estimation unit the at least one predictor; and on basis of the assessment of the at least one predictor and relative impact of the at least one predictor on the progress of periodontitis, estimating in an estimation unit a quantification of the at least one predictor. 3. A method according to claim 1, wherein the a non-endogeneous skin irritation agent comprises: sodium lauryl sulphate and/or ceragenin. 4. A method according to claim 1, wherein the assessment of the degree of severity of the inflammatory response to the skin irritation agent at each skin site according to the predetermined inflammatory response criteria is performed on a condition that a predetermined second period of time has lapsed subsequent to the application of the skin irritation agent in a plurality of skin surface concentrations at a plurality of corresponding skin sites of the subject for the predetermined first period of time. 5. A method according to claim 1, wherein the inflammatory response criteria comprises the number of negative reactions to progressively lower surface concentrations of skin irritation agent with regards to the skin sites. 6. A method according to claim 1, wherein the at least one predictor promotes a multifactorial disease associated with an impaired inflammatory reactivity of the subject. 7. A method according to claim 1, wherein the at least one predictor promotes gingivitis, periodontitis, chronic periodontitis, chronic obstructive pulmonary disease, cardiovascular disease, psoriasis or a combination thereof. 8. A method according to claim 1, wherein the predetermined first period of time is selected within the range of about 18 to 30 hours. 9. A method according to claim 8, wherein the predetermined first period of time is selected within the range of about 23 to 25 hours. 10. A method according to claim 9, further comprising applying a substance, the substance being substantially inert at least with regards to inducing skin irritation, to at least one skin site of the subject for the predetermined period of time concurrently with the application of the skin irritation agent, wherein the predetermined inflammatory response criteria comprises exhibiting an inflammatory response different from the inflammatory response at the at least one skin site where said substance has been applied. 11. A method according to claim 1 for estimating a measure, or quantification, of a predictor promoting periodiontitis comprising: applying a non-endogeneous skin irritation agent to one or more corresponding skin sites of a subject, and transforming the non-endogeneous skin irritation agent from an inert state into an active state. 12. A method according to claim 11, wherein the non-endogeneous skin irritation agent comprises sodium lauryl sulphate (SLS). 13. A kit for quantification of at least one predictor promoting at least one multifactorial disease for use in assessment of the risk for developing or progression of the at least one multifactorial disease for a subject, the kit comprising: a plurality of reservoir units each reservoir unit releasably retaining a non-endogeneous skin irritation agent adapted to provoke an unspecific inflammatory response of skin; the reservoir units being arranged such as to enable, when applied to respective skin sites of the subject, application of skin irritation agent in a plurality of skin surface concentrations at the respective skin sites for a predetermined first period of time; the kit further comprising: an estimation unit configured to estimate a quantification of the at least one predictor on basis of: an assessment of the at least one predictor performed by a user on basis of an assessment of the degree of severity of the inflammatory response to the skin irritation agent at each skin site according to a predetermined inflammatory response criteria performed by the user and relative impact of the at least one predictor on the progress of the at least one multifactorial disease; and at least one activation unit configured to transform at least one skin irritation agent being in an inert state into an active state. 14. A kit according to claim 13, wherein the skin irritation agent comprises: sodium lauryl sulphate and/or ceragenin. 15. A kit according to claim 13, wherein at least one of the plurality of reservoir units comprises a substance adapted to maintain skin irritation agent comprised in the respective reservoir unit in an active state. 16. A kit according to claim 13, wherein the activation unit comprises sterile water. 17. A kit according to claim 13, wherein the activation unit comprises a substance void of water. 18. A kit according to claim 17, wherein the activation unit comprises propylene glycol, ethylene glycol, butylene glycol, propanediol, a poliol, or a combination thereof. 19. A kit according to claim 13, further comprising an adhesive test strip configured to adhere to skin of the subject, wherein the plurality of reservoir units are arranged on the adhesive test strip and the reservoir units are facing the skin of the subject when the test strip is adhered to the skin of the subject. 20. A kit according to claim 13, wherein the activation unit includes an applicator or a pipette. 21. A kit according to claim 13, wherein at least one of the reservoir units includes two or more cells separated by a frangible impermeable seal with one of the cells including an activation substance adapted to selectively transform the at least one skin irritation agent from an inert state into an active state.

Details for Patent 9,060,730

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2039-09-22